Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 13/30/02. The contractual start date was in April 2014. The draft report began editorial review in July 2015 and was accepted for publication in November 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

During this study Simon Lalor was an employee of Opcare, a company that provides orthotic and prosthetic services to the UK NHS. This company does not manufacture orthotic devices, although a sister company ORTHO C FAB does. Cynthia Iglesias is a member of the National Institute for Health and Care Excellence Medical Technologies Assessment Committee and member of the European Clinical Research Infrastructure Network.

Copyright statement

© Queen’s Printer and Controller of HMSO 2016. This work was produced by O’Connor et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Introduction

This project was undertaken in response to a commissioning brief from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) to address the question of which devices are in use in the UK NHS for instability of the knee in adults with neuromuscular disease (NMD), which conditions these devices are used for, and what further research is needed. The purpose of the commissioned research was to inform development of a future substantive research question to assess the clinical effectiveness and cost-effectiveness of different types of orthotic management of the knee in people with neuromuscular and central nervous system (CNS) diseases.

Neuromuscular disease

The term ‘NMD’ encompasses a heterogeneous group of conditions, and terminology can vary. Neurology practice in the UK recognises NMDs as conditions that primarily affect the peripheral nerve, muscle and/or neuromuscular junction. Hilton-Jones et al. 1 describe the term as covering any condition caused by dysfunction of the motor unit (the motor nerve and the muscle it controls). They identify four anatomical sites: the anterior horn cell/motor neuron (e.g. poliomyelitis and motor neurone disease); the peripheral nerve [e.g. Charcot–Marie–Tooth (CMT) disease]; the neuromuscular junction (e.g. myasthenia gravis) and the muscle (e.g. muscular dystrophy). 1 There is a wide variety of pathologies, motor impairments and comorbidities across these neuromuscular disorders, for instance peripheral nerve conditions, which may be sensory as well as motor; neuromuscular junction conditions, for which there may be a large element of variability and physiological fatigue; and muscle conditions, which will vary in comorbidities such as cardiomyopathy and respiratory impairment. The exact muscle groups affected will vary both between and within individual conditions. However, there are common factors, particularly muscle weakness and fatigue, which affect mobility and lower limb function.

The term NMD is sometimes used in a more inclusive way, encompassing upper motor neuron conditions that have a common end point of affecting muscle function. This definition would therefore include CNS disorders, such as multiple sclerosis and stroke. Clinical management of people with primarily CNS conditions will often differ from the conditions described above because of the effect of upper motor neuron features on lower limb function. For example, spasticity will influence the prescription of orthoses in conditions such as multiple sclerosis. Likewise, in patients who have experienced a stroke, issues such as spasticity, neglect and spatial awareness will have an impact, plus there is acute onset usually with improvement and plateau. At the request of the commissioners, the term NMD is used inclusively to also encompass knee instability that related to CNS conditions, and both groups of conditions are included in this research.

Knee instability in neuromuscular disease

There are several mechanisms that may lead to knee instability in NMD. The knee is a polycentric hinge joint that also has a rotatory action, with articular surfaces between the femur and the tibia, and the patella and femur. The muscle groups that have a direct effect on the knee are the knee extensors, comprising the quadriceps femoris and tensor fasciae latae, and the knee flexors that include the hamstring group – sartorius, gracilis and gastrocnemius. Weakness in any of these muscles is one mechanism that may lead to knee instability. This would be particularly common in muscle conditions that are predominantly limb girdle in origin; peripheral nerve conditions that affect these muscles, such as diabetic amyotrophy or poliomyelitis; or in upper motor neuron conditions that affect the lower limb. This could be unilateral or bilateral, according to condition. Weakness in these muscle groups, or in more remote muscle groups, might also lead to secondary impairment of the tendons, ligaments and cartilage, such as laxity and contracture, associated with the knee due to altered alignment and redistribution of force across the joints and soft tissue. Muscle weakness, or overactivity remote from the muscles directly affecting the knee, may also cause knee instability due to the secondary effects on posture, such as excessive plantar flexion leading to abnormal anterior progression of the ground reaction force under the foot.

Sensory impairment can affect joint control where proprioceptive loss may reduce awareness of the knee position. Reduced pain or pressure perception may also increase skin vulnerability to excessive pressure or friction, for example from an orthosis. Knee instability itself may be in any of the planes in which the knee can move, that is, anteroposterior, medial–lateral and rotational (transverse plane).

In the case of CNS conditions, spasticity in the muscles acting around the knee can also cause knee instability. For example, spasticity in the gastrocnemius, which causes the foot to plantarflex in stance, shifts the ground reaction force anterior to the knee. Over time, this overstretches the posterior capsule of the knee joint, causing the knee to hyperextend. Similarly, spasticity in the hamstring muscles causes the knee to be flexed in stance phase, inducing knee flexion and associated joint instability.

Orthotic devices for knee instability

Knee instability due to muscle weakness or ligamentous laxity is often treated using orthoses. The commonly stated goals of lower limb orthoses are to improve the ability and quality of walking, protect, stabilise and improve function. 2

A knee–ankle–foot orthosis (KAFO) is usually prescribed when other forms of bracing, such as an ankle–foot orthosis (AFO) or knee orthosis (KO), are insufficient to adequately control knee instability due to weakness or joint laxity. 2 KAFOs span the knee, ankle and foot to stabilise the joints and assist safe ambulation. There are many types of KAFO designs. ‘Conventional’ KAFOs, made of metal and leather, have been used for centuries. Modern KAFOs, made from thermoplastics or carbon fibre composites, are lighter and fit more closely, potentially affording better control of the limb. Modern KAFOs tend to combine plastic and metal components, commonly polypropylene for calf and thigh shells and shoe inserts; aluminium, magnesium, titanium or steel for uprights; and steel for joints. 3 Devices can also vary in the type of knee joint, type of knee locking mechanism, types of knee pads and bands and whether or not there is frontal plane control. 3

Historically, KAFOs were either entirely locked or entirely unlocked at the knee. 4 Most KAFOs incorporate knee joints that lock the knee straight during walking and unlock only when the user sits. Using a KAFO with a locked knee requires the individual to alter their gait to allow their foot to clear the ground in the swing phase of walking. Polycentric knee joints can be locked or unlocked and allow a more natural knee motion, although they have more moving parts, require more maintenance and are therefore more expensive. 3 They can also be heavier and bulkier, require the wearer to have voluntary hip extension and can be problematic when walking on uneven surfaces. Recent years have seen the introduction of stance control knee joint technology, through which mechanical or microprocessor controlled knee joints allow the knee to flex during the swing phase of walking but lock when the knee is extended during stance phase of walking and when weight is borne through the leg to provide stability to the knee in order to allow a more normal walking pattern. These are generally known as stance control KAFOs (SCKAFOs). KAFOs can be worn unilaterally or bilaterally as required.

Hip KAFOs (HKAFOs) are KAFOs that extend across the hip joint connecting to a pelvic band or lumbar/thoracic spinal support. 4 Bilateral KAFOs are linked via hip joints with flexion stops and a release mechanism for sitting. 4 Hip guidance orthoses (HGOs) and reciprocating gait orthoses (RGOs) are examples of HKAFOs with different locking/unlocking mechanisms. Ambulation with these devices by individuals with extensive paresis or paralysis of the lower limbs usually requires additional walking aids, such as crutches or walking frames. 4 These devices were originally designed for patients with higher-level spinal cord dysfunction, who might otherwise not have been able to walk. 5 Modifications of RGOs include the advanced RGO (ARGO) and the isocentric RGO (IRGO). 5

Knee stability can also be improved by the use of knee braces or KOs, or in some cases by a type of AFO known as a ground reaction AFO (GRAFO). An AFO provides direct control of the ankle and foot, and is used to support mobility in people who experience joint instability, muscle weakness or muscle spasticity at the ankle joint. However, it can also provide indirect control of the knee and hip, and may be of benefit for knee instability. Quality Improvement Scotland has issued a Best Practice Statement on the use of AFOs following stroke. 6 The statement recommends that assessment for the orthotic device should be undertaken jointly by a specialist orthotist and specialist physiotherapist, and that the design specification should be based on biomechanical principles and desired functional outcomes of the patient.

The above devices can be prefabricated/off-the-shelf or fully custom-made. Some off-the-shelf devices may be customised to the individual. The clinical effectiveness of the various orthotic options for knee instability related to NMD is unclear. Diagnosis is thought to be a poor predictor of the type of orthosis that will be most effective. Orthosis design should be driven by the specific biomechanical impairments of each individual patient, the rehabilitation goals of the multidisciplinary team (MDT) and the patient’s own goals. In addition to technical and structural considerations to ensure stability and safety, the clinician who is fitting the device needs to understand the goals of the orthosis within a patient’s living and working circumstances. 7 Devices are generally fitted for the individual patient, and the correct supply and fitting of orthotic devices is important to allow a patient to manage his or her condition or prevent future problems.

Factors to be considered when prescribing and fitting a device are the type of deformity or instability present, the biomechanical deficit to be addressed, patient weight and activity level, and lifestyle issues. Patients with significant fixed deformity may benefit from a weight-relieving brim in the orthosis, so that some of the patient’s weight can be offloaded from the affected leg. The biomechanical deficit will influence the way that forces are applied to the limb by the orthosis, the trimlines of the orthosis and the type of materials chosen. Weight and activity level will influence material choice, including the type of side bars and joints used. An important consideration when prescribing and fitting a device is whether off-the-shelf orthoses will meet the needs of the patient or a bespoke device is required. This decision will be influenced by the size and body habitus of the patient, the need to control certain movements as a result of the weakness in the limb, and the experience and skill of the orthotist in fabricating a device.

Most orthotic devices are classified as class 1 (lowest level of risk) with a Conformité Européenne (CE) mark. 8 There is a legal requirement for class 1 devices to meet the requirements of the European Union Medical Device Directive. Following registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and self-declaration, the CE mark (which declares conformity with the Medical Devices Directive) can then be put on the product. A CE mark is not required for custom-made orthoses, although they must meet the requirements of the relevant sections of the Medical Devices Regulations. 9 A custom-made device is defined by MHRA as being ‘manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other authorised person . . . which gives under his responsibility, specific characteristics as to its design; and intended for the sole use of a particular patient’. 9 The prescription can take the form of a letter or a moulded impression of the shape of device required, with a request to ‘make as pattern’. 9

Provision of orthoses

Orthotists in the NHS work closely with several clinical specialties, ranging from orthopaedics to diabetes care to rheumatology, and they provide services to people with a range of other conditions as well as NMD. There are an estimated 1.2 million people using orthotic services in the NHS. 10 An Audit Commission report in 2000 found that in most hospital trusts, orthotics services were small-scale, with an annual expenditure of < £500,000, although there were also a small number of trusts with an expenditure of > £2M. 11 The Audit Commission report11 estimated that in the study sites, 8% of orthotic expenditure was on KAFOs, 9% on HKAFOs and 1% on AFOs. Lower limb orthosis repair accounted for 2% of expenditure. They found a wide variation in the prices quoted by different suppliers for identical products: across four suppliers the cost of a KAFO ranged from £390 to £650 and the cost of an AFO ranged from £40 to £130 (approximate values read from graph). 11

Orthotics services are normally provided in secondary care using a number of different models of provision: in-house service employing a NHS orthotist; employing a NHS orthotist in conjunction with neighbouring trusts; outsourcing the service to a commercial supplier; or a mix of public and private provision. 11 Based on a survey of 150 orthotics managers in acute trusts, the Audit Commission found that 20% employed their own orthotist. 11

Physiotherapists, neurologists and rehabilitation medicine physicians are also involved in the prescription of orthoses for people with NMD. Physiotherapists are often the first professionals who may prescribe orthoses. These tend to be off-the-shelf devices. For more complex situations, the physiotherapist will refer to, and liaise with, an orthotics clinic. Some clinics have a specialist physiotherapist as part of the team but this is not universal. A survey, in 2004–5, of clinicians running specialist clinics for adults with NMD found that the availability of specialist orthotics in the form of an orthotist with experience in NMDs was low in the 32 clinics surveyed. 12

Patient perspective

There is uncertainty about the acceptability of these devices to patients, the extent to which prescribed devices are used, and the factors that determine their usage. Information on acceptability and use has not been collated systematically in relation to people with neuromuscular conditions that lead to knee instability. The lack of a consistent and reliable method of reporting on the daily use of KAFOs after the patient leaves the clinic or laboratory setting has been highlighted. 2

Phillips et al. 13 explored perceptions and experiences of the disadvantages and benefits associated with use of AFO in 15 people with CMT disease, using individual interviews and nominal group technique. Barriers to use that were identified related to the functional use of the AFO (such as lack of mobility in tight spaces); discomfort when wearing the device, including rubbing and digging into the skin; concerns about the appearance of the device and its potential for drawing attention to disability; and problems with finding suitable footwear. The main perceived advantages of wearing the AFO were linked to improvements in walking. Vinci and Gargiulo14 explored acceptability of AFOs to a study sample of 8 male and 17 female participants with CMT disease, who had severe bilateral foot drop, and who had been prescribed AFOs at least 4 months before the start of the study. Results from this qualitative interview study indicated that adherence to the prescribed AFOs was poor, with only five people (20% of the sample) wearing the devices. Reasons for not wearing AFOs were that patients preferred to manage without them because they felt that the AFOs highlighted their disability, the AFOs were uncomfortable, and they had difficulty finding footwear to accommodate the devices. A third study15 explored the differences in presentation and gait function of people with CMT disease who wore AFOs for daily mobility (n = 11) and a group who did not (n = 21). Six of the non-users had been prescribed AFOs but chose not to wear them. Their physical characteristics resembled the non-AFO group more than the AFO group for measures of muscle strength and disease severity. The authors of this study15 concluded that severity of presentation seems to determine whether or not people with CMT disease will use AFOs, and the timing of prescription may accordingly assist with acceptability of the devices.

Garralda et al. 16 explored the views and adjustment of families with a child with Duchenne muscular dystrophy in relation to use of KAFOs. The authors conducted interviews with 17 parents and 9 children (all boys aged 8–18 years) seeking views about the use of KAFOs. Findings from the study revealed the emotional significance for parents of the introduction of KAFOs as an indicator of illness deterioration and re-affirmation of the severity and life-limiting nature of the disorder. Most parents expressed satisfaction with the use of KAFOs, but some wished to have had more discussion about practical aspects beforehand.

In a trial of AFOs,17 only 50% of stroke patients actually wore their orthoses. Long-term rejection rates of KAFOs have been found to be high in people with paraplegia and with spinal cord lesions. 7 One study suggested that a patient selection and training programme could help target the orthoses at those who were more likely to have successful outcomes. 18 The importance of appropriate training with the orthosis and associated assistive devices has been previously emphasised. 19 It has been suggested that rejection might, in some instances, be due solely to lack of appropriate gait training. 2 The need for training for orthosis users in the care of the orthosis and care of the skin to avoid adverse effects has also been recommended. 19

Other problems that have been cited include auditory distraction, memory of old leather and steel orthoses for patients with poliomyelitis, and damage to clothing. 20 If a patient has unrealistic and unfilled expectations then this may lead to abandoning the orthosis. 2 A patient’s prior history with orthoses and any reasons for previous failure may be important. 2

In summary, the existing research literature relating to patients’ perceptions and experiences of using orthoses for knee instability is limited in several respects. Studies that have been conducted to date are mainly small-scale; some do not include in-depth exploratory techniques, such as face-to-face interviews, and existing studies are not fully representative of the diverse populations with NMD and CNS conditions for whom prescription of an orthosis may be an appropriate measure.

Previous research on effectiveness

Scoping searches were undertaken prior to commencing the current review to establish whether or not a systematic review had been previously undertaken. No previous systematic reviews were identified that assessed the effectiveness of orthotic devices in the specific population of interest: knee instability in adults with NMD and CNS disorders. A systematic review conducted in 2013 (searches to November 2011) found that an AFO fitted in patients following stroke had a statistically significant effect on ankle kinematics, knee kinematics in stance phase, kinetics and energy cost, although not on knee kinematics in swing phase, hip kinematics or energy expenditure. However, the focus was on gait biomechanics, and the effects and acceptability of long-term usage have not been evaluated. 21 A Cochrane review22 has investigated any intervention for CMT disease and identified a single controlled study of foot orthoses (FOs); however, the device was not being used for knee instability – although FOs can influence the alignment of the knee on the coronal plane, they do not correct sagittal plane knee instability. A review of non-surgical interventions for people with CMT disease did not identify any studies evaluating an orthotic device. 23 The literature searches for these reviews were undertaken in 2007 and 2006, respectively, and therefore need to be updated.

An overview of the evidence on KAFOs and HKAFOs for all conditions in 20064 concluded that the level of evidence was generally low and consisted mainly of small study sample sizes and inadequate study design, although these aspects were not addressed in any detail. Two Cochrane reviews24,25 were identified which assessed interventions for ankle instability or reduced range of motion in the ankle in people with NMD, but did not investigate knee instability. A review published in 2012 (searching to 8 November 2010) of stance control orthoses (SCOs) for any condition found benefits of SCOs in comparison with locked KAFOs but these studies had methodological limitations. 26

Aims and objectives

The project aimed to address the commissioned research question of which orthoses are in use in the NHS for instability of the knee, for which NMD and CNS disorders, and what further research is needed. There were four objectives.

1. Assess the evidence base for the effectiveness of orthotic devices for management of instability of the knee in adults who have NMD or a CNS disorder To meet this objective, we undertook a systematic review of the best available evidence on the effectiveness of orthotic devices in this population.

2. Identify the types of orthotic devices currently being provided by the NHS for the management of instability of the knee in adults with NMD or a CNS disorder, the frequency of their use and their cost To meet this objective, we conducted a survey of orthotists and physiotherapists, and undertook a costing analysis of orthoses for knee instability.

3. Identify the most important outcomes for patients To meet this objective, we used qualitative research methods to collate the views of people with NMD or a CNS disorder, who have been fitted with an orthotic device for knee instability.

4. Identify any implications for clinical practice, any gaps in the evidence and future research needs To meet this objective, we interrogated and integrated the three sources of evidence: health-care professionals (HCPs), patients and the systematic review.

Overview

To address the research objectives we undertook (1) a systematic review of the effectiveness of orthotic devices for management of instability of the knee in adults with NMD or CNS disorders; (2) a survey of orthotists and physiotherapists and a costing analysis; and (3) a qualitative study of the perspective of users of orthotic devices. Details of the methods used for each component are outlined below.

Systematic review

The systematic review was designed to identify and evaluate the best available evidence on orthotic devices for the management of instability of the knee in adults with NMD or CNS disorders. We undertook it following the principles recommended by CRD guidance27 and we have reported the review following PRISMA guidelines. 28 The protocol was registered with PROSPERO, registration number CRD42014010180.

Qualitative study of patient views

This exploratory qualitative study aimed to:

1. explore perceptions relating to acceptability, effectiveness and usage of orthoses

2. identify important outcomes among people who have been fitted with an orthotic device for knee instability across a broad range of diverse NMDs

3. explore the factors influencing the perceived likelihood of achieving the outcomes for those individuals within the context of their condition and care pathway.

Survey of health-care professionals

We undertook a web survey of orthotists, physiotherapists and doctors in rehabilitation medicine in order to address the second aim of the project, to identify the types of orthoses currently being used by the NHS for the management of instability of the knee in adults with NMD and CNS disorders, the frequency of their use, the resources required to provide them and the care pathways of these patients. To obtain data for costing orthotic devices, telephone interviews with orthotists were also undertaken.

Costing analysis

Following on from the survey of HCPs, an analysis to estimate the cost of orthotic devices currently being used by the NHS for the management of instability of the knee in adults with NMD and CNS disorders was undertaken. As per the study protocol, the costing analysis involved estimating two components:

1. the resources (e.g. staff and materials) required to provide orthotic devices to patients with NMD and CNS conditions with knee instability

2. the unit costs associated with these resource-use estimates.

Patient and public involvement

We developed an advert and role description (available from authors) to recruit two patients with NMD or CNS conditions with experience of using orthoses for knee problems to join the project Advisory Group. We approached several voluntary organisations to disseminate the opportunity among members: Charcot–Marie–Tooth UK, the Stroke Association, the Spinal Injuries Association, Muscular Dystrophy UK, and the British Polio Fellowship. One individual joined our Advisory Group. At the outset our view was that it was important that we had input from individuals with specific experience of using the devices of interest, as there was very little information available to us about patient perspectives. This limited the pool of people available to us locally, and distance, as well as daytime meetings for people who worked, was a barrier. However, the expertise our public member brought about orthotic devices and how services operate was essential; in particular, their views were sought on the qualitative study and the survey questionnaire. At their suggestion they joined the meeting by Skype™ (Microsoft Corporation, Redmond, WA, USA) and we undertook some work by e-mail. In future projects we would be clearer in advertisements about the possibility of communicating in various ways in addition to, or instead of, face to face. We also undertook various public engagement activities (see Chapter 7), which created the opportunity to speak with individuals from the Yorkshire and Humber Muscle Group and the Polio Survivors Network in the early stages of the project.

Study selection

The search strategies and allied searching identified 4516 references (including update searches). Titles and abstracts were screened and full copies of 532 papers were obtained and assessed for inclusion in the review. Figure 1 shows the flow of studies through the review process and the numbers excluded at each stage. Overall, we included 21 studies reported in 25 publications. 45–69 Three ongoing studies were identified and further details of these are provided in Appendix 10.

FIGURE 1.

Flow of studies through the review process.

Determining eligibility was quite tricky for some studies, as it was sometimes difficult to definitively determine whether or not the problem being managed was knee instability. This was partly because of poor reporting but also because knee instability was sometimes part of a more complex problem with stability and mobility. Seventy-six studies were identified that took place in laboratory or clinical settings without the patient using the orthosis in the community. These were excluded as participants had not had the opportunity to use the orthosis in everyday life. Other reasons for exclusion were that participants did not have a relevant CNS disorder or NMD (n = 80); they were aged < 16 years or the results for adults and children were not reported separately (n = 41); they did not have knee instability (n = 73); they were not using an orthosis (n = 71); no outcomes were reported (n = 38); an inappropriate comparator (n = 1); not a primary study (n = 109); unavailable (n = 18); and background only (n = 25) (some studies had more than one reason for exclusion). A list of the 504 full papers excluded and reason(s) for exclusion is provided in Appendix 11.

Characteristics of included studies

Twenty-one studies were included in the review. 45,47–50,52,53,56–69 An overview of the included studies is presented in Table 1. Full data extraction tables are provided in Appendix 12.

The included studies were published between 198260 and 2013. 48 All were reported as full papers. There were two RCTs (one with a crossover design); two non-randomised studies with a control group (one with a crossover design); one cohort study; and 16 case series (see Table 1). The case series made predominantly before-and-after comparisons either with a previously used device or no device (see Table 1).

The literature is international with studies in China, Japan, Australia, UK, Germany, USA, the Netherlands, France, Belgium, Italy and Israel. Seventeen studies were published in English,45,47–50,52,53,56–62,64,67,68 three in Chinese65,66,69 and one in German. 63 The studies in languages other than English were extracted by a native speaker who was also a researcher with experience of undertaking systematic reviews. These were checked by a second researcher for consistency only.

Overall, 478 patients were included in the review. Sample sizes were small, ranging from 561 to 6769 participants with 11 studies having 20 or fewer participants (see Table 1). Eight of the studies reported knee instability as a result of NMD (153 patients)45,47,49,50,52,56,61,63 (all except one study45 being of patients with post-polio syndrome) and 13 reported knee instability resulting from CNS causes (325 patients),48,53,57–60,62,64–69 either post stroke or spinal cord injury.

Follow-up time was generally short, ranging from 6 weeks61 to 30 months. 56

Study quality

The quality assessments are reported for RCTs (Table 2), non-randomised controlled studies (Table 3) and case series (Table 4). Overall, both RCTs53,69 had a high risk of bias (see Table 2). Owing to poor reporting it was not possible to determine whether or not they were truly randomised studies or to determine whether or not a robust method of allocation concealment had been used. It is not possible to blind participants or clinicians treating them to an orthotic device. Independent outcome assessment would have protected against detection bias; however, there was no evidence of this in either study.

Poor reporting was also an issue for assessing risk of bias in the non-randomised controlled studies and case series. Overall, only one of the non-randomised control studies met all of the three criteria that were related to selection of participants into the study; however, it was unclear if the groups were balanced appropriately for key clinical criteria and it was not possible to assess how complete the follow-up was. 66 As with the RCTs, none reported independent outcome assessment (see Table 3).

Ten of the case series were prospective, three were retrospective and for three there was insufficient information to determine the design (see Table 4). There was a risk of selection bias across all of the case series: eight described their inclusion criteria (see Table 4);47–50,59,61,64,68 for two of the studies52,62 it was not possible to determine if the criteria presented were a priori inclusion criteria or a description of who was included in the study; and the remaining studies did not clearly specify the inclusion criteria. Two case series used a method that suggested that they were likely to have a representative sample, such as a consecutive sample of patients from a clinic, although it was unclear whether or not the participation rate was > 80% and, therefore, selection bias may have been introduced here. 47,52 One study57 reported using independent outcome assessment.

Most studies did not have a comparator group of patients. In just one comparative study62 was it possible to determine that performance bias was not present (i.e. treatment groups were not treated differently). One study57 had an independent assessor, with the remainder assessing follow-up through treating health professionals (i.e. the individuals delivering the intervention also assessed the effectiveness of the intervention) thereby introducing the risk of bias in outcome assessment.

Poor reporting was in evidence across the studies in this review; this was in relation to both study methods and results. In terms of methods, 15 studies45,48,49,52,56–60,62–64,67–69 gave no indication of the orthosis ‘dose’ given to patients (i.e. the time per day/week for which they were advised to use their orthosis). Actual use of the orthoses was not provided in 12 studies. 47–50,52,61,63,65–69 Other study aspects that could also impact on results were under-reported. Participants’ previous use of orthoses was not reported in six studies48,62,63,65–67 and co-interventions were not well reported. In general, results were poorly reported. Studies, in the results section, often made statements that were not backed up with numerical data. When no data have been provided to support statements, this has been highlighted in the relevant results sections that follow. Adverse effects were not investigated or not reported in 17 studies. 45,47–50,52,53,59–63,65–69

We planned to extract data to allow calculation of between-group differences and confidence intervals. However, because of the generally poor reporting of data, it was not possible to consistently do this across studies. When data were available, these were extracted; when the appropriate data were not reported, the description of the results provided in the paper was extracted and the lack of summary data was noted.

Results from studies of patients with post-polio syndrome

Seven studies47,49,50,52,56,61,63 (Table 5) assessed the effects of orthoses on patients with knee instability following poliomyelitis (143 patients). None of the studies was conducted in the UK. All were case series, with four studies having ≤ 11 patients. 47,50,52,61

Four studies49,50,52,61 compared different types of orthoses used by the same participants, three of these were effectively comparisons before and after provision of a new device; in the fourth study,50 participants were provided with a new stance control device and the comparison was between using the device in stance control mode and using it in locked mode (with the aim of replicating a traditional KAFO design). Comparisons were made before and after use of the orthosis in two studies:47,63 and post-intervention only in one study. 56 All orthoses investigated were types of carbon fibre KAFO.

The outcomes were sparsely reported. Five49,52,56,61,63 of seven studies47,49,50,52,56,61,63 reported measures of patient satisfaction, although not in sufficient detail to assess the robustness of the evaluation. Few of the studies reported assessing device functionality, device usage and quality of life (Table 6). Three studies49,50,52 made a formal assessment of walking ability and four studies47,49,50,52 assessed either energy consumption or particular muscle activity. Resource utilisation data were limited to assessment of device malfunction in four studies49,52,56,61 and cost in one study. 52 Five studies47,49,50,52,63 failed to report adverse effects data or to mention that no adverse effects were identified, therefore, it was unclear if adverse effects had been formally assessed or not reported.

Results from studies of patients with inclusion body myositis

One case series study45 (Table 7) assessed the effects of orthoses on patients with knee instability as a result of inclusion body myositis (nine patients). This small study of a rare condition was conducted in the USA. Patient selection criteria for the study were not reported in full and it is unclear if the patients are fully representative of those seen in practice.

A comparison was made between patient gait with and without the SCO after 6 months’ use of the device. Patient feedback on the device was also sought. The study45 did not appear to use an independent outcome assessor and follow-up was incomplete (six of nine had outcome data). A gait assessment was conducted to assess walking ability. An author-designed questionnaire was used to elicit patient outcomes but results were not reported in full, just as textual summaries. No data were reported on resource utilisation or adverse effects (Table 8).

Results from studies of post-stroke patients

Four studies48,58,60,69 (Table 9) assessed the effects of orthoses on patients with knee instability following stroke (131 patients). None of the studies was conducted in the UK. There was one RCT69 that was limited in its reporting, a cohort study60 and two case series48,58 (one of which had only 11 patients).

The studies made varying comparisons. Boudharam et al. 48 undertook gait analysis with and without a carbon fibre KAFO. Kakurai and Akai58 compared patients who had changed to a plastic AFO with those who continued to use a plastic KAFO. This study58 was not comparing two types of devices: the comparison was between those who had recovered sufficient control of knee activity to switch to an AFO device and those who had not. Morinaka et al. 60 compared a plastic KAFO to AFO and to normal adult gait. Yang et al. 69 undertook a RCT comparing AFO or KAFO to conventional rehabilitation (not reported in detail). In one study,48 orthoses were made of carbon fibre, two used plastic orthoses,58,60 and the RCT by Yang et al. 69 did not report the material.

None of the studies reported using an independent outcome assessor to assess outcomes. Duration of follow-up was not reported in two studies,58,69 although the RCT by Yang et al. 69 appeared to conduct an assessment of patients two to three months after treatment. In one study, the device had to have been prescribed in the previous 6 months48 and in the fourth study60 the follow-up was 14.6 months, but in the study with the longer follow-up such follow-up was incomplete (< 80%). 60 Outcomes were sparsely reported (Table 10). No studies assessed patient-reported outcomes, with the exception of Morinaka et al. ,60 who reported solely on the usage of the orthotic device. Three studies48,58,60 made a formal assessment of walking ability and two studies58,69 assessed other functional abilities. No studies reported on resource utilisation data. None reported any adverse effects data or mentioned that no adverse effects were identified.

Results from studies of patients with spinal cord injury

Nine studies53,57,59,62,64–68 (Table 11) assessed the effects of orthoses on patients with knee instability following spinal cord injury (194 patients). Two of the studies64,67 were conducted in the UK. There was one RCT of 10 participants53 and two controlled trials66,67 and the remainder were case series. 57,59,62,64,65,68 Five studies53,57,64,65,68 had 20 or fewer patients. In five studies57,64,65,67,68 it was unclear if the sample was representative of patients seen in practice. In one study53 patients were chosen based on their motivation to walk.

All the studies investigated types of HKAFO. Three studies53,59,68 investigated the Walkabout^® (Polymedic, QLD, Australia) orthosis (WO), a HGO. Harvey et al. 53 compared the WO with an ISOCENTRIC^® RGO (Centre for Orthotics Design, Campbell, CA, USA) used by the same patients. A randomised crossover design was used with a 3-month home trial period and a 2-month washout period of no orthoses use, although the data were analysed as though from a parallel trial. Two studies59,68 had no comparator group.

Two UK studies64,67 investigated the ParaWalker, a HGO. Summers et al. 64 had no comparator group and Whittle et al. 67 compared the HGO to a custom-made RGO worn by the same patients in a crossover study.

The remaining four studies57,62,65,66 investigated types of RGO. Two of these studies57,65 had no comparator group. Scivoletto et al. 62 compared patients using a RGO to those patients not using it, and Tang et al. 66 compared three different types of orthoses (plus rehabilitation training) to rehabilitation training.

All nine studies53,57,59,62,64–68 used patient-reported outcomes, specifically functionality of the device (Table 12). Five53,57,59,64,67 studies reported measures of patient satisfaction, one study66 reported quality of life and five studies53,57,59,62,64 reported usage of the device. There were fewer objective assessments across the studies. Four studies53,65,67,68 made a formal assessment of walking ability. Resource utilisation data were limited to assessment of device malfunction in four studies57,59,64,67 and cost in one study. 67 Six studies53,59,62,66–68 failed to reported adverse effects data or to mention that no adverse effects were identified. This section is grouped by orthotic device.

Sample characteristics

Twenty-four people were recruited into the study. Nineteen patients were recruited across the three NHS sites; five patients were recruited in site 1 (P1, P2, P4, P13, P17); five in site 2 (P10, P11, P12, P20, P21); and nine patients were recruited in site 3 (P3, P5, P6, P7, P8, P9, P19, P23, P24). The five people recruited outwith the NHS (P14, P15, P16, P18, P22) were located across different areas of England. Of the total sample, 12 people had been diagnosed as having poliomyelitis; five people said they had multiple sclerosis; two people had CMT disease; three people had experienced spinal injury; one person had a diagnosis of spina bifida; and one participant had experienced a stroke. Participants’ ages ranged from 36 years to 80 years, and the median age was 64.5 years. Half of the study participants were engaged in either full- or part-time paid employment, whereas the other half described themselves as retired. Three-quarters of those interviewed said that they lived with their spouse and/or other family members. Details of the study sample are given in Appendix 13.

Findings from the qualitative study are reported under the following subheadings:

1. impact of NMD and CNS conditions on walking and mobility

2. use of orthotic devices

3. wearing orthotic devices

4. use of mobility aids

5. fitting/acquisition of orthotic devices

6. how use of orthotic devices (KAFOs, AFOs, knee braces) may impact on skin

7. positive and negative aspects of orthotic devices

8. appearance connected to orthoses

9. footwear

10. desired treatment goals and outcomes

11. care pathways and factors that impact on experiences of care

12. interactions with HCPs.

Impact of neuromuscular disease and central nervous system conditions on walking and mobility

Study participants reported a range of symptoms and sequelae associated with neuromuscular and CNS conditions that limited their ability to walk and mobilise as they might wish. They described experiencing pain (sometimes severe) in the knee or ankle joints; hyperextension of the knee joint; muscle weakness in the lower limb and/or of the muscles supporting joints; limbs of unequal length; having feet that are ‘frozen’ in an abnormal position; varying degrees of paralysis in lower limbs and feet; toes that are ‘curling’ inwards; and drop foot. Participants described resultant difficulties associated with walking and mobility: frequent falls, often preceded by a feeling that their leg was about to ‘give way’ under them; loss of sense of balance and stability; a ‘lop-sided’ gait; dragging their feet; constantly tripping, especially on uneven surfaces; difficulty standing for any length of time or walking for any but short distances; and fatigue, as well as wear and tear in their ‘good’ or unaffected limb due to transfer of weight and effort in walking.

I went, I am in pain, and then he examined me and goes, of course, it’s not normal, your body is lop-sided.

P1

I am very good at falling over . . . it’s because my muscles are so bad [weak] and you need lots of muscles to hold you up straight.

P18

I fall all the time because my knee can give way . . . sometimes it’s very serious falls and sometimes it’s minor falls.

P1

My knee giving way, like the muscles suddenly weakened . . . as I was picking up heavy things, my legs felt weak . . . I am used to them crumbling underneath me and sometimes I catch myself from falling.

P7

I started to take some heavy falls because my one leg kept giving way underneath me and it was then that they decided, well hang on a minute, you know, you’ve got some form of instability of not walking properly and I was forever going over on my ankles because I’ve got weak ankles and it was then that I started to go see somebody about getting some orthotics fitted.

P22

I wouldn’t be picking my feet up properly and I would trip and go full length.

P2

I can walk about but I have to keep sitting down and have a bit of a rest and I can’t, you know, stand talking to somebody, you think, oh, I’ve got to sit down.

P11

It was just my right knee that got a lot of wear and tear because the right leg is less straight than the left, and that’s the one that’s been bearing the brunt of not walking very well.

P2

Participants also commented on psychosocial impacts arising from their experiences of chronic pain and impaired ability to walk and be fully mobile. They expressed feelings of fearfulness and anxiety about falling which, in turn, led to diminished self-confidence and independence.

The last time I was on the tube I got pushed, literally, and I lack confidence and get scared, so if I haven’t got somebody with me, I won’t use the tube.

P23

Usually when I go out of the house always my partner has walked at the back of me, always, and he needs a medal.

P4

A number of participants expressed concerns about their future ability to carry on driving, or working, with implications for becoming dependent on others. Deterioration of their neuromuscular condition, leading to possible further impairment in the future, was a pre-occupying concern of almost everyone interviewed.

I used to be able to go there quite quickly . . . I used to work for this mobile crèche and I used to get on trains confidently . . . but I can’t do that now.

P7

I was . . . in a very well paid job and of course one of the main things of Charcot–Marie–Tooth does, not only does it affect your walking but it also affects your hands and it affects your dexterity. Well as an electronics engineer that was the one thing that I actually depended on was my hands and my dexterity and of course I had to stop work . . . and so what am I going to do now for the rest of my life because, you know, I’ve still got a long working career in front of me . . . my condition has got worse as I’ve got older.

P22

I am concerned that the knee is going to get worse. I’m 64, not desperately old yet. You know in 10 years’ time, it’s not going to be good. I can feel that it’s changing, my leg is changing shape. My foot now sticks out at an angle and my knee goes it, so it is all sort of collapsing a bit really. The knee definitely needs support.

P14

A few respondents revealed feeling socially isolated from friends while others expressed feelings of regret that they were unable to pursue activities they once enjoyed.

Because obviously I walk slower so I am on my own quite a bit because I have got good friends who will walk with me but a lot of people [won’t] . . . so it does actually make you an alone sort of person because society doesn’t really accommodate, it’s intolerant of people who have a lot of weaknesses . . . people who have never had that problem just don’t understand.

P2

We used to go to [place name] a lot but the last couple of years we haven’t because you have to go up the side steps . . . when it started to get a bit difficult for walking.

Husband of P13

Many of the people interviewed indicated that they were proactive in pursuing preventative measures to postpone and/or abate the impact of future deterioration related to their neuromuscular condition on their ability to mobilise independently. These measures included keeping their weight under control; exercising to maintain or enhance general levels of fitness through, for example, regular walking or swimming; and undertaking exercise regimens recommended by NHS or private physiotherapists.

I am going to have problems later on and I want to keep independent, if I could prolong independence . . .

P15

I saw how much I deteriorated in the last 5 years you know . . . I try to help myself, I am trying, like with my weight for example, I have to work on that and my exercise . . . I am active.

P22

I’ve been referred to a physio . . . I was also sent for some hydrotherapy treatments . . . but I mean I used to go swimming anyway but I don’t any more because I find it’s too difficult to get in and out of the pool and I’ve lost a lot of upper body strength as well over the last 2 years, so swimming I now find very difficult . . . basically it’s down to me to monitor my condition and then if I think I need to do something about it then I’ll go and see my GP and then my GP points me in the area of where I need to go.

P22

None of the 19 study participants recruited via the NHS reported belonging to a patient support group, whereas four out of the five participants recruited outside the NHS were recruited via patient support groups, including British Polio Fellowship and Charcot–Marie–Tooth UK. (The fifth non-NHS recruited participant had read about the study on the dedicated web page and made contact with the study team.) The benefits of support groups cited were related to obtaining information and gaining mutual support from people with similar experiences.

People say, oh, I’ve tried this and I’ve done that and you can get information from people and it’s just being around people with the same condition because when I first got diagnosed with this [CMT] I felt very isolated . . . the reaction from medical staff was ‘what the hell is that?’.

P22

Of the 12 participants who had a diagnosis of poliomyelitis, four (P15, P16, P18 and P23) spoke (unprompted) about their concerns about future deterioration linked to post-polio syndrome, although P15 and P18 commented that they had encountered scepticism among HCPs about this diagnosis. These four interviewees were anxious about muscle wasting in their upper body, arms and hands, and associated potential impacts on their functional ability. P16 revealed his reservations about advice from physiotherapists because of his perception that non-expert advice could result in further damage.

Somebody told me that there’s a neurological physiotherapy department at [name of hospital] you know, sort of cut above the rest as it were and my quack referred me and I went along really quite apprehensive to talk to them about what they were planning on doing because I didn’t really want to be damaged and the problem with multiplex polio is exercise makes it worse rather than better. Exercise will improve your suppleness and what have you but if you start working the muscles too hard, you further damage the validity and quite a few people with polio ended up sort of worse off through having physiotherapy.

P16

Obtaining the ‘right’ orthotic device(s) to help with current and future mobility was, understandably, a central concern of all those interviewed for the study. Participants’ perceptions of the desirable features of a suitable orthotic device (or devices) will be discussed in the body of the report below.

Use of orthotic devices

The orthotic devices that patients reported that they had received varied according to their diagnosis and their individual needs. Generally speaking, patients who had been diagnosed with poliomyelitis had received KAFOs, which they frequently referred to as ‘callipers’; these had mainly been obtained though NHS orthotic services, although two people had sought devices through private suppliers, and others were considering doing so. Most of these people had more than one device. Some were in the process of being fitted for a new KAFO and were also using their ‘old’ device while they were, in their words, ’breaking the new one in’.

Some differentiated between KAFOs that they used for indoor and outdoor wear; most people were very keen to retain at least one ‘spare’ KAFO that they could fall back on in the event of breakage or need for repair of a newer device. Three people with a diagnosis of multiple sclerosis reported having been given an AFO, as did the two respondents with CMT disease. The study participants with spinal injury and the one patient with a diagnosis of stroke reported using knee braces and inserts in their shoes, which had been fitted and provided through NHS orthotics services. We also asked patients about other aids to mobility that they use, and participants reported using these aids in combination with, or sometimes, instead of, the orthotic device with which they had been issued. Table 13 lists the devices and/or aids that they said they had received or were using at time of their interview.

Wearing orthotic devices

Participants’ reports of the wearing of their orthotic devices ranged along a continuum from ‘full-time’ (daytime) use to non-use of issued devices. Some people (P3, P5, P6, P7, P19 and P23) reported that their device is essential for them to be able to mobilise independently and, consequently, they said that they would wear it for all daily activities, including at work, using public transport, and participating in social events and gatherings.

Other participants reported partial use of their device for a variety of reasons: some (e.g. P21) said that they might use their device(s) outdoors, but that they could manage to move around inside their own home without it, sometimes by holding on to furniture, as reported by P13. Other participants reported wearing their device only intermittently because they were ‘breaking in’ a new device (P6, P14); because they felt that they did not always need the support of the device, only on ‘bad’ days (P20); or because of discomfort (P18). P18, for example, commented that she benefited from using her KAFO for walking, but found it uncomfortable when she was seated as it ‘stops the circulation’.

Participant 13, with a diagnosis of multiple sclerosis, commented on a (KAFO) device that had been proposed to her in the past; she had given it a week-long trial but had rejected it because she could not operate the locking mechanism because of a lack of muscle power in her hands. Her husband appeared angry and frustrated that she had not been offered a more suitable alternative.

She [orthotist] told us to try it . . . it didn’t work because that’s what you’ve got to do, lock and unlock it . . . we had our hopes for that calliper thing . . . until we found out what we had to do with it.

P13’s husband

Participant 1 was the only person interviewed who responded that she was not wearing the provided orthoses at all; during her interview, she retrieved her KAFO from another room in the house, still in its plastic wrapper, and said that she preferred to rely on a stick for assistance with mobilising.

Most people who relied on a KAFO indicated that they viewed it as essential to hang on to their ‘old’ device during and after fitting of a new one, and some people appeared reluctant to make the transition to a new device, which could pose challenges to them in having to work through a period of teething troubles and possibly have to adjust their gait to some extent. They revealed that they would choose to wear the ‘old’ device for specific activities. For example, P15 had purchased a new, high-tech device from a private supplier and was trying to become accustomed to it at the time of interview; she commented that although she was endeavouring to use her new device for increasing periods of time, she relied on her ‘old’ calliper for her daily walking, which was extensive (up to 8 miles per day) and which she regarded as essential for her physical and mental health.

Interestingly, some participants commented that they did not use their devices all the time because they wanted to try to remain as mobile as possible without it and feared becoming totally reliant on their device.

I feel that if I completely rely on it I won’t be able to do without it.

P18

Use of mobility aids

Most of the people interviewed indicated that in addition to (or sometimes instead of) their orthotic device, they made use of mobility aids, such as sticks and crutches, wheelchairs and mobility scooters.

People commented that using one or two sticks afforded them extra confidence with balance and stability, particularly when walking outdoors, and more so if the ground is icy or slippy. Participants also commented that a stick could help with transfer and distribution of body weight, a strategy that they used to assist with pain management in their knee joint. P23, like many of those interviewed, had purchased a stick himself, without any form of assessment or measurement, and he commented that he was experiencing pain in his arm on the side that he used the stick; he thought that he should really be using two sticks all of the time to achieve a more even transfer of body weight, but was reluctant to have to rely on two sticks for walking, in addition to his KAFO, because he would have to recognise and come to terms with the continuing deterioration in his condition.

I’m at the stage now where I need two sticks to walk. If I want to go for a walk in the park, I take the two sticks with me and it’s so much easier, so much easier because I compensate a lot for my balance and I don’t realise how much effort I am putting, how much pressure I am putting . . .

P23

Some participants (P8, P16 and P17) stated that they needed to use crutches in addition to their orthotic device for walking even short distances. Crutches were also reported as being used for getting up in the night to go to the toilet, or when relaxing at home after work, after taking off the KAFO device, or for ‘popping’ out to local shops, when the sustained support from the KAFO was not needed. However, one participant commented that she had found it difficult to obtain comfortably fitting crutches.

I mean even my elbow crutches, they don’t make these elbow crutches to fit me any more, so I spent another two or three years chasing round the services to get these commissioned because the Health Service en masse provide the adjustable ones but they’re too long for me here. They don’t come small enough here for me because of my physique.

P19

Views about wheelchair use were polarised across the sample. For some people, combining the use of a wheelchair along with wearing of their orthotic device represented freedom and independence, for example to cover long distances, much further than they could walk, to travel abroad for work or leisure and to carry out activities (such as visiting shopping malls or supermarkets, or a Christmas fair) that would otherwise be denied them. P5 described ‘whizzing around’ in his electrically powered wheelchair, which he had purchased through an Access to Work scheme.

Qualities sought in a wheelchair were that it should be light (for easy transfer in and out of a car) and preferably not too large, so that it could easily be accommodated in the home. Some study participants who relied heavily on a wheelchair, such as P16, commented that they had one wheelchair for indoor use and one for outdoors, one of which had been supplied by the NHS and the other purchased privately. P19, who owned a manually operated wheelchair, commented that she has bought a hoist, at her own expense, in order to be able to load it into and out of her car without assistance.

Two study participants (P4 and P10) described their reluctance to use a wheelchair, although both felt that the benefits outweighed the drawbacks. P4 did not like the stares she attracted when out in her wheelchair. P10 said that she had avoided using a wheelchair for as long as possible but, as her condition deteriorated, she had had to accept that she could benefit from using one; when interviewed, she was planning to take her wheelchair with her on an overseas trip to see a close family member, and she also recounted how using her wheelchair enabled her to go out on day trips with friends.

Participants 1 and 2 viewed wheelchairs as anathema: P2 described having to use a wheelchair as her ‘worst fear’, whereas P1 said that she felt pity for people in wheelchairs because ‘they’re like thrown away, lost causes’.

The advantages of disability scooters cited by participants were similar to those of wheelchairs; P18 said that she had a disability scooter for ‘getting around’ and a ‘luggie’, a small disability scooter that was useful for travel as it could be folded up for taking on an aeroplane. P12 said that he had resisted buying a mobility scooter for a long time, but then saw one in action at a festival and realised how useful a scooter could be; for instance, it facilitated independent mobility without the need to have someone else to push the scooter.

Fitting/acquisition of orthotic devices

How use of orthotic devices (knee–ankle–foot orthosis, ankle–foot orthosis, knee brace) may impact on skin

Most of those interviewed said that they were not experiencing ill effects on their skin due to wearing a KAFO or AFO, in part seemingly due to measures that they themselves took to prevent skin damage, such as wearing tights or leggings or pyjamas under the device to protect the skin, adding extra padding at ‘pressure points’ or, in one case, (P9) buying his own ankle straps, made of softer leather than those that were supplied. One participant (P16) stated that he had worn devices made from plastic in the past, which had resulted in skin rashes, and he expressed a preference for callipers that were made from metal and leather because he thought that devices made from carbon fibre would cause problems similar to those made of plastic.

Wearing the device in summer if the weather is warm was associated with discomfort and some participants referred to the pleasure of being able to take the device off at the end of the day, to allow their skin to ‘breathe’.

During the summer I quite often wear pyjama bottoms underneath the straps and leather of the calliper . . . they have to be cotton and easily washable.

P9

One year I was on holiday and it was very hot, very hot and I didn’t have any tights on and, oh, it just rubs your skin, you can’t wear it against the skin. I had blisters . . .

P18

It’s a bit like taking your shoes off . . . when I take the calliper off the skin can breathe a bit more.

P3

Skin damage was mainly associated with newly acquired and/or ill-fitting devices, when some people said that they might expect some ‘marking’ or ‘bruising’ at pressure points, such as where the knee is in close proximity to the joint on the KAFO. P4 commented that she had received an ill-fitting knee brace after her stroke, and suggested that this had caused her to develop bruising. P21 reported padding out her AFO to protect the skin on her shin after receiving a new device, and expressed concern about wearing her newly issued device, specifically because of her anxiety about possible skin damage. In the past, she had suffered an open sore associated with her device, for which she had needed to seek treatment from podiatry services. P16 was the only person interviewed who described experiencing a long-standing leg ulcer during the time that he has been wearing a KAFO. The cause of his leg ulcer had apparently not been established, but P16 described a difficult period of non-healing of the ulcer, with frequent recurrence, despite intensive treatment in a specialist clinic. He suggested that non-healing of the ulcer may have been protracted by friction from his device.

They [ulcers] kept forming and they thought they’d cleared but all they were doing was getting them to heal over but there was still rot inside, the thing seemed to be caused by either pressure or something on the side of the ankle from my boots, so the orthotist built the boots out and then put different types of pads in . . . foam pads on and things like this. None of them stopped the reoccurrence and I guessed that what was happening was we were getting sheer forces from the action of the calliper and the boot because as you stand and put weight on one leg with a calliper, inevitably you get a sort of piston effect of your leg within the calliper . . .

P16

Positive and negative aspects of orthotic devices

Negative aspects of devices

Negative aspects of devices highlighted by study participants included devices that they judged to be ineffective; ill-fitting (causing pain, discomfort or skin damage); unreliable; uncomfortable; heavy, bulky or cumbersome; aesthetically displeasing; damaging to clothing and/or footwear; difficult to put on or take off; susceptible to breakage; and/or requiring high maintenance in the form of frequent repairs and readjustments (see Figure 2). When negative aspects of a device were perceived to outweigh positive ones, participants indicated limited or non-wearing of the device.

Of the total 24 participants interviewed, P1, with a diagnosis of poliomyelitis, expressed the most extreme negative feelings towards the orthotic devices that she had received. P1 reported that she was not wearing the KAFO and AFO that had been supplied for her, preferring to mobilise with the use of a stick. This participant, a woman in her thirties, works to support her family in an occupation requiring her to be physically mobile and able to stand for long periods of time during the working day. Her disappointment with the devices she had received became very apparent as the interview proceeded. The Velcro fastenings on her KAFO did not hold it in place, making it unwearable. She felt the devices supplied for her were a ‘complete waste of NHS money’ and that the orthotist had not listened to her when she was describing her problems and needs. P1 said that she had stopped attending appointments with local orthotics services, although was waiting to be referred to a different orthotist after a visit to a rehabilitation consultant. P1’s disappointment and frustration are reflected in the following quotations.

Ankle–foot orthosis

Perceived as ineffective

It’s supposed to help my ankle.

Causing pain and discomfort

It was cutting me and the shoe . . .

Damage to footwear

The ankle one, I’ve given up on it because to be honest, it’s ruined my shoes.

I put it inside my boot, which it has ripped my boot and damaged them.

Knee–ankle–foot orthosis

Perceived as not secure

This [brace] is for my knee . . . this doesn’t stay on my knee, as I am walking it falls right to the bottom . . . it doesn’t even stay on my leg.

Can you imagine, as I am walking it’s slipping down.

Perceived as ineffective

If it worked, it would be OK . . . there’s no benefit in it.

It just doesn’t do nothing . . . I swear, I feel completely hopeless.

Difficulty in putting devices on

These items are becoming like a toy . . . like a jigsaw puzzle that I’m having to deal with. I have to put my knee on, then I have to put my leg on before I can put my shoe on, and I still have to use my walking stick by the way with these on.

Non-wearing of device

I’m not going to lie or say I wear it, it’s just sat in the bag looking pretty.

Frustration with orthotic service

The last appointment I didn’t even know, because I didn’t go, because I was just like, I’m wasting my time . . . I just cancelled it.

Doctor [name] took a picture of them . . . he put them up on his table and took a picture of them and laughed, he couldn’t believe it . . . the device they gave me.

Male and female participants reported having to restrict their choice of clothing and/or footwear to accommodate their devices, as well as damage to clothing that caused inconvenience and expense. In particular, it was reported that fabric would be damaged when it comes into contact with the joint of a device. Male participants commented that they were restricted in their choice of trousers, which could prevent them from being able to appear smartly dressed on formal business or social occasions.

All callipers are not great in terms of heat in summer and in hot weather you’ve got plastic and metal against your skin, and you have to wear socks and boots in August . . .

P6, female

You get ladders quite a lot [in tights] . . . my tights aren’t 50 pence a pack . . . you’re going through them very rapidly . . . Velcro snags very easily . . .

P19, female

The other thing that callipers do, if you get quite expensive trousers, they tear them up and just rip, you know, even linen or wool trousers, they will just tear . . .

P6, female

Two wears and the trousers are gone . . . it’s really annoying, I can’t buy decent trousers.

P23, male

I don’t wear super tight jeans!

P9, male

It’s difficult to get trousers that are really wide . . . so I buy women’s jeans . . . from second-hand shops, the charity shops . . . callipers damage them, I can’t pay £50–70.

P16, male

It’s really annoying, I can’t buy decent trousers.

P23, male

Issues concerning footwear were commonly reported by participants in relation to their orthotic devices, and will be discussed in more depth below. Some participants experienced difficulties and discomfort when trying to accommodate a new device with their existing footwear; some said the orthosis caused shoes to wear out more quickly, whereas others appeared reluctant to exchange their usual footwear for new footwear that would more easily accommodate a new device.

Getting a shoe on with my [new] calliper is very difficult . . . I mean it’s not very comfortable in the shoes that I’ve got because they’re not purpose built for the device.

P14

You just can’t get in most of the shoes and it’s very bulky because of this strap going round your ankle . . . you’ve got to be wearing the right shoes . . . you couldn’t really wear the shoes I’ve got on now, or my work shoes. You’ve really got to wear outdoor shoes that are very wide . . . in fact we only managed to get it in one very, very big pair of trainers . . . and I just said straightaway, I’m never going to be able to wear this, it was just horrible, very, very impractical.

P12, discussing an AFO supplied to him but which was not used

I buy [brand name] shoes because they are a bit more sturdy but even then they might only last 6 months. Most of them really should last 2–3 years, so that is a cost.

P3

The look and feel of the orthotic device appeared important to both male and female participants, with the ideal suggested being a lightweight, sleek, discreet device. However, some participants reported having devices which they found heavy and cumbersome.

It was a big clunky piece of machinery . . . the whole thing was just too clunky. It was substantially heavier and almost cruder.

P9

I’m not really getting on with it [new KAFO] . . . it is such a cumbersome, difficult thing.

P14

Several participants expressed a wish to obtain devices that are more technologically advanced than the ones they currently had.

I don’t know if they’ve got electronic knee devices now that I can stand up without having to hand lock it . . . I’ve been wearing this for years and years. Technology has been zero on it, absolutely zero . . . I mean there are so many new materials available, I am sure they could use titanium, all kinds of other materials.

P23

A dislike of Velcro fastenings was expressed by number of those interviewed, the main reasons cited being that Velcro did not hold the device securely in place, or that it ‘snags’ on tights, and collects fabric fibres and fluff, making it ineffective; one participant (P16) said he disliked Velcro fastenings because they could not be quietly adjusted, for instance, during a meeting.

I have buckles, I hate Velcro . . . you can’t adjust it quietly so if you’re in a meeting or something and it’s too tight . . .

P16

The aspects of devices that were considered highly negative by participants, and significantly concerning, were the likelihood of a device to fail in some way and a need for frequent repair and/or readjustment. Both had the potential to have a hugely negative impact on patients’ confidence, ability to be mobile and get on with their daily lives. The breakage of a device was viewed as a crisis. Participants suggested that there might be a potential trade-off between the lightness and elegance of a device, and its durability. Some people questioned the quality of various components used in the manufacture of devices, suggesting that, for reasons of cost, the most effective or enduring components might not be routinely used. Comments on the functioning of rivets and hinges in KAFO devices were frequent. Participants provided vivid accounts of specific incidents when a device malfunctioned in some way, especially concerning if it happened when they were travelling abroad. Fear of failure of a device seemed to be the major underlying reason for participants repeatedly commenting on the importance of having a spare device that could be used as a replacement while the new model was being repaired.

if it breaks, you’re kind of thrown really . . . I came out of work, it was about half past six, and I got across the road and the calliper just went, it just snapped, it was one of those carbon fibres . . .

P6

As soon as this thing breaks down, I’m in silly street . . . that’s not a place I want to go.

P19

I would say the source of failure now, as opposed to the wear and tear, is the hinges, you need reliability in the hinges . . . this is one of the problems with this kit [device] . . . one of the hinges just failed without warning. So that’s an immediate demobilisation . . . so in the normal course of circumstances if you didn’t have a spare to hand, which I didn’t when I was away . . . one of the problems is how do you get that emergency repair effected immediately?

P8

Let’s assume that the strongest rivets are stainless steel rivets, well I was saying, well why don’t you use the stronger rivets to begin with. It’s almost as if they’ve got three levels of rivet, a bronze, silver and gold and you start with the bronze and they say, oh they’re not surprised that went and then they take you to silver and you almost say, well let’s assume that the gold variety of rivets was stainless steel, let’s assume, it may cost a few quid extra but it would make a huge difference because it holds the whole thing together really.

P5

When I had this one, I found that the rivets on it broke but these have been replaced but I always worry that these will go as well because they’ve been going and I’ve been told that there are two or three different types of rivets and I think it’s more when you’re twisting on the leg, it creates a torsion whereby the rivets after one or two pop it creates almost like a quick mechanism for the rest of them to go really. So that’s been an issue really.

P5

I get the knee joints failing which is terrifying because you go flying across the room on a good day and hit the floor on a bad day and you’ve completely lost confidence in that calliper then.

P16

Last year we went to [American city] and literally, literally we’d just landed at [ ] airport and I’m walking to get my suitcase and I fell flat on my face . . . what happened this, the thingy here, see there, it just went. Really is this screw holding me, I mean can’t you think of something stronger than that! That’s what I’m saying . . . the whole thing is very basic. All these should have been tightened up. Another time, the same thing here, the thing that they solder in the middle, the solder went, so that slipped out and again . . . the most unhelpful place on earth, [ ] airport, but yeah the holiday was ruined because I could walk but I had to do everything by hand and I sort of held it with thread and things. I couldn’t relax, you know, it was a short trip.

P23

Even a seemingly relatively simple procedure, such as having leather straps replaced when they wear out, could cause difficulties and inconvenience for device users.

The knee strap by virtue of the fact that it’s made of leather will after a while stretch, there’s no getting around that. So last time I had one replaced, I took it in and it got replaced and it was sent back out to me, but actually someone had put it on back to front . . . so I had to take it back.

P19

Participant 15 reported on negative aspects of the device that she had procured from a private supplier (a stance control model) including that it is adapted for walking only on level ground, which left her feeling frightened of walking downhill with it on. She said that she had to concentrate hard on thinking about walking while wearing it, as it seemed to require different walking patterns from her usual ones; she added that she had experienced a bad fall while wearing the device, resulting in damage to ligaments.

Participants’ perceptions of the negative and positive aspects of their orthoses are summarised in Figure 2.

FIGURE 2.

Study participants’ perceptions of positive and negative aspects of their orthoses.

Appearance connected to orthoses

For many people, appearance of their device seemed less important than other aspects, such as reliability and comfort, which they said they valued more.

Given the choice of a bad-looking orthotic appliance compared to one that is snazzy, obviously everybody would like a smart looking one but to me that’s not the be all and end all. I’m looking for reliability that’s the most important thing to me and one that doesn’t need a lot of repair.

P3

I’ve got to an age now accepting that I’ve got to be comfortable.

P2

Most of the women included in the study commented that they tended to choose to wear trousers, in part to conceal their device, as well as for more practical reasons. P18, a woman in her early seventies, commented that she ‘detests’ wearing her device, always wearing long skirts or trousers to hide it.

It’s a little bit of vanity as regards wearing something on top.

P4

It is horrible, really horrible to wear. I hate it. I detest it with a passion. When I wear it I always wear really long skirts to hide it or trousers.

P18

The desire to appear as ‘normal’ as possible when wearing an orthosis was expressed by both male and female participants. Among the men included in the study, P12 displayed strongly felt views on the importance of appearance in relation to wearing a device and he suggested that clinicians ought to pay it more attention. P12 commented that he did not want to have a device that made him look or feel ‘trussed up like a turkey’.

I think the appearance, I would always want to look normal as possible . . . and maybe other people don’t notice that you’ve got it on sort of thing.

P12

Orthotics a long, long time ago said that I ought to look at having something and it was something that went right down to my toes and virtually up to just below my knee and . . . you needed two or three sizes bigger shoe. In fact I think we only managed to get it in one pair of shoes and that was a very big pair of trainers and I said straightaway, well I’m never actually going to be able to ever wear this. It was just horrible, very, very impractical. I’m not even sure why they actually gave it me at the time.

P12

If it was left to them you’d be trussed up with, you know, yes things that make you walk absolutely great but you’d look like a clown in the street sort of thing rather than thinking now what would make you look normal, that’s really what I mean. They work on thinking they’ve got to make device as effective as possible to get over the disability and blow the what it looks like whereas I think you’ve got to have a bit of a compromise at times, that’s what I would say.

P12

A number of participants expressed the wish for uniform colouring of their KAFO, and for the last few inches of a device (towards the ankle) to be in a colour which matched their skin tone. This was underlined by P5 (male) and P19 (female) who pointed out that they regarded their device as an extension of themselves, integral to their identity. P19 stated that ‘the cosmesis is really important to me otherwise we are back in the dark ages’.

Why have we got the blue leather with the flesh colour . . . I don’t get it . . . why have we got flesh colour leather if we’re going to put the blue/grey round the outside? . . . actually this is how I present to the world and it’s very important to me . . . I refuse to be Polly Patchwork . . .

P19

So I was thinking, oh I’ve seen prostheses with various skin colour and they do whatever it is the fibreglass with different colours and I’m thinking why isn’t that given as a possibility in terms of different types of skin colour when you’re sort of wearing it and things, just where you feel, it’s an extension of your own leg but sort of it’s part of you in a way.

P5

Participants reported that they could feel conspicuous when their orthosis was visible to other people because of the stares they could attract; some people mentioned feeling discouraged from going to the gym or swimming pool because they could feel people looking at them, or because they sensed the discomfort of the people around them. Other participants commented that they did not want to evoke feelings of pity in others, nor to feel stigmatised or concerned about their personal safety if they could be identified as ‘disabled’.

If I go to the gym, there is only one piece of equipment I can actually use but people don’t seem comfortable even about advising you . . .

P6

When I go on holiday there’s a pool and I can swim, you know, without an audience.

P23

You walk into a restaurant, and where are the eyes?

P4

I’m not trying to make people feel sorry for me . . . I don’t want nobody to pity me. I don’t want them to feel sorry for me. I want to get on with my life. I know I have got a disability but do I have to let the whole world know that I am disabled?

P1

Sometimes I wear shorts in summer but when people see me they act different to me . . . the fact they can see my calliper.

P3

People can come up to you and you never know when, any kind of disability can trigger you know, nice and not so nice behaviour and so I suppose in a way even though like covering it up, you know, you are identified as disabled, it feels a bit more safer . . .

P6

A few male participants downplayed the importance of the visibility of their orthotic device. P8 suggested that he was quite uninhibited about wearing his device with shorts and a tee shirt when on holiday abroad. By way of contrast, he recounted how the ‘invisibility’ of a device was important to a business man who, he had heard, had sought a discreet, high-tech device that he could conceal from view.

It’s easy for a man, you just stick [the orthosis] in your trousers and nobody notices it when you are walking about.

P11

I’m in my Bermuda shorts . . . so I wear my undercarriage [device], training shoes and a tee shirt, so there was good visibility of the undercarriage and I went for a walk through town, I was comfortable, I wasn’t the slightest bit bothered at all.

P8

This Aston Martin carbon fibre device built for this business man, he wanted its actual existence to be invisible . . . he had a strap that came into his pocket in his bespoke design suits and he just puts his hands in his pockets and click it and sit down as if it was a normal leg . . . he doesn’t want people to know.

P8

Footwear

People interviewed for the study referred to the footwear that they used with their orthoses by various terms, including shoes, boots, orthopaedic shoes and surgical shoes. People who used KAFOs and/or AFOs stated that they might be fitted for new shoes at the same time as being fitted for their orthosis in order to accommodate that particular device, whereas others said that they used their device with ‘normal’ shoes that they purchased themselves. Many respondents mentioned using orthotic devices, such as insoles and inserts, in their shoes; others described how each shoe of a pair might need to be of different width or height, depending on their individual needs.

Participants whose first preference was to wear ‘normal’ shoes seemed to accept that they might, or would, have to move to having their shoes supplied through orthotic services at some point in the future. A number of issues connected to footwear emerged as important to participants, namely the fit of the shoes; damage to skin/and or deeper tissue; repairs; number of pairs of shoes supplied to individuals; choice of colour or material; weight of shoes; level of comfort; absence of ‘grip’; and appearance (Figure 3).

FIGURE 3.

Study participants’ perceptions of positive and negative aspects of footwear.

A major priority identified by everyone spoken to was that shoes should fit well. Participants with a diagnosis of poliomyelitis commented that they can require shoes of different width and height for each of their feet. Some people commented that they needed to receive shoes via orthotic services to accommodate their orthotic devices. P14 had recently received her first KAFO device but was not wearing it because she was facing difficulties using the device with her ‘normal’ shoes, although she reported that the orthotist had advised her to try to manage with her usual footwear, at least initially.

Since I took possession of it [orthotic device] I’ve been back to see the orthotist twice and he said, well do try and get on with it, but he said, if you really can’t we’ll think about getting some shoes made. My foot is stuck in the equinus position so the calliper means I have trouble with shoes . . . my shoes don’t fit . . . I can’t get it in my shoes, it’s uncomfortable and it just seems easier not to use it, which is terrible really because I should be using it.

P14

The importance of having feet assessed and measured frequently, to detect any possible changes, was highlighted. For example, P5 stated that recently his toes had started to curl under his foot, rubbing against the leather on one of shoes, causing pain, and he said his shoe had started to feel too small; he thought he would require new shoes, as well as a possible intervention through podiatry services. Only two of the people interviewed mentioned experiencing difficulties in getting their feet measured. P9 commented that he had been ‘wearing the same type of shoe without a refit since 1970’ and his wife suggested he needed to have a new mould of his feet taken. P15, who said she had not had her feet measured for > 10 years, found that the shoes she was receiving were becoming increasingly ill-fitting, and that recently she had ‘insisted’ on having a review and having her feet measured:

I had to insist and say, look none of your shoes is fitting me properly . . . I haven’t had them reviewed since the 90s and I’m a lot older . . . every time I come, something is wrong.

P15

Almost all participants who wore shoes that were provided through orthotic services suggested that they were ‘entitled’ to a certain number of pairs of shoes a year, and most people thought that they could have up to two pairs of shoes at any one time, which allowed for one pair to be undergoing repairs while the other pair was being worn. Individuals reported different time frames for shoes to be provided and repairs to be effected.

Participants said that shoes required repair frequently, as heels and soles wore out quickly as a result of their particular gait. Long waiting times were said to be frustrating, and people could feel anxious having only one pair of shoes for everyday use. Some people reported that they had been told to expect shoes to be delivered by a particular date, and feeling disappointed when they were not available when promised. P23 said that he had hoped to pick up a pair of boots on the day before a job interview but they did not arrive, and he added that he had been waiting > 3 months to receive a new pair of boots. He suggested that provision of footwear would be improved if the people making the shoes were on the same site as those involved in provision of orthoses, so that their particular expertise is readily available.

I think personally, if the shoemakers were on-site it would make a big difference because [name of orthotist] has to relay to that person and that person has to relay to that person, it’s like too much. Well that thing could have been resolved in a second, you know.

P23

The convenience of delivery of new or repaired shoes to a home address was appreciated. P3, who works full-time, said that a pair of new shoes were waiting for him to collect, but that he would be unable to pick them up until his half-term holiday, whereas extended opening hours of the orthotics department would enable him to pick them up sooner.

Choice of colour, fastening (Velcro or lace-up), material (leather or suede) and style of shoes were deemed more or less important by everyone interviewed. Several people mentioned that they tended to choose black or brown shoes as they ‘go with anything’ and are particularly suitable for work or business, and a few people seemed to think these colours were the only ones on offer. One individual (P5) made a strong case for having a choice of brighter colours, saying that wearing brightly coloured shoes is one of the ways in which he expresses his personality.

Because of my personality, I like bright shoes, for example, I always wore bright green shoes . . . these are quite bright red really, you can only go for one of the five colours that are provided really . . . I would be happy to pay for it, it is part of your identity.

P5

Participant 16 said that, in his view, choices concerning durability, appearance and comfort of shoes would vary according to the purpose or occasion for which the shoes were wanted, and he stated that people should not feel ‘pressurised’ into having black or brown shoes.

If you want some boots for everyday work, durability and comfort are important things, and appearance comes lower down the list. If you are the bride’s mother, appearance is number 1, durability is zero because you are only going to wear them once and comfort doesn’t come into it either, but without that information, they [manufacturers] are not able to match what they are producing to the requests, demands, or expectations of the customer.

P16

Participants 1 and 2 suggested that comfort was more important than appearance, although they said they would prefer footwear that was discreet.

There is no point in weeping over kitten heels because I am never going to wear those. But something reasonably presentable, that is not too intrusive, because you’ve got enough to be getting on in life with without having some people staring at things you might be wearing because obviously I am a bit conscious of the way I do walk . . . and people do stare a bit, so something that can be quite discreet is important.

P2

A normal shoe, but built inside, so it’s normal . . . so you can’t tell no difference, but build inside . . . if you don’t want somebody to notice that you are wearing something or that you’re disabled.

P1

Many people expressed a dislike of ‘heavy, clumpy’ orthotic shoes because heavy shoes compromised the ease with which they could walk. P22 felt that features of orthotics shoes have improved substantially in recent years to great benefit, but he was less happy about having to be referred to the orthotic service each time by his GP when he required a new pair of shoes.

Well compared to the original ones, they’re a lot more comfortable, modern day orthotics now have come a long way especially in the last sort of five years you know. My shoes that they make me are sort of a quarter of the weight that they was when I first started having orthotics . . . it’s all right having these things to help you to walk but it’s the weight aspect. Because obviously the more weight you’ve got on, that causes problems in itself because of the weakness in your legs, you know.

P22

. . . each time I have to go back to my GP surgery for them to refer me back to orthotics . . . it’s quite a long-winded process . . . I can’t go straight to orthotics.

P22

Choice of fastening for shoes (Velcro or laces) was important to some people, whether to accommodate a particular device or for ease of use.

I always wore lace-ups because I always thought Velcro was for old ladies . . . and he’s a lovely orthotist, he actually ordered me a pair of lace-ups and Velcro so I could choose between them and when I actually used the Velcro I could see that if I look like an old lady, tough, that is what I wanted.

P10

I just choose something that’s easy for me to bend down and put on . . . just a Velcro to get on in a morning.

P7

She’d like to wear something different but she can’t.

Husband of P13

I can’t . . . I wear laces all the time . . . with ankle boots.

P13

Several participants mentioned that the grip on the soles of shoes supplied to them was often not very good, making them anxious about walking on muddy, icy or uneven surfaces, and it was suggested that a walking shoe type of sole could improve confidence with walking outdoors. Two female participants (P18 and P21) who were purchasing their own shoes, favoured a particular make of shoes for their width, allowing accommodation of their device, and their suppleness and comfort. P21 mentioned that she was advised by the orthotist to try this particular brand.

Well, I have [brand name] shoes . . . the [brand name] shoe is flexible enough, it’s got room enough and the [brand name] has an insole which can be taken out and then the calliper fits in.

P18

She told me to try [brand name] shoes because they do really wide fittings . . . I like my tie-ups because I can lift the tongue and slide my feet in . . .

P21

Desired treatment goals and outcomes

During their interviews, study participants were asked to identify their desired treatment goals and outcomes and their responses related to a range of physical and psychosocial factors that were deemed important.

Orthotic treatment that achieved effective support for the affected joint (the knee or ankle joint) was identified as the prime desired outcome, along with a reduction in the number of falls and/or trips experienced. Participants highly valued gaining, or maintaining, the ability to mobilise as independently as possible. Reduction of joint pain was identified as an important enabler of increased mobility. Freedom from having to worry that their joint might ‘give way’ was cited as an important treatment goal.

People associated an ability to mobilise confidently and safely with numerous benefits for their physical and mental health: increased self-esteem; possibilities for employment and assurance about financial security for themselves and their family; enjoyment of ‘ordinary’ family and social life; opportunities for travel; maintaining an interest in daily activities (e.g. gardening, days out with friends and family); and prevention of deterioration of their physical health or mental outlook, through being able to undertake regular exercise, such as swimming and walking.

Most of those interviewed seemed to have accepted that they were unlikely to ever be able to walk very fast or for very far, without a degree of fatigue, and they showed little interest in increasing the speed of their walking, or distance covered, as treatment goals per se.

Participants defined their own goals for mobility in terms of what they needed to achieve to enable them to lead their lives in the way that they wanted, as far as realistically possible, based on their own knowledge of themselves as individuals and the circumstances of their lives. P16 vividly described his own treatment goals in terms of being able to take just a few steps from his wheelchair, which allows him to engage in family life, something that was clearly of great importance to him.

My walking is so limited. If I can stand and get something out of a cupboard and walk a few steps and get back to the wheelchair or whatever, that’s what I can do, and that’s what I need to do. For example in [name] mother’s house I can’t get the wheelchair in . . . because of the threshold, so I have to get out, walk a couple of steps over the threshold and then get back in the wheelchair and to be able to just walk those few steps to stand is an enormous advantage. If I was paraplegic and couldn’t get out of the wheelchair, there is no way I could get into their house. Same as my son’s house in [place], they’ve just moved actually to one where hopefully we will be able to get in but that just been able to walk, you know, four or five steps is fantastic . . . There’s a bigger difference between me and a paraplegic than there is between [name] and I, you know, if you are paraplegic and cannot stand at all that is an incredibly limiting thing. The fact that I can’t walk more than a couple of steps isn’t that bad because I can zoom over in a wheelchair, so that is a tremendous advantage to me and I would be very reluctant to lose that ability . . . you can’t imagine how useful that is . . .

P16

Participants associated different activities with the prime treatment goal of enhanced independent mobility and attached varying degrees of importance to them.

I think the key outcome is independence actually . . . for me, it’s just having that freedom not having to worry that my leg is going to give way and I know it is stable and that I can stand for long periods of time . . .

P5

They [her orthoses] just give me a new lease, they give me my independence to go out on my own.

P21

I just do not want to become housebound, so that primarily is the objective of my orthotics.

P22

I need my surgical appliance to get on with my life . . . it needs to be effective and reliable . . . I want to be in the real world. I love it . . . I’m in a working world and I just want to get on with it . . .

P2

It’s just enabling me to keep going as long as possible which is really important to me.

P10

Walking is essential to him . . . to keep active as much as possible.

Wife of P9

Most respondents were prepared to accept and use mobility aids, in conjunction with their orthoses, in pursuit of independence.

In the last 3 or 4 months I’ve been to [name of place], [name of place] and on a family holiday to [name of place], so with the brace and wheelchair combined, it gives me total and utter freedom to do what I want really.

P5

If my legs get a bit funny sometimes, like I’m putting the washing on the line, I just sit in the self-propelling one [wheelchair] because I can move it myself.

P7

I’ve got a [brand name] mobility scooter and I’ve got a luggie which is a small mobility scooter which can be folded up and it can go in an aeroplane and I can go on holidays with that.

P18

Retaining the ability to carry on driving was regarded as vital to the majority of respondents as it allowed patients to pursue opportunities for to work and socialise, both identified as important for their mental well-being.

It’s very important having a car, I couldn’t do my job without a car . . . I try to go by train but by the time I get there, I am exhausted.

P3

I want to drive down and pick my mum up and bring her here.

P10

I’ve got an automatic car . . . I’ve got a mobility car with a hoist in the back which can pick up my scooter.

P18

Participant 2, like others, identified close monitoring of her condition with a view to preventing future deterioration as an important short and long-term treatment goal:

it is sort of critical . . . to know that I am under someone’s care and that I will be looked at and monitored and not just left until it flares up again, I want somebody keeping an eye on it now.

P2

Care pathway and factors that impact on experiences of care

The majority of factors cited by participants as impacting on their care pathway were mentioned by individuals across all three research sites, as well as by people recruited via non-NHS support groups. These generalised perceptions will be discussed with reference to specific research sites where warranted. Details of the research site will be included in attribution of quotation to specific individuals.

Interactions with health-care professionals

Response and completion rates

The survey was circulated to members of BAPO (n = 700), ACPIN (n = 2700) and BSRM (n = 300). A total of 238 HCPs agreed to participate in the survey, that is, they clicked into the survey questionnaire via the link in the invitation letter. Based on the sampling frame described above, this equates to a response rate of 6.43%. The response rate by organisation was 12% for BAPO, 3.48% for ACPIN and 16.67% for BSRM. These response rates are an underestimate as a result of the imprecise sampling frame. For example, information supplied by BAPO suggests that approximately three-quarters of their membership are orthotists, not all of whom manage patients with NMD or CNS conditions, leaving a more likely sampling frame of < 400. Similarly, not all participants in the sampling frame for ACPIN and BAPO manage the populations of interest.

The overall completion rate [the number of participants who finished the survey (n = 138)/the number who agreed to participate (n = 238)] was 57.98%; 68% for orthotists, 62.8% for physiotherapists and 54% for doctors in rehabilitation medicine.

The response rate was also calculated for each question in the survey. The denominator used was the number eligible to complete a specific question. As the survey hid certain questions from certain respondents (e.g. all questions that are specifically related to patients with a CNS condition were not asked of respondents who indicated that they did not treat patients with a CNS condition), the denominator varies across questions and across professions. The denominator used ranged from a maximum of 238 for the questions that all participants were eligible to complete to a minimum of 115 when only respondents who fitted devices could respond to a specific question.

The total number of respondents was well above the estimated minimum sample size required, based on a 95% confidence level and a 10% margin of error (n = 96), but insufficient for the more ideal 5% margin of error (n = 384). It was, therefore, not appropriate to undertake subgroup analyses. Descriptive results are presented by HCP as well as the total group; however, any apparent differences should be interpreted with caution.

For each question, the number of responses to each answer option is reported, and the proportion is calculated using the number of respondents who answered that particular question as the denominator. For completeness, the number of non-responders for each question was also reported. This ensured that the proportions of the responses presented were not overestimated. In the tables the total number in the all respondents column is greater than the sum of the three professional groups owing to data not being reported separately for ‘other’ types of health-care professionals and also to missing data on profession. The full questionnaire is provided in Appendix 7.

Demographic characteristics

Although 238 HCPs clicked into the survey via the invitation letter and consented to undertake the survey, only 229 respondents answered the first question. Respondents were asked their occupation (question 1, Q1) and their years of post-qualification experience (Q2). The response rate for Q1 was 96.22% (n = 229) and for Q2 was 95.38% (n = 227).

The respondents included 80 orthotists (34.93% of responders), 94 physiotherapists (41.05% of responders), 50 doctors in rehabilitation medicine (21.83% of responders) and five other types of HCP (one prosthetist/orthotist, two prothestists, one orthotic technician and one podiatrist). Responses for the last group are provided in the overall responses, but not as an individual group, in the tables below.

Most commonly respondents had ≥ 16 years of post-qualification experience (44.49%, n = 101). Similar proportions had up to 5 years’ (19.38%, n = 44), 6–10 years’ (19.38%, n = 44) and 11–15 years’ (16.74%, n = 38) experience. This trend of years of experience held for the physiotherapists and the doctors in rehabilitation medicine, a larger proportion (40%, n = 32) of orthotists who had 0–5 years’ of post-qualification experience, and a small proportion (30%, n = 24) had ≥ 16 years’ experience.

Respondents were asked where their clinical setting was located (Q3). The response rate was 92.44% (n = 220): 96.25% of orthotists, 100% of physiotherapists and 88% of rehabilitation medicine physicians. The vast majority (82.27%, n = 181) of respondents’ clinical setting was in England, 10.45% (n = 23) were based in Scotland, 3.18% (n = 7) in Wales and 3.64% (n = 8) in Northern Ireland.

When asked about the type of clinical setting(s) in which they work (Q4), the question response rate was 92.44% (n = 220); 96.25% of orthotists, 98.94% of physiotherapists and 88% of rehabilitation medicine physicians. The majority of respondents (65.91%, n = 145) were from a NHS setting, 9.09% (n = 20) a private company setting, and both NHS and private settings (18.18%, n = 40). Fifteen respondents (6.82%) chose ‘other’ settings, 11 of whom described their clinical setting, which included private domiciliary (n = 1); a subcontracted private company within the NHS (n = 1); a university setting (n = 3); private community (n = 1); Ministry of Defence (n = 1); self-employed (n = 1) and retired (n = 1).

Respondents were asked how orthotic services in their clinical setting are provided (Q5). No single model predominated: 38.89% (n = 84) reported that orthotic services are provided as an integrated part of a MDT service and 46.76% (n = 101) within a stand-alone prescribing/fitting orthotic service. Thirty-one respondents (14.35%) chose the ‘other’ option (Table 14).

Thirteen orthotists chose the ‘other’ option and their responses indicated that the orthotic services in their setting are a combination of both MDTs and stand-alone services. This was also the case for both doctors in rehabilitation medicine who chose ‘other’. There was a variety of responses from the 15 physiotherapists who chose the ‘other’ option: one physiotherapist worked with a podiatrist to access FOs but other orthotic devices prescribed are provided through a stand-alone orthotic service. Five physiotherapists stated that they source orthoses themselves directly from orthotics companies. One physiotherapist stated that their orthotic service was provided as part of a therapy team, which was not a wider MDT. One physiotherapist is part of a privately run rehabilitation service, and patients are referred to the NHS for orthotic devices. Two respondents stated a mix of both stand-alone and MDTs; one respondent stated provision varies depending on whether it is available through the NHS or privately.

The respondents who stated that the orthotic services in their clinical setting are provided by a MDT were asked what HCPs make up their MDT (Q6).

The majority of respondents’ MDTs include a physiotherapist (96.43%), an orthotist (79.76%), occupational therapists (69.05%) and doctors in rehabilitation medicine (60.71%) (Table 15). A smaller proportion reported a gait scientist as part of the MDT (10.71%). Nineteen (22.62%) respondents’ MDTs included HCPs other than those listed.

Six orthotists chose ‘other’ HCPs. Five orthotists stated that their MDTs also included a podiatrist, and one stated they also include community therapists. Eight physiotherapists chose ‘other’ HCPs. Their responses included podiatrists, speech and language therapists, psychologists/neuropsychologists, rehabilitation assistants, inpatient nursing team, geriatricians, social workers, dietitians and one respondent stated ‘patient and family’. Four doctors in rehabilitation medicine chose ‘other’ HCPs. Among the HCPs stated were speech and language therapists, clinical psychologists, dietitians, plastic surgeons, psychologist/neuropsychologist and prothestists.

Patient demographics

A series of questions was asked to ensure that the respondents for the survey are currently treating, or have recently treated, adult patients with NMD and/or CNS with knee instability (Q7–10).

In relation to adult patients with NMD with knee instability, 66.34% (n = 136) of respondents reported that they treat, or have recently treated, this population: 33.66% (n = 69) had not and 33 respondents did not answer this question (response rate to question 86.13%, n = 205).

In relation to adult patients with CNS disorders with knee instability, 83.82% (n = 171) of respondents reported that they treat, or have recently treated, this population, 16.18% (n = 33) had not and 34 respondents did not answer this question (response rate to question 85.71%, n = 204).

The respondents who stated that they currently treat, or have recently treated, these patients were then asked about the types of CNS conditions and/or NMD that they see most frequently. Responses are presented in Table 16.

The most common type of NMD disorder being treated was post-polio syndrome (76.92%), followed by poliomyelitis (70.19%), motor neurone disease (68.27%), CMT disease (68.27%), Guillain–Barré Syndrome (65.38%), muscular dystrophy (58.65%), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP; 46.15%) and inclusion body myositis (22.12%).

The most common type of CNS condition being treated was stroke (100%), followed by multiple sclerosis (82.80%), traumatic brain injury (70.06%), acquired brain injury (64.97%), spinal cord disorders (62.42%) and adult cerebral palsy (50.32%).

The respondents who stated that they do not currently treat, and have not recently treated, patients with a NMD or a CNS condition with knee instability n = 23 (9.66%, n = 238 total) were directed to the end of the survey.

From this section onwards, some questions were asked specifically about NMD/CNS patients with knee instability. Therefore, only the questions relevant to the respondents, based on Q7 and Q9 were displayed to the respondents.

Patient referrals

Those respondents who stated that they treat, or have recently treated, patients with NMD were asked how these patients would routinely be referred to them (Q11). Referrals were from a wide range of sources (Table 17).

A substantial proportion of referrals are from GPs (59.85%), physiotherapists (62.77%) and neurologists (63.50%), with orthopaedic surgeons (37.96%) and doctors in rehabilitation medicine (40.88%) also being significant sources of referrals. A total of 23 respondents chose ‘other’ as the HCPs that refers patients with NMD to them; this included 14 (30.43%) of the physiotherapists. The responses provided by these respondents indicated that there can be self-referrals and referrals through inpatient systems. Orthotists can receive referrals from podiatrists, community physiotherapists, the MDT team and self-referrals from patients. Physiotherapists also receive referrals from the inpatient ward, self-referrals from patients, and referrals from oncologists, stroke doctors and case managers. Rehabilitation medicine physicians can receive referrals from community stroke rehabilitation teams.

Those respondents who stated that they treat, or have recently treated, patients with CNS conditions were asked how these patients would routinely be referred to them (Q12).

As for patients with NMD, a substantial proportion of referrals are from GPs (59.64%), physiotherapists (65.66%) and neurologists (55.42%), with doctors in rehabilitation medicine (43.98%) also a significant source of referral (Table 18). A total of 37 respondents chose ‘other’ as the HCPs that refer patients with CNS conditions to them; this included 31 (44.29%) of the physiotherapists. The responses provided by these respondents indicated that referrals can also be self-referrals (by the patients themselves) and referrals through inpatient systems (particularly stroke patients).

Orthotists can also receive referrals from medicolegal sources, community physiotherapists and self-referral from patients. Physiotherapists can also receive referrals from the inpatient ward, stroke units, a MDT member, oncologists, case managers, nursing homes, stroke doctors and self-referral from patients. Doctors in rehabilitation medicine can also receive referrals from the inpatient ward, spinal surgeons and neurologists. One rehabilitation medicine physician stated that he/she would never receive a direct referral for these conditions.

Respondents were asked what information is usually provided on referral of patients with NMD and/or CNS conditions (Q13).

Almost all respondents stated that they are provided with the patient diagnosis (94.64%) and two-thirds are provided with the patient’s medical details (Table 19). Smaller proportions reported being provided with physical assessment details (33.93%), with the aims and goals of the orthotic intervention (32.14%), with the type of orthoses provided (20.24%) and with a gait analysis report (1.79%). Twenty-two respondents chose ‘other’ and some provided further details. The orthotists are also sometimes provided with a suggestion of the orthoses required, what is required from them and medical details from medicolegal reports. Five orthotists also essentially stated that the aims/goals of the intervention would be provided. Physiotherapists are also provided with the reason for referral and care needs reports.

Respondents were asked what symptoms in patients with NMD and/or CNS conditions would trigger a referral to them for assessment (Q14).

The three options available appear to all trigger a substantial number of referrals and this was the case across the types of HCPs (Table 20). A number of respondents (20.12%) chose the ‘other’ option. Symptoms that would trigger a referral to an orthotist also include the patient having gait problems, the patient having poor function, and normal service provision not having worked for the patient. Symptoms that would trigger a referral to a physiotherapist also include the patient having gait problems, the patient having poor balance and a recent change in the patient’s comorbidities. Five physiotherapists stated that they see all patients. A doctor in rehabilitation medicine could also be referred a patient having gait problems.

The respondents were asked what other HCPs would assess the patients that are referred to them (Q17). Table 21 shows that physiotherapists would most commonly assess these patients (75.63%), followed by GPs (55%), neurologists (55%), doctors in rehabilitation medicine (50.63%), orthopaedic surgeons (43.75%), orthotists (41.25%), occupational therapists (37.50%), clinical nurse specialists (21.88%) and gait scientists (12.50%).

Fifteen respondents (9.38%) chose the ‘other’ option. One orthotist stated that any of the HCPs listed and any MDT member could potentially also assess these patients. Another orthotist stated that this information would not be available to them on referral. The physiotherapists stated that a consultant, a neurosurgeon and a podiatrist could also assess these patients. Two physiotherapists stated that any of the HCPs listed and any MDT member could potentially also assess these patients, and one physiotherapist stated that his/her patients would not be seen by any other HCP.

Respondents were asked if they thought that there were any barriers to patients being referred to them (Q15). Results are presented in Table 22. The most commonly reported response was that there were ‘sometimes’ barriers to patients being referred (47.85%), followed by ‘rarely’ (30.67%). Although the trend was similar for orthotists and rehabilitation medicine doctors, a higher proportion of physiotherapists felt that there were ‘rarely’ or ‘never’ barriers. This may be explained by the fact that physiotherapist respondents received more referrals from inpatient wards than the other groups; however, the difference is small.

When asked to briefly explain their answers, respondents described both the lack and the presence of barriers to patients being referred to them. Thirty-six of the comments indicated that there were no barriers. It appears that those HCPs with blanket referrals or working in an inpatient setting do not feel that there are barriers to patients being referred to them. However, there were a number of responses for which potential barriers to patient referrals were highlighted.

Lack of awareness and knowledge appear to be the main issues affecting referral of patients to orthotic services. Forty-one comments indicated that a lack of awareness by potential referrers of orthotists’ professional expertise was causing barriers to referrals. Two additional comments noted the lack of knowledge of GPs about patient conditions and four additional comments noted the lack of knowledge of the potential of orthotic devices for this patient population as barriers.

The ability to refer also appears to be affecting referrals for this patient population. Six comments referred to the inability of some HCPs to refer directly to orthotic services. For example, one respondent stated that they could only accept internal referrals; another stated that some areas only allow referrals from consultants and another noted the inability of GPs to provide direct referrals. Five comments indicated that there can be a lack of knowledge by potential referrers in the potential pathway for this patient population. Nine comments indicated that in some cases there are difficulties with the referral pathway, such as criteria required for referrals, making the process less than straightforward.

Seven comments detailed the poor access to service in some areas of the country. One respondent noted a ‘postcode lottery’ and another comment noted the ‘non-existent outpatient facility’ in their setting. Nineteen comments indicated that the cost was a barrier. Cost appears to be a factor both in terms of providing an orthotic service and the cost of referral for GPs. The financial status of the patient themselves was also highlighted, presumably if the cost needs to be borne by the patient. Eighteen comments indicated that long waiting times were causing barriers to referral. Ten comments noted late referrals, from both lack of awareness and long waiting times, as a barrier to treatment. It seems that patients are presenting at orthotic services when their condition has deteriorated to the point at which orthotic provision may no longer be beneficial.

Two comments noted that some settings accept referrals from large geographical areas (one respondent stated that referrals were accepted from all over the country), which provides a barrier as a result of patients having difficulty attending appointments. One comment noted the lack of hospital transport. Two comments also noted that sometimes patients do no seek help, which creates a barrier to referral.

Initial assessment

Respondents were asked the average waiting time for adult patients with NMD-related knee instability between referral of the patient to them and their initial assessment (Q19).

The majority of respondents reported that, on average, patients were seen within 12 weeks of referral (Table 23). Physiotherapists reported the shortest waiting times for referral (86.48% of physiotherapists said that referral occurred within 8 weeks).

Respondents were asked about the average waiting time for adult patients with CNS conditions with knee instability between referral of the patient to them and their initial assessment (Q20).

As for patients with NMD, the majority of respondents reported an average time from referral to initial assessment of up to 12 weeks (Table 24). A higher proportion of physiotherapists reported an average waiting time of up to 4 weeks than the other two groups.

Respondents were asked what assessments they would routinely undertake as part of their initial assessment of patients with NMD and/or CNS with knee instability (Q18). Results are presented in Table 25.

Respondents reported using a variety of combinations of initial assessments in their clinical practice. The majority of respondents routinely assess a patient’s muscle strength (95.42%), joint range of movement (ROM) and the quality of that movement (95.42%), the presence of spasticity (92.81%), patient expectations (89.54%); observe gait (88.89%); take history of pain/falls/walking ability (87.58%); and assess previous treatments (83.66%), sensation (83.01%), activity limitations (79.74%), ligament laxity (69.82%), proprioception (66.01%), aggravating factors (64.05%) and balance tests (57.52%). Smaller proportions reported using timed walking tests (33.33%) and imaging (18.95%).

It appears that formal gait analysis is rarely used as part of the initial assessment of patients with NMD and/or CNS conditions. Nine respondents chose the ‘other’ option. These respondents stated that they also routinely undertake the following assessments: functional movement tests, such as sit-to-stand or stairs; assessment of psychological limitations and social inclusion; ability/inability to stand; and lifestyle assessments. Respondents stated that they would also undertake the following: review of any imaging or related reports as part of assessment; assessment of pain, balance and confidence in walking with numeric rating scales; assessment of current orthosis; and assessment of patient’s expectations and understanding of the limitations of treatment.

Prescription and fitting of orthotic devices

This section of the survey began by asking our respondents if, in their routine work, they prescribe or fit orthotic devices for adult patients with NMD and/or CNS conditions, with knee instability (Q24).

The majority of respondents (70.21%) prescribe or fit orthotic devices for patients with NMD/CNS conditions, with knee instability (Table 26). All but two orthotists prescribe/fit orthotic devices for this patient group (96.72%). Slightly more of our respondents who were physiotherapists and doctors in rehabilitation medicine do not prescribe/fit orthotic devices for this patient group (50% and 52%, respectively).

In order to reduce the burden on respondents, those who answered no to this question subsequently skipped all of the questions that assumed that the respondent prescribed or fitted orthotic devices. Those respondents who stated that they did not prescribe or fit devices to this patient group were asked to which HCP they would refer patients requiring prescription and fitting of orthotic devices (Q25). The results of this question are presented in Tables 27 and 28, and indicated that the most common referrals for prescribing or fitting an orthosis was to an orthotist.

Types of devices

The respondents were asked about what types of orthotic devices they prescribe for patients with NMD and/or CNS conditions with knee instability (Q26). The results for this question are presented in Table 29.

Ankle–foot orthoses appear to be the device prescribed by most respondents (93.94%), followed closely by knee braces (88.89%) and KAFOs (74.75%). Eighteen respondents (18.18%) chose ‘other’ for the type of orthotic device prescribed. Patients with NMD and CNS conditions with knee instability are also prescribed ‘FOOT-UP’^® Orthoses (Össur, Reykjavik, Iceland), Lycra, ‘heel raises’, ankle supports, GRAFOs, taping and anti-hyperextension cages.

Respondents were also asked about what types of orthotic devices they fit for patients with CNS conditions and/or NMD with knee instability (Q27). Only 14 respondents (8.24%) stated that they do not fit any devices, indicating that the majority of respondents both prescribe and fit orthotic devices for patients with CNS conditions and/or NMD with knee instability (Table 30). The responses to this question were very similar to the responses to the previous question on prescribing. The most commonly fitted devices overall were AFOs (89.90%), knee braces (87.88%) and KAFOs (65.66%). Fourteen respondents (14.14%) chose ‘other’ for the type of orthotic device prescribed. Seven orthotists chose ‘other’ and stated that spinal supports, heel raises and Lycra supports could also be fitted. Four physiotherapists chose ‘other’ and stated that FOOT-UPS, taping, GRAFOs and sensory dynamic orthoses could also be fitted. Four doctors in rehabilitation chose ‘other’; responses stated that the orthoses that they prescribe would be fitted by an orthotist.

Respondents were asked what proportion (approximately) of the devices that they prescribe/fit for patients with CNS conditions and/or NMD is custom-made (Q28).

The results indicated that approximately half of all devices prescribed/fitted by our respondents were reported to be custom-made devices (Table 31). This is the case for both orthotists and doctors in rehabilitation medicine; however, physiotherapists indicated that approximately one-third of the devices that they prescribe are custom-made devices. Respondents were then asked what influences their decision to prescribe a custom-made or an off-the-shelf device (Q29). The question response rate was 55.03% (n = 93). The comments indicate that there are patient and device factors that influence the HCPs’ decision.

Provision of orthoses

In order to get an indication of how many visits were required to provide orthotic devices, respondents were asked how many visits would be needed depending on whether it was a patient with NMD or CNS condition, and what device they were prescribing (Q34, Q36). Respondents were asked how many visits are normally required to provide orthotic devices for patients with NMD. The results of this question and response rates are presented in Table 33. These underestimate the question response rate, as this is the number of respondents who responded to each element of the answer rather than those who supplied an answer for Q34 and Q36.

Respondents were also asked how many visits are normally required to provide orthotic devices for patients with CNS conditions. The results of this question are presented in Table 34 (Q35, Q37). As with the previous table, the response rates are an underestimate, as this is the number of respondents who responded to each element of the answer rather than those who supplied an answer for Q35 and Q37.

For all devices and for both patients with NMD and CNS conditions, custom-made devices were found to require additional visits to HCPs compared with off-the-shelf devices in order for the patients to be provided with orthotic devices.

For patients with both NMD and CNS conditions, the custom-made KAFO required the most visits, with an average of three visits to HCPs in order to be fitted with a KAFO; off-the-shelf insoles required the least number of visits (average of 1.62 visits for patient with NMDs and 1.54 for those with CNS conditions).

Typical length of appointments

Respondents who stated that they prescribe or fit orthotic devices for patients with NMD and/or CNS conditions were also asked a series of questions regarding the typical duration of particular appointments discussed. Respondents moved a slider within the range of 0–60 minutes.

The length of appointment required for an initial assessment (Q21) is presented in Table 38.

The responses indicate that it takes on average 38 minutes for an initial assessment appointment, with orthotists taking slightly less time than the other HCPs at 28 minutes. These appointments can vary in length, from 0 minutes to 60 minutes.

The length of appointment required for the casting and measuring of orthotic devices (Q32) is presented in Table 39. The response rate was 50.29% (n = 86): 76.39% of the orthotists, 36.54% of the physiotherapists and 28.13% of the doctors in rehabilitation medicine responded to the question.

The respondents required slightly more time to cast and measure custom-made devices than for an off-the-shelf device. On average, for custom-made devices the appointment length was 38.31 minutes compared with 25.57 minutes for off-the-shelf devices. The mean duration for physiotherapists was slightly longer for both custom-made and off-the-shelf devices.

The respondents who stated that they do provide a review appointment were asked how long a review visit lasts, on average (Q23). The mean duration of review appointments was 27 minutes. This ranged from 1 minute to 45 minutes (Table 40). Physiotherapists’ review visits lasted slightly longer on average than those of the other HCPs.

Patient information at fitting appointments

Respondents were asked what information they provided to patients at fitting appointments (Q38). The majority of the respondents indicated that they relay all of the information in the options provided (Table 41).

Almost all respondents reported providing instructions on taking the device on and off (95.29%); instructions on use of the orthosis (94.12%); when to wear the orthosis (92.94%); when to seek a review appointment (89.41%); and how to monitor the fit of the orthosis (88.24%). Fifteen respondents choose the ‘other’ option.

The response from the orthotists stated that information on the following would also be provided to patients: safety checks, instructions on lifespan and replacement of the orthosis, instructions on adjustment of the orthosis, a review of the goal of the orthosis, instructions on weaning procedure, skin care, and instructions on suitable footwear if an AFO or KAFO is being provided. One doctor in rehabilitation medicine stated that their patient would be provided with the phone number of the rehabilitation consultant’s secretary.

Respondents were asked in what form they provide information to patient at fitting appointments (Q39).

The majority of respondents reported providing information to patients verbally (91.95%), through short leaflets (70.11%) and, to a lesser extent, instruction booklets (44.83%) (Table 42). A small number of respondents (four orthotists and three physiotherapists) direct patients to a website; none provided information on CDs.

Six respondents chose the ‘other’ option. The orthotists stated a safety agreement is signed and returned from the patient and retained in the patient’s notes. The physiotherapists stated they used written notes and within discharge reports, and one physiotherapist stated that this would not be their role.

Long-term review appointments

Respondents were asked whether or not they routinely offer long-term review appointments (Q40).

A slightly higher proportion of respondents (54.12%) do not routinely provide long-term review appointments than those who do (45.88%), and this is particularly noticeable in the physiotherapist group (Table 43). Slightly more doctors in rehabilitation medicine do provide long-term review appointments than those who do not.

In a separate question, respondents were asked if their practice has a ‘review on request’ option for patients (Q46).

The results show that a substantial majority of respondents operate ‘review on request’ appointments within their clinical setting (88.24%) compared with those who do not (11.76%) (Table 44). The results from both questions on long-term review appointments indicate that instead of prespecified review appointments, review appointments can be instigated by patients.

Quantifying the success of an orthotic device

Following on from the questions on fitting and reviewing the orthotic devices, respondents were asked how they would normally quantify the success of an orthosis when fitting/reviewing the device (Q42).

Respondents rely on patient feedback (94.87%), family/carer feedback (84.62%), and observational gait analysis (87.18%) a significant proportion of the time to quantify the success of the device (Table 45). Formal gait analysis via video gait analysis or video vector gait analysis appears to be used to a lesser extent (17.95% and 2.56%, respectively). One respondent stated that they used none of the above measures to quantify the success of the device. Two respondents chose the ‘other’ option. Only one respondent provided a text response and stated they were unable to comment as the ‘orthotist would provide this response’.

Device breakages

The respondents were asked several questions about what happens when orthotic devices break. Respondents were asked separately what procedures are in place in their setting if custom-made or off-the-shelf devices break or are damaged (Q43, Q44).

The most commonly used options in the event of breakage of a custom-made device were provision of a spare orthosis to the patients at the same time as they receive the original device (36.47%); provision of an off-the-shelf device until the prescribed device is repaired (32.94%); and use of on-the-spot repair at an on-site workshop (37.65%) (Table 46). Provision of a wheelchair until the device is repaired was reported by 7.06% of respondents. Twenty-two respondents chose the ‘other’ option (13 orthotists, 8 physiotherapists and 1 doctor in rehabilitation medicine). In the responses provided, the orthotists stated the following: a spare device is provided after first satisfactory review (n = 3); this would depend on the device (n = 3); the patient would have to wait (n = 1); no procedures are in place (n = 1); this is dependent on patient funding (n = 1) or dependent on NHS trust protocol (n = 1); and this is also dependent on whether or not the patient can travel to an off-site workshop (n = 1). The physiotherapists stated that patients are referred to the orthotist for review and/or replacement (n = 6); the patient has to wait (n = 1); and no procedures are in place (n = 1). One doctor in rehabilitation medicine stated that he or she would call the company.

The most commonly used options in the event of breakage of an off-the-shelf device were use of on-the-spot repair at an on-site workshop (37.65%) and provision of a spare orthosis to the patient at the same time as they receive the original device (30.59%) (Table 47). Provision of a wheelchair until the device is repaired was reported by 3.53% of respondents. Forty respondents chose the ‘other’ option (22 orthotists, 16 physiotherapists and 2 doctors in rehabilitation medicine). Several respondents (four orthotists, four physiotherapists and one doctor in rehabilitation medicine) stated that a replacement is provided on the day if stock is available or soon as possible otherwise. A further six orthotists and two physiotherapists stated that a replacement device is ordered. One orthotist can provide emergency appointments to fit a new device. Four orthotists provide a spare device after the first satisfactory review.

Similar to the procedure for custom-made devices, patients sometimes have to wait (two orthotists) and no procedures are currently in place in some settings (two orthotists and one physiotherapist). Four physiotherapists refer the patient to the orthotist for review and/or replacement. Once again, one doctor in rehabilitation medicine stated that he/she would call the company.

Respondents were also asked who repairs the device when it breaks (Q45). The results for this question indicated that off-site technicians most commonly repair broken devices (56.32%) (Table 48). However, given the high response rate of the orthotists in comparison with the other HCPs for this question, this may not be the case for all clinical settings and for all HCPs prescribing and fitting orthotic devices.

Fourteen respondents selected the ‘other’ option. This included two orthotists, 11 physiotherapists and one doctor in rehabilitation medicine. The orthotists responses stated that this depends on the site and the required repair. The physiotherapists stated the following: the device is replaced and not repaired (n = 3); the orthotist repairs the device (n = 2); this depends on the device (n = 1); and they do not know who repairs the device when it breaks (n = 4); one did not elaborate.

Treatment outcomes and acceptability factors

Respondents were asked a series of questions exploring treatment outcomes, acceptability factors and patient expectations.

Patient preferences

Respondents were asked about the extent to which they agreed that their patients are expressing a preference for particular devices (Q48).

Most commonly respondents stated that they neither agreed nor disagreed that their patients are expressing a preference for particular devices (46.40%) (Table 54). The respondents who chose ‘strongly agree’ or ‘agree’ were asked about what types of devices their patients were expressing a preference for. The responses to this question can be categorised into device factors and patient factors.

Effectiveness of device

Respondents were asked about the extent to which the following factors affect the effectiveness of the device (Q52). The question response rate (based on the number who completed all the questions) was 38.50% (n = 82) (67.57% of the orthotists, 28.05% of the physiotherapists and 20% of the doctors in rehabilitation medicine). The overall responses to this question are presented in Table 59. A total of 131 respondents did not answer this question (who included 24 orthotists, 59 physiotherapists and 36 doctors in rehabilitation medicine).

The majority of respondents chose ‘always’ for pain due to the device (70.73%), pressure areas due to the device (62.2%), acceptability of the device to patient (59.76%), patient adherence (59.76%) and for fit of the device (64.63%). The most popular response was ‘most of the time’ for therapy back-up (43.90%), for medical back-up (46.34%) and ‘rarely’ for surgical back-up (42.68%). Tables 60–62 present the results by profession; the results were broadly similar across professions.

Respondents were asked if they thought that there were other factors that affected the effectiveness of the device (Q53). The question response rate was 58.22% (n = 124): 70.27% of the orthotists, 60.98% of the physiotherapists and 48.89% of the doctors in rehabilitation medicine responded to the question. Eighty-six respondents (69.35%) stated that there were no other factors that they thought affected the effectiveness of the device, while 38 respondents (30.65%) stated that there were other factors. Eight-nine respondents did not answer this question. The 38 respondents who thought there were other factors were asked to specify these, and the responses to this question are presented below, categorised into patient factors, device factors and other factors.

Outcome measures

Respondents were asked what, if any, formal outcome measures they use to assess the effectiveness of orthotic devices (Q55).

There was no single outcome measure that was commonly in use across the sample (Table 63). Thirty-six respondents (29.03%) stated that they do not use a formal outcome measure. The most commonly used measures were a visual analogue scale (50.81%), the 10-m Walk Test (41.13%), the Timed Up and Go Test (35.48%), patient satisfaction questionnaire (33.87%) and the Goal Attainment Scale (27.42%). Twenty (16.13%) respondents stated that they use a formal outcome measure that was not listed in the response options.

Three orthotists chose ‘other’ and stated that patient feedback at review appointment and ’measures against named goals’ were also used. Fifteen physiotherapists chose ‘other’. They reported using the Berg balance scale (n = 5); the ‘timed and videoed functional movement test’ (n = 1); the ‘timed 360 degree test’ (n = 1); the ’Tinetti Test’ (n = 1); the ’Leeds Movement Performance Index’ (n = 1); the ‘Walk 12 Scale’ (n = 1); the ’6-Minute Walk Test’ (n = 1); the ‘Modified Rivermead Mobility Index’ (n = 1); ‘Functional SMART goals’ (n = 1); and ‘TUSS’ (presumably in reference to the Timed Unsupported Steady Stand) (n = 1). One physiotherapist also stated ‘usually being seen by other therapists if having treatment so I will goal set and they will use formal outcome measures’. Two doctors in rehabilitation medicine chose ‘other’. One stated that patient satisfaction measurement by the hospital can also be used.