An exploration of the experiences and utility of functional electrical stimulation for foot drop in people with multiple sclerosis.

Purpose: Functional electrical stimulation (FES) is effective in improving walking in people with multiple sclerosis (MS) with foot drop. There is limited research exploring people's experiences of using this device. This study aims to explore the utility, efficacy, acceptability, and impact on daily life of the device in people with MS.Methods: An interpretative phenomenological approach was employed. Ten participants who had used FES for 12 months were interviewed. Transcripts were analysed, and emergent themes identified.Results: Nine participants continued to use the device. Three relevant super-ordinate themes were identified; impact of functional electrical stimulation, sticking with functional electrical stimulation, and autonomy and control. Participants reported challenges using the device; however, all reported positive physical and psychological benefits. Intrinsic and external influences such as; access to professional help, the influence of others, an individual's ability to adapt, and experiences using the device, influenced their decisions to continue with the device. A thematic model of these factors was developed.Conclusions: This study has contributed to our understanding of people with MS experiences of using the device and will help inform prescribing decisions and support the continued, appropriate use of FES over the longer term.Implications for RehabilitationPeople with multiple sclerosis using functional electrical stimulation report benefits in many aspects of walking, improved psychological well-being and increased engagement in valued activities.A number of challenges impact on functional electrical stimulation use. Factors such as; a positive experience using the device, access to professional help, the influence of others, a strong sense of personal autonomy and an individual's ability to adapt, influence an individual's decision to continue using functional electrical stimulation.Clinicians prescribing functional electrical stimulation should be aware of these factors so that the right support and guidance can be provided to people with multiple sclerosis, thus improving outcomes and compliance over the long term.

Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: qualitative interview study of patient perspectives.

OBJECTIVES: Adults with knee instability related to neuromuscular disorders or central nervous conditions often experience mobility problems and rely on orthoses to improve function and mobility. Patient views of device effectiveness and acceptability are underexplored. Our study aimed to elicit device users' perspectives regarding fitting, acceptability, effectiveness and use of orthoses, and identify important treatment outcomes. DESIGN: Qualitative descriptive study using in-depth semistructured interviews. Interview transcriptions were coded and thematically analysed, using 'Framework'. SETTING AND PARTICIPANTS: A purposive sample of 24 adult users of orthotic devices. Nineteen patients were recruited across three National Health Service sites, and five people through charities/patient support groups in England. Half of the participants had been diagnosed with poliomyelitis, and the remainder with multiple sclerosis, Charcot-Marie-Tooth disease, spinal injury or spina bifida, and stroke. The median age of participants was 64.5 years (range 36-80 years). RESULTS: Patients' medical condition impacted significantly on daily life. Participants relied on orthotic devices to enable engagement in daily activities. Patient goals for mobility were linked to individual circumstances. Desired treatment outcomes included reduction in pain, trips and falls, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses and associated with reported use. Obtaining suitable footwear alongside orthotic devices was a significant concern. Time pressures during device fitting were viewed negatively. CONCLUSIONS: Orthotic devices for knee instability play a crucial role in promoting, maintaining and enhancing physical and psychological health and well-being, enabling patients to work, engage in family life and enjoy social activities. Future research should consider how best to measure the impact of orthotic devices on patient quality of life and daily functioning outside the clinic setting, as well as device use and any adverse effects. TRIAL REGISTRATION NUMBER: This qualitative study was retrospectively registered as Current Controlled Trials ISRCTN65240228.

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES device (n = 42). OUTCOME MEASURES: Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions. RESULTS: Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, n = 21; FES, n = 11). Both groups walked faster at 12 months with device (P < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence (P = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (P = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem (P = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

Post-stroke ankle-foot orthoses: Examining referral trends in the Scottish multi-disciplinary team.

PURPOSE: As per the Best Practice Statement: Use of Ankle-Foot Orthoses Following Stroke (BPS), members of the stroke multidisciplinary team should refer stroke patients with mobility problems to orthotics. Therefore, the objectives of this study were to (1) assess awareness of the BPS; (2) assess referral patterns and trends; and (3) identify barriers to referral to the Orthotic Service in Scotland. METHODS: An online survey of the stroke MDT, working in Scotland, whose current role involves work with stroke patients. A survey was distributed via the Scottish Stroke Allied Health Professionals Forum, Scottish Stroke Nurses Forum, British Association of Stroke Physicians, and Scottish Stroke Managed Clinical Networks. RESULTS: Statistically significant association was found between: Awareness of BPS and NHS Board Area; Profession and whether clinicians have referred to orthotics; Confidence in assessment criteria and profession; Referral to departments other than Orthotics and profession. CONCLUSION: Physiotherapists are relied upon by members of the Stroke MDT to identify mobility problems and refer to Orthotics. The BPS should be re-disseminated, particularly to the East of Scotland and GPs, to improve awareness of referral criteria. Reduced waiting list times and joint physiotherapist-orthotist clinics may reduce referral barriers to the Orthotic Service.

A comparison of the initial orthotic effects of functional electrical stimulation and ankle-foot orthoses on the speed and oxygen cost of gait in multiple sclerosis.

BACKGROUND: Foot drop affects walking in people with multiple sclerosis (pwMS). This study compares the initial orthotic effects of two treatments for foot drop: ankle-foot orthoses (AFO) and functional electrical stimulation (FES), on the speed and oxygen cost of walking in MS. METHOD AND MATERIALS: Seventy-eight pwMS were randomised to receive AFO or FES (ODFS PACE (OML, Salisbury, UK)). Participants completed the 25-ft walk test (25ftWT) and 5-min self-selected walk test (5minSSWT), from which oxygen cost was determined, with and without their device. Between-, within- and sub-group analyses (based on baseline walking speed of <0.8 m/s (slow) or ≥0.8 m/s (fast)) were undertaken. RESULTS: No significant differences between baseline measures were observed. The AFO group walked significantly slower than the FES group (5minSSWT, p = 0.037, 0.11 m/s). The AFO group walked significantly slower with than without AFO (25ftWT, p = 0.037), particularly in the fast-walking group ( p = 0.011). The slow-walking FES group walked significantly faster with FES than without (25ftWT; p = 0.029, 5minSSWT; p = 0.037). There were no differences in the fast-walking FES group or in the oxygen cost for either device. CONCLUSION: AFO reduced walking speed, particularly in fast walkers. FES increased walking speed in slow, but not fast walkers.

Systematic review of the evidence on orthotic devices for the management of knee instability related to neuromuscular and central nervous system disorders.

OBJECTIVES: To assess the effectiveness of orthotic devices for the management of instability of the knee in adults with a neuromuscular disorder or central nervous system disorder. DESIGN: A systematic review of primary studies. SETTING: Community. PARTICIPANTS: Adults with a neuromuscular disorder or central nervous system disorder and impaired walking ability due to instability of the knee. INTERVENTIONS: Orthoses with the clinical aim of controlling knee instability, for example, knee-ankle-foot orthoses, ankle-foot orthoses and knee orthoses or mixed design with no restrictions in design or material. PRIMARY AND SECONDARY OUTCOME MEASURES: Condition-specific or generic patient-reported outcome measures assessing function, disability, independence, activities of daily living, quality of life or psychosocial outcomes; pain; walking ability; functional assessments; biomechanical analysis; adverse effects; usage; patient satisfaction and the acceptability of a device; and resource utilisation data. RESULTS: Twenty-one studies including 478 patients were included. Orthotic devices were evaluated in patients with postpolio syndrome, poststroke syndrome, inclusion body myositis and spinal cord injury. The review included 2 randomised controlled trials (RCTs), 3 non-randomised controlled studies and 16 case series. Most were small, single-centre studies with only 6 of 21 following patients for 1 year or longer. They met between one and five of nine quality criteria and reported methods and results poorly. They mainly assessed outcomes related to gait analysis and energy consumption with limited use of standardised, validated, patient-reported outcome measures. There was an absence of evidence on outcomes of direct importance to patients such as reduction in pain and falls. CONCLUSIONS: There is a need for high-quality research, particularly RCTs, of orthotic devices for knee instability related to neuromuscular and central nervous system conditions. This research should address outcomes important to patients. There may also be value in developing a national registry. REGISTRATION NUMBER SYSTEMATIC REVIEW: PROSPERO (CRD42014010180).

Functional Electrical Stimulation for Foot Drop in Multiple Sclerosis: A Systematic Review and Meta-Analysis of the Effect on Gait Speed.

OBJECTIVE: To review the efficacy of functional electrical stimulation (FES) used for foot drop in people with multiple sclerosis (pwMS) on gait speed in short and long walking performance tests. DATA SOURCES: Five databases (Cochrane Library, CINAHL, Embase, MEDLINE, and PubMed) and reference lists were searched. STUDY SELECTION: Studies of both observational and experimental design where gait speed data in pwMS could be extracted were included. DATA EXTRACTION: Data were independently extracted and recorded. Methodologic quality was assessed using the Effective Public Health Practice Project tool. DATA SYNTHESIS: Nineteen studies (described in 20 articles) recruiting 490 pwMS were identified and rated as moderate or weak, with none gaining a strong rating. All studies rated weak for blinding. Initial and ongoing orthotic and therapeutic effects were assessed regarding the effect of FES on gait speed in short and long walking tests. Meta-analyses of the short walk tests revealed a significant initial orthotic effect (t=2.14, P=.016), with a mean increase in gait speed of .05m/s, and ongoing orthotic effect (t=2.81, P=.003), with a mean increase of .08m/s. There were no initial or ongoing effects on gait speed in long walk tests and no therapeutic effect on gait speed in either short or long walk tests. CONCLUSIONS: FES used for foot drop has a positive initial and ongoing effect on gait speed in short walking tests. Further fully powered randomized controlled trials comparing FES with alternative treatments are required.

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

BACKGROUND: Patients who have knee instability that is associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee-ankle-foot orthoses (KAFOs). OBJECTIVES: To assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devices prescribed in the UK NHS; and associated costs. METHODS: Qualitative study of views of orthoses users - a qualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed and an inductive approach was used to identify themes. Systematic review - 18 databases were searched up to November 2014: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, Recal Legacy, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and National Technical Information Service. Studies of adults using an orthosis for instability of the knee related to NMD or a CNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis - a web survey of orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed a costing analysis. RESULTS: Qualitative study - a total of 24 people participated. Potential for engagement in daily activities was of vital importance to patients; the extent to which their device enabled this was the yardstick by which it was measured. Patients' prime desired outcome was a reduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems and referral pathways. Systematic review - a total of 21 studies (478 participants) were included of people who had post-polio syndrome, inclusion body myositis, were post stroke or had spinal cord injury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hip KAFOs. All of the studies were at risk of bias and, in general, were poorly reported. Survey and costing analysis - in total, 238 health-care professionals responded. A range of orthoses is prescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence in mobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553. CONCLUSIONS: Various types of orthoses are used in the NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence on the effectiveness of the orthoses is limited, especially in relation to the outcomes that are important to orthoses users. LIMITATIONS: The population included was broad, limiting any in-depth consideration of specific conditions. The response rate to the survey was low, and the costing analysis was based on some assumptions that may not reflect the true costs of providing KAFOs. FUTURE WORK: Future work should include high-quality research on the effectiveness and cost-effectiveness of orthoses; development of a core set of outcome measures; further exploration of the views and experiences of patients; and the best models of service delivery. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Determination of loads carried by polypropylene ankle-foot orthoses: a preliminary study.

Ankle-foot orthoses (AFOs) are prescribed for the management of gait-related problems. Prescription of AFOs is based on empirical techniques due to the low level of evidence-based research on their efficacy, but primarily poor understanding of their mechanical characteristics. This study aimed to establish a method that would allow the quantification of the contribution of AFOs in the control of the ankle joint during gait. A possible way of achieving this aim would be to measure strain on the AFO during walking by the use of strain gauges. Following successful experimentation with the application of strain gauges to polypropylene tensile specimens, an AFO was instrumented by attaching strain gauges to it so as to allow the moment generated on the AFO in the sagittal plane about the ankle to be measured. Walking trials using this AFO on an able-bodied subject indicated good step-to-step repeatability. The use of an instrumented AFO in conjunction with kinematic and kinetic data acquisition would allow the contribution of the AFO and the residual anatomical loads to be determined. The advantage of such procedure over previously reported ones resides on the use of the actual orthosis being worn by patients thereby conducting tests under real-life situations. It is believed that such analysis of the load actions of an orthosis, which may in future be carried out in three dimensions, would allow a better understanding of the interaction between the leg and the orthosis. This should ultimately enhance AFO prescription criteria and help in optimising patient/device matching.

The immediate effects of fitting and tuning solid ankle-foot orthoses in early stroke rehabilitation.

BACKGROUND: Ankle-foot orthoses are known to have a generally positive effect on gait in stroke, however the specifc type of AFO and the time point at which it is provided are highly variable in the currently available literature. OBJECTIVE: The objective was to determine the immediate spatiotemporal and kinematic effect of custom-made solid ankle-foot orthoses in early stroke rehabilitation, compared to shod walking. METHODS: Five male and three female participants were recruited to the study (n = 8), with a mean age of 57 (16) years who were 3.5 (3) weeks post-stroke. Each received a custom-made solid ankle-foot orthosis to a predefined set of design criteria and tuned using heel wedges to control the shank inclination angle during shod walking. Repeated spatiotemporal and three-dimensional gait measures were taken pre- and immediately post-intervention. STUDY DESIGN: A pre-post-test experimental study. RESULTS: With the solid ankle-foot orthosis, walking velocity increased from 0.22 (0.2) to 0.36 (0.3) m/s (p < 0.05), overall average step length increased from 0.28 (0.1) to 0.37 (0.1) m (p < 0.05), cadence increased from 45 (19) to 56 (19) steps/min (p < 0.05) and step length symmetry ratio increased from 0.65 (0.2) to 0.74 (0.2) (not significant). No clear changes were observed in the joint kinematics of the hip and knee. CONCLUSION: In our small group of early stroke patients who were fitted with a solid ankle-foot orthosis, immediate significant improvements occurred in walking speed, step length and cadence, when compared to walking with shoes only. CLINICAL RELEVANCE: This study provides evidence about the immediate effects of custom solid ankle-foot orthoses on gait of early stroke survivors. Ankle-foot orthosis design specifications are fully described for replication. This study suggests that observing global segment orientation may be more useful than joint angles when fitting and tuning ankle-foot orthoses for optimal ankle-foot orthosis/footwear alignment.

Affordable clinical gait analysis: an assessment of the marker tracking accuracy of a new low-cost optical 3D motion analysis system.

BACKGROUND: 3D motion analysis represents a method of collecting objective, accurate and repeatable gait data, however the high cost of equipment inhibits its widespread use in routine clinical practice. OBJECTIVE: To determine the marker tracking accuracy of a new low-cost optical 3D motion analysis system. DESIGN: Comparative between-system study. SETTING: Clinical motion analysis laboratories. METHODS: A rigid cluster of four reflective markers was used to compare a low-cost Optitrack 3D motion analysis system against two more expensive systems (Vicon 612 and Vicon MX). Accuracy was measured by comparing the mean vector magnitudes (between each combination of markers) for each system, and reliability was measured through the coefficients of variation (CV). Gaps in the marker trajectories, which are considered undesirable, were also counted. RESULTS: In terms of accuracy, the largest disagreement between mean vector magnitudes for Optitrack and Vicon MX was 2.2%. The largest disagreement between Vicon 612 and Vicon MX was 2.1%. Regarding reliability, the mean CV was lowest in Vicon MX (0.3%) and similar in the Vicon 612 (2.5%) and Optitrack (2.3%) systems. The number of trajectory gaps for the Vicon MX, Vicon 612 and Optitrack systems were; zero, six and 11 respectively. CONCLUSIONS: The Optitrack system provides a low-cost 3D motion analysis system that can offer marker tracking accuracy and reliability which is comparable with an older and still widely used system (Vicon 612). Further development work is required before Optitrack can be used for full 3D gait analysis by physiotherapists and other health professionals.

Visualisation to enhance biomechanical tuning of ankle-foot orthoses (AFOs) in stroke: study protocol for a randomised controlled trial.

BACKGROUND: There are a number of gaps in the evidence base for the use of ankle-foot orthoses for stroke patients. Three dimensional motion analysis offers an ideal method for objectively obtaining biomechanical gait data from stroke patients, however there are a number of major barriers to its use in routine clinical practice. One significant problem is the way in which the biomechanical data generated by these systems is presented. Through the careful design of bespoke biomechanical visualisation software it may be possible to present such data in novel ways to improve clinical decision making, track progress and increase patient understanding in the context of ankle-foot orthosis tuning. METHODS: A single-blind randomised controlled trial will be used to compare the use of biomechanical visualisation software in ankle-foot orthosis tuning against standard care (tuning using observation alone). Participants (n = 70) will have experienced a recent hemiplegia (1-12 months) and will be identified by their care team as being suitable candidates for a rigid ankle-foot orthosis. The primary outcome measure will be walking velocity. Secondary outcome measures include; lower limb joint kinematics (thigh and shank global orientations) & kinetics (knee and hip flexion/extension moments, ground reaction force FZ2 peak magnitude), step length, symmetry ratio based on step length, Modified Ashworth Scale, Modified Rivermead Mobility Index and EuroQol (EQ-5D). Additional qualitative measures will also be taken from participants (patients and clinicians) at the beginning and end of their participation in the study. The main aim of the study is to determine whether or not the visualisation of biomechanical data can be used to improve the outcomes of tuning ankle-foot orthoses for stroke patients. DISCUSSION: In addition to answering the primary research question the broad range of measures that will be taken during this study are likely to contribute to a wider understanding of the impact of ankle-foot orthoses on the lives of stroke patients. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN52126764.

Orthotic management of cerebral palsy: recommendations from a consensus conference.

An international multidisciplinary group of healthcare professionals and researchers participated in a consensus conference on the management of cerebral palsy, convened by the International Society for Prosthetics and Orthotics. Participants reviewed the evidence and considered contemporary thinking on a range of treatment options including physical and occupational therapy, and medical, surgical and orthotic interventions. The quality of many of the reviewed papers was compromised by inadequate reporting and lack of transparency, in particular regarding the types of patients and the design of the interventions being evaluated. Substantial evidence suggests that ankle-foot orthoses (AFOs) that control the foot and ankle in stance and swing phases can improve gait efficiency in ambulant children (GMFCS levels I-III). By contrast, little high quality evidence exists to support the use of orthoses for the hip, spine or upper limb. Where the evidence for orthosis use was not compelling consensus was reached on recommendations for orthotic intervention. Subsequent group discussions identified recommendations for future research. The evidence to support using orthoses is generally limited by the brevity of follow-up periods in research studies; hence the extent to which orthoses may prevent deformities developing over time remains unclear. The full report of the conference can be accessed free of charge at www.ispoint.org.

Development of a best practice statement on the use of ankle-foot orthoses following stroke in Scotland.

A National Health Service Quality Improvement Scotland (NHS QIS) scoping exercise in 2007 identified the use of ankle-foot orthoses (AFOs) following stroke as a clinical improvement priority, leading to the development of a best practice statement (BPS) on AFO use after stroke. This paper outlines the development process of the BPS which is available from NHS QIS. The authors were involved as part of a working group that included practitioners from the fields of orthotics, physiotherapy, stroke nursing and bioengineering, staff of NHS QIS and a patient representative. In consultation with an NHS QIS health services researcher, the authors undertook a systematic literature review to evidence where possible the recommendations made in the BPS. Where evidence was unavailable, consensus was reached by the expert working group. As the BPS was designed for the non-specialist and non-orthotic practitioner the authors also developed educational resources which were included within the BPS to aid the understanding of the principles underpinning orthotic design and prescription. The BPS has been widely distributed throughout the health service in Scotland and is available electronically at no cost via the NHS QIS website. As part of an ongoing evaluation of the impact of the BPS on the quality of orthotic provision, NHS QIS has invited feedback regarding successes and challenges to implementation.