Delphi consensus study and clinical practice guideline development for functional electrical stimulation to support upright mobility in people with an upper motor neuron lesion.

PURPOSE: A Clinical Practice Guideline (CPG) is required to provide guidance on optimal service delivery for Functional Electrical Stimulation (FES) to support upright mobility in people living with mobility difficulties due to an upper motor neuron lesion, such as stroke or multiple sclerosis. A modified Delphi consensus study was used to provide expert consensus on best practice. METHODS: A Steering Group supported the recruitment of an Expert Panel, which included a range of stakeholders who participated in up to three survey rounds. In each round, panelists were asked to rate their agreement with draft statements about best practice using a 6-point Likert scale and add free text to explain their answer. Statements that achieved over 75% agree/strongly agree on the Likert scale were included in the CPG. Those that did not were revised based on free text comments and proposed in the next survey round. RESULTS: The first round included 82 statements with seven substatements. Sixty-five people (84% response rate) completed survey round 1 leading to 62 statements and four substatements being accepted. Fifty-six people responded to survey round 2, and consensus was achieved for all remaining statements. CONCLUSION: The accepted statements are included within the CPG and provide recommendations about who can benefit from FES and how they can be optimally supported through FES service provision. As such the CPG will support advocacy for, and optimal design of, FES services.

Is functional electrical stimulation effective in improving walking in adults with lower limb impairment due to an upper motor neuron lesion? An umbrella review.

PURPOSE: To conduct an umbrella review of systematic reviews on functional electrical stimulation (FES) to improve walking in adults with an upper motor neuron lesion. METHODS: Five electronic databases were searched, focusing on the effect of FES on walking. The methodological quality of reviews was evaluated using AMSTAR2 and certainty of evidence was established through the GRADE approach. RESULTS: The methodological quality of the 24 eligible reviews (stroke, n = 16; spinal cord injury (SCI), n = 5; multiple sclerosis (MS); n = 2; mixed population, n = 1) ranged from critically low to high. Stroke reviews concluded that FES improved walking speed through an orthotic (immediate) effect and had a therapeutic benefit (i.e., over time) compared to usual care (low certainty evidence). There was low-to-moderate certainty evidence that FES was no better or worse than an Ankle Foot Orthosis regarding walking speed post 6 months. MS reviews concluded that FES had an orthotic but no therapeutic effect on walking. SCI reviews concluded that FES with or without treadmill training improved speed but combined with an orthosis was no better than orthosis alone. FES may improve quality of life and reduce falls in MS and stroke populations. CONCLUSION: FES has orthotic and therapeutic benefits. Certainty of evidence was low-to-moderate, mostly due to high risk of bias, low sample sizes, and wide variation in outcome measures. Future trials must be of higher quality, use agreed outcome measures, including measures other than walking speed, and examine the effects of FES for adults with cerebral palsy, traumatic and acquired brain injury, and Parkinson's disease.

A pilot cluster randomised controlled trial, of an IMPlicit learning approach versus standard care, on recovery of mobility following stroke (IMPS).

OBJECTIVES: To evaluate the delivery of rehabilitation using implicit motor learning principles in an acute stroke setting. DESIGN: Pilot, assessor-blind, cluster randomised controlled trial with nested qualitative evaluation. SETTING: Eight inpatient stroke units, UK. PARTICIPANTS: People within 14 days of stroke onset, presenting with lower limb hemiplegia. INTERVENTIONS: Participants at control clusters received usual care. Participants at intervention clusters received rehabilitation using an Implicit Learning Approach (ILA); primarily consisting of reduced frequency instructions/feedback, and promotion of an external focus of attention. Video recording was used to understand the ability of intervention site therapists to adhere to the implicit learning principles, and to compare differences between groups. MEASURES: Ability to recruit and retain clusters/participants; suitability and acceptability of data collection processes; appropriateness of fidelity monitoring methods; and appropriateness of chosen outcome measures. RESULTS: Eight stroke units participated, with four assigned to each group (intervention/control). Fifty-one participants were enrolled (intervention group 21; control group 30). Mean time since stroke was 6 days (SD 3.42; 0-14); mean age was 73 years (SD 14, 25-94). Of those approached to take part, 72% agreed. We found clear differences between groups with respect to the frequency and type of instructional statement. The ILA was acceptable to both patients and therapists. CONCLUSION: It is feasible to evaluate the application and effectiveness of motor learning principles within acute stroke rehabilitation, using a cluster randomised design. A larger study is required to evaluate the benefits of each approach; we provide a range of sample size estimates required for this.

The effect of time spent in rehabilitation on activity limitation and impairment after stroke.

BACKGROUND: Stroke affects millions of people every year and is a leading cause of disability, resulting in significant financial cost and reduction in quality of life. Rehabilitation after stroke aims to reduce disability by facilitating recovery of impairment, activity, or participation. One aspect of stroke rehabilitation that may affect outcomes is the amount of time spent in rehabilitation, including minutes provided, frequency (i.e. days per week of rehabilitation), and duration (i.e. time period over which rehabilitation is provided). Effect of time spent in rehabilitation after stroke has been explored extensively in the literature, but findings are inconsistent. Previous systematic reviews with meta-analyses have included studies that differ not only in the amount provided, but also type of rehabilitation. OBJECTIVES: To assess the effect of 1. more time spent in the same type of rehabilitation on activity measures in people with stroke; 2. difference in total rehabilitation time (in minutes) on recovery of activity in people with stroke; and 3. rehabilitation schedule on activity in terms of: a. average time (minutes) per week undergoing rehabilitation, b. frequency (number of sessions per week) of rehabilitation, and c. total duration of rehabilitation. SEARCH METHODS: We searched the Cochrane Stroke Group trials register, CENTRAL, MEDLINE, Embase, eight other databases, and five trials registers to June 2021. We searched reference lists of identified studies, contacted key authors, and undertook reference searching using Web of Science Cited Reference Search. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of adults with stroke that compared different amounts of time spent, greater than zero, in rehabilitation (any non-pharmacological, non-surgical intervention aimed to improve activity after stroke). Studies varied only in the amount of time in rehabilitation between experimental and control conditions. Primary outcome was activities of daily living (ADLs); secondary outcomes were activity measures of upper and lower limbs, motor impairment measures of upper and lower limbs, and serious adverse events (SAE)/death. DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies, extracted data, assessed methodological quality using the Cochrane RoB 2 tool, and assessed certainty of the evidence using GRADE. For continuous outcomes using different scales, we calculated pooled standardised mean difference (SMDs) and 95% confidence intervals (CIs). We expressed dichotomous outcomes as risk ratios (RR) with 95% CIs. MAIN RESULTS: The quantitative synthesis of this review comprised 21 parallel RCTs, involving analysed data from 1412 participants.  Time in rehabilitation varied between studies. Minutes provided per week were 90 to 1288. Days per week of rehabilitation were three to seven. Duration of rehabilitation was two weeks to six months. Thirteen studies provided upper limb rehabilitation, five general rehabilitation, two mobilisation training, and one lower limb training. Sixteen studies examined participants in the first six months following stroke; the remaining five included participants more than six months poststroke. Comparison of stroke severity or level of impairment was limited due to variations in measurement. The risk of bias assessment suggests there were issues with the methodological quality of the included studies. There were 76 outcome-level risk of bias assessments: 15 low risk, 37 some concerns, and 24 high risk. When comparing groups that spent more time versus less time in rehabilitation immediately after intervention, we found no difference in rehabilitation for ADL outcomes (SMD 0.13, 95% CI -0.02 to 0.28; P = 0.09; I2 = 7%; 14 studies, 864 participants; very low-certainty evidence), activity measures of the upper limb (SMD 0.09, 95% CI -0.11 to 0.29; P = 0.36; I2 = 0%; 12 studies, 426 participants; very low-certainty evidence), and activity measures of the lower limb (SMD 0.25, 95% CI -0.03 to 0.53; P = 0.08; I2 = 48%; 5 studies, 425 participants; very low-certainty evidence). We found an effect in favour of more time in rehabilitation for motor impairment measures of the upper limb (SMD 0.32, 95% CI 0.06 to 0.58; P = 0.01; I2 = 10%; 9 studies, 287 participants; low-certainty evidence) and of the lower limb (SMD 0.71, 95% CI 0.15 to 1.28; P = 0.01; 1 study, 51 participants; very low-certainty evidence). There were no intervention-related SAEs. More time in rehabilitation did not affect the risk of SAEs/death (RR 1.20, 95% CI 0.51 to 2.85; P = 0.68; I2 = 0%; 2 studies, 379 participants; low-certainty evidence), but few studies measured these outcomes. Predefined subgroup analyses comparing studies with a larger difference of total time spent in rehabilitation between intervention groups to studies with a smaller difference found greater improvements for studies with a larger difference. This was statistically significant for ADL outcomes (P = 0.02) and activity measures of the upper limb (P = 0.04), but not for activity measures of the lower limb (P = 0.41) or motor impairment measures of the upper limb (P = 0.06). AUTHORS' CONCLUSIONS: An increase in time spent in the same type of rehabilitation after stroke results in little to no difference in meaningful activities such as activities of daily living and activities of the upper and lower limb but a small benefit in measures of motor impairment (low- to very low-certainty evidence for all findings). If the increase in time spent in rehabilitation exceeds a threshold, this may lead to improved outcomes. There is currently insufficient evidence to recommend a minimum beneficial daily amount in clinical practice. The findings of this study are limited by a lack of studies with a significant contrast in amount of additional rehabilitation provided between control and intervention groups. Large, well-designed, high-quality RCTs that measure time spent in all rehabilitation activities (not just interventional) and provide a large contrast (minimum of 1000 minutes) in amount of rehabilitation between groups would provide further evidence for effect of time spent in rehabilitation.

European evidence-based recommendations for clinical assessment of upper limb in neurorehabilitation (CAULIN): data synthesis from systematic reviews, clinical practice guidelines and expert consensus.

BACKGROUND: Technology-supported rehabilitation can help alleviate the increasing need for cost-effective rehabilitation of neurological conditions, but use in clinical practice remains limited. Agreement on a core set of reliable, valid and accessible outcome measures to assess rehabilitation outcomes is needed to generate strong evidence about effectiveness of rehabilitation approaches, including technologies. This paper collates and synthesizes a core set from multiple sources; combining existing evidence, clinical practice guidelines and expert consensus into European recommendations for Clinical Assessment of Upper Limb In Neurorehabilitation (CAULIN). METHODS: Data from systematic reviews, clinical practice guidelines and expert consensus (Delphi methodology) were systematically extracted and synthesized using strength of evidence rating criteria, in addition to recommendations on assessment procedures. Three sets were defined: a core set: strong evidence for validity, reliability, responsiveness and clinical utility AND recommended by at least two sources; an extended set: strong evidence OR recommended by at least two sources and a supplementary set: some evidence OR recommended by at least one of the sources. RESULTS: In total, 12 measures (with primary focus on stroke) were included, encompassing body function and activity level of the International Classification of Functioning and Health. The core set recommended for clinical practice and research: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT); the extended set recommended for clinical practice and/or clinical research: kinematic measures, Box and Block Test (BBT), Chedoke Arm Hand Activity Inventory (CAHAI), Wolf Motor Function Test (WMFT), Nine Hole Peg Test (NHPT) and ABILHAND; the supplementary set recommended for research or specific occasions: Motricity Index (MI); Chedoke-McMaster Stroke Assessment (CMSA), Stroke Rehabilitation Assessment Movement (STREAM), Frenchay Arm Test (FAT), Motor Assessment Scale (MAS) and body-worn movement sensors. Assessments should be conducted at pre-defined regular intervals by trained personnel. Global measures should be applied within 24 h of hospital admission and upper limb specific measures within 1 week. CONCLUSIONS: The CAULIN recommendations for outcome measures and assessment procedures provide a clear, simple, evidence-based three-level structure for upper limb assessment in neurological rehabilitation. Widespread adoption and sustained use will improve quality of clinical practice and facilitate meta-analysis, critical for the advancement of technology-supported neurorehabilitation.

Concurrent Validity of a Novel Wireless Inertial Measurement System for Assessing Trunk Impairment in People with Stroke.

Background: The Trunk Impairment Scale (TIS) is recommended for clinical research use to assess trunk impairment post-stroke. However, it is observer-dependent and neglects the quality of trunk movements. This study proposes an instrumented TIS (iTIS) using the Valedo system, comprising portable inertial sensors, as an objective measure of trunk impairment post-stroke. Objective: This study investigates the concurrent and discriminant ability of the iTIS in chronic stroke participants. Method: Forty participants (20 with chronic stroke, 20 healthy, age-matched) were assessed using the TIS and iTIS simultaneously. A Spearman rank correlation coefficient was used to examine concurrent validity. A ROC curve was used to determine whether the iTIS could distinguish between stroke participants with and without trunk impairment. Results: A moderate relationship was found between the observed iTIS parameters and the clinical scores, supporting the concurrent validity of the iTIS. The small sample size meant definitive conclusions could not be drawn about the parameter differences between stroke groups (participants scoring zero and one on the clinical TIS) and the parameter cut-off points. Conclusion: The iTIS can detect small changes in trunk ROM that cannot be observed clinically. The iTIS has important implications for objective assessments of trunk impairment in clinical practice.

The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study.

BACKGROUND: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our theory is that greater neurological recovery occurs when electrical stimulation of peripheral nerves is combined with voluntary effort. In this pilot study, we investigated the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort is encouraged by virtual reality biofeedback during FES cycling. METHODS: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) were recruited and completed 12-sessions of iCycle training. Function was assessed before and after training using the bilateral International Standards for Neurological Classification of SCI (ISNC-SCI) motor score, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10 m-walk test. Power output (PO) was measured during all training sessions. RESULTS: Two of the 6 participants with chronic injuries, and 4 of the 5 participants with sub-acute injuries, showed improvements in ISNC-SCI motor score > 8 points. Median (IQR) improvements were 3.5 (6.8) points for participants with a chronic SCI, and 8.0 (6.0) points for those with sub-acute SCI. Improvements were unrelated to other measured variables (age, time since injury, baseline ISNC-SCI motor score, baseline voluntary PO, time spent training and stimulation amplitude; p > 0.05 for all variables). Five out of 11 participants showed moderate improvements in voluntary cycling PO, which did not correlate with changes in ISNC-SCI motor score. Improvement in PO during cycling was positively correlated with baseline voluntary PO (R2 = 0.50; p < 0.05), but was unrelated to all other variables (p > 0.05). The iCycle was not suitable for participants who were too weak to generate a detectable voluntary torque or whose effort resulted in a negative torque. CONCLUSIONS: Improved ISNC-SCI motor scores in chronic participants may be attributable to the iCycle training. In sub-acute participants, early spontaneous recovery and changes due to iCycle training could not be distinguished. The iCycle is an innovative progression from existing FES cycling systems, and positive results should be verified in an adequately powered controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03834324. Registered 06 February 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03834324. Protocol V03, dated 06.08.2015.

Telehealth, Wearable Sensors, and the Internet: Will They Improve Stroke Outcomes Through Increased Intensity of Therapy, Motivation, and Adherence to Rehabilitation Programs?

BACKGROUND AND PURPOSE: Stroke, predominantly a condition of older age, is a major cause of acquired disability in the global population and puts an increasing burden on health care resources. Clear evidence for the importance of intensity of therapy in optimizing functional outcomes is found in animal models, supported by neuroimaging and behavioral research, and strengthened by recent meta-analyses from multiple clinical trials. However, providing intensive therapy using conventional treatment paradigms is expensive and sometimes not feasible because of social and environmental factors. This article addresses the need for cost-effective increased intensity of practice and suggests potential benefits of telehealth (TH) as an innovative model of care in physical therapy. SUMMARY OF KEY POINTS: We provide an overview of TH and present evidence that a web-supported program, used in conjunction with constraint-induced therapy (CIT), can increase intensity and adherence to a rehabilitation regimen. The design and feasibility testing of this web-based program, "LifeCIT," is presented. We describe how wearable sensors can monitor activity and provide feedback to patients and therapists. The methodology for the development of a wearable device with embedded inertial and mechanomyographic sensors, algorithms to classify functional movement, and a graphical user interface to present meaningful data to patients to support a home exercise program is explained. RECOMMENDATIONS FOR CLINICAL PRACTICE: We propose that wearable sensor technologies and TH programs have the potential to provide most-effective, intensive, home-based stroke rehabilitation.

Evaluation of upper extremity neurorehabilitation using technology: a European Delphi consensus study within the EU COST Action Network on Robotics for Neurorehabilitation.

BACKGROUND: The need for cost-effective neurorehabilitation is driving investment into technologies for patient assessment and treatment. Translation of these technologies into clinical practice is limited by a paucity of evidence for cost-effectiveness. Methodological issues, including lack of agreement on assessment methods, limit the value of meta-analyses of trials. In this paper we report the consensus reached on assessment protocols and outcome measures for evaluation of the upper extremity in neurorehabilitation using technology. The outcomes of this research will be part of the development of European guidelines. METHODS: A rigorous, systematic and comprehensive modified Delphi study incorporated questions and statements generation, design and piloting of consensus questionnaire and five consensus experts groups consisting of clinicians, clinical researchers, non-clinical researchers, and engineers, all with working experience of neurological assessments or technologies. For data analysis, two major groups were created: i) clinicians (e.g., practicing therapists and medical doctors) and ii) researchers (clinical and non-clinical researchers (e.g. movement scientists, technology developers and engineers). RESULTS: Fifteen questions or statements were identified during an initial ideas generation round, following which the questionnaire was designed and piloted. Subsequently, questions and statements went through five consensus rounds over 20 months in four European countries. Two hundred eight participants: 60 clinicians (29 %), 35 clinical researchers (17 %), 77 non-clinical researchers (37 %) and 35 engineers (17 %) contributed. At each round questions and statements were added and others removed. Consensus (≥69 %) was obtained for 22 statements on i) the perceived importance of recommendations; ii) the purpose of measurement; iii) use of a minimum set of measures; iv) minimum number, timing and duration of assessments; v) use of technology-generated assessments and the restriction of clinical assessments to validated outcome measures except in certain circumstances for research. CONCLUSIONS: Consensus was reached by a large international multidisciplinary expert panel on measures and protocols for assessment of the upper limb in research and clinical practice. Our results will inform the development of best practice for upper extremity assessment using technologies, and the formulation of evidence-based guidelines for the evaluation of upper extremity neurorehabilitation.

Physical rehabilitation for critical illness myopathy and neuropathy.

BACKGROUND: Intensive care unit (ICU) acquired or generalised weakness due to critical illness myopathy (CIM) and polyneuropathy (CIP) are major causes of chronically impaired motor function that can affect activities of daily living and quality of life. Physical rehabilitation of those affected might help to improve activities of daily living. OBJECTIVES: Our primary objective was to assess the effects of physical rehabilitation therapies and interventions for people with CIP and CIM in improving activities of daily living such as walking, bathing, dressing and eating. Secondary objectives were to assess effects on muscle strength and quality of life, and to assess adverse effects of physical rehabilitation. SEARCH METHODS: On 16 July 2014 we searched the Cochrane Neuromuscular Disease Group Specialized Register and on 14 July 2014 we searched CENTRAL, MEDLINE, EMBASE and CINAHL Plus. In July 2014, we searched the Physiotherapy Evidence Database (PEDro, http://www.pedro.org.au/) and three trials registries for ongoing trials and further data about included studies. There were no language restrictions. We also handsearched relevant conference proceedings and screened reference lists to identify further trials. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs), quasi-RCTs and randomised controlled cross-over trials of any rehabilitation intervention in people with acquired weakness syndrome due to CIP/CIM. DATA COLLECTION AND ANALYSIS: We would have extracted data, assessed the risk of bias and classified the quality of evidence for outcomes in duplicate, according to the standard procedures of The Cochrane Collaboration. Outcome data collection would have been for activities of daily living (for example, mobility, walking, transfers and self care). Secondary outcomes included muscle strength, quality of life and adverse events. MAIN RESULTS: The search strategy retrieved 3587 references. After examination of titles and abstracts, we retrieved the full text of 24 potentially relevant studies. None of these studies met the inclusion criteria of our review. No data were suitable to be included in a meta-analysis. AUTHORS' CONCLUSIONS: There are no published RCTs or quasi-RCTs that examine whether physical rehabilitation interventions improve activities of daily living for people with CIP and CIM. Large RCTs, which are feasible, need to be conducted to explore the role of physical rehabilitation interventions for people with CIP and CIM.

Translation of evidence-based Assistive Technologies into stroke rehabilitation: users' perceptions of the barriers and opportunities.

BACKGROUND: Assistive Technologies (ATs), defined as "electrical or mechanical devices designed to help people recover movement", demonstrate clinical benefits in upper limb stroke rehabilitation; however translation into clinical practice is poor. Uptake is dependent on a complex relationship between all stakeholders. Our aim was to understand patients', carers' (P&Cs) and healthcare professionals' (HCPs) experience and views of upper limb rehabilitation and ATs, to identify barriers and opportunities critical to the effective translation of ATs into clinical practice. This work was conducted in the UK, which has a state funded healthcare system, but the findings have relevance to all healthcare systems. METHODS: Two structurally comparable questionnaires, one for P&Cs and one for HCPs, were designed, piloted and completed anonymously. Wide distribution of the questionnaires provided data from HCPs with experience of stroke rehabilitation and P&Cs who had experience of stroke. Questionnaires were designed based on themes identified from four focus groups held with HCPs and P&Cs and piloted with a sample of HCPs (N = 24) and P&Cs (N = 8). Eight of whom (four HCPs and four P&Cs) had been involved in the development. RESULTS: 292 HCPs and 123 P&Cs questionnaires were analysed. 120 (41%) of HCP and 79 (64%) of P&C respondents had never used ATs. Most views were common to both groups, citing lack of information and access to ATs as the main reasons for not using them. Both HCPs (N = 53 [34%]) and P&C (N = 21 [47%]) cited Functional Electrical Stimulation (FES) as the most frequently used AT. Research evidence was rated by HCPs as the most important factor in the design of an ideal technology, yet ATs they used or prescribed were not supported by research evidence. P&Cs rated ease of set-up and comfort more highly. CONCLUSION: Key barriers to translation of ATs into clinical practice are lack of knowledge, education, awareness and access. Perceptions about arm rehabilitation post-stroke are similar between HCPs and P&Cs. Based on our findings, improvements in AT design, pragmatic clinical evaluation, better knowledge and awareness and improvement in provision of services will contribute to better and cost-effective upper limb stroke rehabilitation.

The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study.

BACKGROUND: Functional electrical stimulation (FES) during repetitive practice of everyday tasks can facilitate recovery of upper limb function following stroke. Reduction in impairment is strongly associated with how closely FES assists performance, with advanced iterative learning control (ILC) technology providing precise upper-limb assistance. The aim of this study is to investigate the feasibility of extending ILC technology to control FES of three muscle groups in the upper limb to facilitate functional motor recovery post-stroke. METHODS: Five stroke participants with established hemiplegia undertook eighteen intervention sessions, each of one hour duration. During each session FES was applied to the anterior deltoid, triceps, and wrist/finger extensors to assist performance of functional tasks with real-objects, including closing a drawer and pressing a light switch. Advanced model-based ILC controllers used kinematic data from previous attempts at each task to update the FES applied to each muscle on the subsequent trial. This produced stimulation profiles that facilitated accurate completion of each task while encouraging voluntary effort by the participant. Kinematic data were collected using a Microsoft Kinect, and mechanical arm support was provided by a SaeboMAS. Participants completed Fugl-Meyer and Action Research Arm Test clinical assessments pre- and post-intervention, as well as FES-unassisted tasks during each intervention session. RESULTS: Fugl-Meyer and Action Research Arm Test scores both significantly improved from pre- to post-intervention by 4.4 points. Improvements were also found in FES-unassisted performance, and the amount of arm support required to successfully perform the tasks was reduced. CONCLUSIONS: This feasibility study indicates that technology comprising low-cost hardware fused with advanced FES controllers accurately assists upper limb movement and may reduce upper limb impairments following stroke.

Multicentre pilot randomised control trial of a self-directed exergaming intervention for poststroke upper limb rehabilitation: research protocol.

INTRODUCTION: Technology-facilitated, self-directed upper limb (UL) rehabilitation, as an adjunct to conventional care, could enhance poststroke UL recovery compared with conventional care alone, without imposing additional resource burden. The proposed pilot randomised controlled trial (RCT) aims to assess whether stroke survivors will engage in self-directed UL training, explore factors associated with intervention adherence and evaluate the study design for an RCT testing the efficacy of a self-directed exer-gaming intervention for UL recovery after stroke. METHODS AND ANALYSIS: This is a multicentre, internal pilot RCT; parallel design, with nested qualitative methods. The sample will consist of stroke survivors with UL paresis, presenting within the previous 30 days. Participants randomised to the intervention group will be trained to use an exergaming device and will be supported to adopt this as part of their self-directed rehabilitation (ie, without formal support/supervision) for a 3-month period. The primary outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6 months poststroke. Secondary outcomes are the Action Research Arm Test (ARAT), the Barthel Index and the Modified Rankin Scale. Assessment time points will be prior to randomisation (0-1 month poststroke), 3 months and 6 months poststroke. A power calculation to inform sample size required for a definitive RCT will be conducted using FM-UE data from the sample across 0-6 months time points. Semistructured qualitative interviews will examine factors associated with intervention adoption. Reflexive thematic analysis will be used to code qualitative interview data and generate key themes associated with intervention adoption. ETHICS AND DISSEMINATION: The study protocol (V.1.9) was granted ethical approval by the Health Research Authority, Health and Care Research Wales, and the London- Harrow Research Ethics Committee (ref. 21/LO/0054) on 19 May 2021. Trial results will be submitted for publication in peer-reviewed journals, presented at national and international stroke meetings and conferences and disseminated among stakeholder communities. TRIAL REGISTRATION NUMBER: NCT04475692.

Standardized measurement of balance and mobility post-stroke: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

BACKGROUND: Mobility is a key priority for stroke survivors. Worldwide consensus of standardized outcome instruments for measuring mobility recovery after stroke is an essential milestone to optimize the quality of stroke rehabilitation and recovery studies and to enable data synthesis across trials. METHODS: Using a standardized methodology, which involved convening of 13 worldwide experts in the field of mobility rehabilitation, consensus was established through an a priori defined survey-based approach followed by group discussions. The group agreed on balance- and mobility-related definitions and recommended a core set of outcome measure instruments for lower extremity motor function, balance and mobility, biomechanical metrics, and technologies for measuring quality of movement. RESULTS: Selected measures included the Fugl-Meyer Motor Assessment lower extremity subscale for motor function, the Trunk Impairment Scale for sitting balance, and the Mini Balance Evaluation System Test (Mini-BESTest) and Berg Balance Scale (BBS) for standing balance. The group recommended the Functional Ambulation Category (FAC, 0-5) for walking independence, the 10-meter Walk Test (10 mWT) for walking speed, the 6-Minute Walk Test (6 MWT) for walking endurance, and the Dynamic Gait Index (DGI) for complex walking. An FAC score of less than three should be used to determine the need for an additional standing test (FAC < 3, add BBS to Mini-BESTest) or the feasibility to assess walking (FAC < 3, 10 mWT, 6 MWT, and DGI are "not testable"). In addition, recommendations are given for prioritized kinetic and kinematic metrics to be investigated that measure recovery of movement quality of standing balance and walking, as well as for assessment protocols and preferred equipment to be used. CONCLUSIONS: The present recommendations of measures, metrics, technology, and protocols build on previous consensus meetings of the International Stroke Recovery and Rehabilitation Alliance to guide the research community to improve the validity and comparability between stroke recovery and rehabilitation studies as a prerequisite for building high-quality, standardized "big data" sets. Ultimately, these recommendations could lead to high-quality, participant-specific data sets to aid the progress toward precision medicine in stroke rehabilitation.

Standardized measurement of balance and mobility post-stroke: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

BACKGROUND: Mobility is a key priority for stroke survivors. Worldwide consensus of standardized outcome instruments for measuring mobility recovery after stroke is an essential milestone to optimize the quality of stroke rehabilitation and recovery studies and to enable data synthesis across trials. METHODS: Using a standardized methodology, which involved convening of 13 worldwide experts in the field of mobility rehabilitation, consensus was established through an a priori defined survey-based approach followed by group discussions. The group agreed on balance- and mobility-related definitions and recommended a core set of outcome measure instruments for lower extremity motor function, balance and mobility, biomechanical metrics, and technologies for measuring quality of movement. RESULTS: Selected measures included the Fugl-Meyer Motor Assessment lower extremity subscale for motor function, the Trunk Impairment Scale for sitting balance, and the Mini Balance Evaluation System Test (Mini-BESTest) and Berg Balance Scale (BBS) for standing balance. The group recommended the Functional Ambulation Category (FAC, 0-5) for walking independence, the 10-meter Walk Test (10 mWT) for walking speed, the 6-Minute Walk Test (6 MWT) for walking endurance, and the Dynamic Gait Index (DGI) for complex walking. An FAC score of less than three should be used to determine the need for an additional standing test (FAC < 3, add BBS to Mini-BESTest) or the feasibility to assess walking (FAC < 3, 10 mWT, 6 MWT, and DGI are "not testable"). In addition, recommendations are given for prioritized kinetic and kinematic metrics to be investigated that measure recovery of movement quality of standing balance and walking, as well as for assessment protocols and preferred equipment to be used. CONCLUSIONS: The present recommendations of measures, metrics, technology, and protocols build on previous consensus meetings of the International Stroke Recovery and Rehabilitation Alliance to guide the research community to improve the validity and comparability between stroke recovery and rehabilitation studies as a prerequisite for building high-quality, standardized "big data" sets. Ultimately, these recommendations could lead to high-quality, participant-specific data sets to aid the progress toward precision medicine in stroke rehabilitation.

Assistive technologies after stroke: self-management or fending for yourself? A focus group study.

BACKGROUND: Assistive Technologies, defined as "electrical or mechanical devices designed to help people recover movement" have demonstrated clinical benefits in upper-limb stroke rehabilitation. Stroke services are becoming community-based and more reliant on self-management approaches. Assistive technologies could become important tools within self-management, however, in practice, few people currently use assistive technologies. This study investigated patients', family caregivers and health professionals' experiences and perceptions of stroke upper-limb rehabilitation and assistive technology use and identified the barriers and facilitators to their use in supporting stroke self-management. METHODS: A three-day exhibition of assistive technologies was attended by 204 patients, family caregivers/friends and health professionals. Four focus groups were conducted with people purposively sampled from exhibition attendees. They included i) people with stroke who had used assistive technologies (n = 5), ii) people with stroke who had not used assistive technologies (n = 6), iii) family caregivers (n = 5) and iv) health professionals (n = 6). The audio-taped focus groups were facilitated by a moderator and observer. All participants were asked to discuss experiences, strengths, weaknesses, barriers and facilitators to using assistive technologies. Following transcription, data were analysed using thematic analysis. RESULTS: All respondents thought assistive technologies had the potential to support self-management but that this opportunity was currently unrealised. All respondents considered assistive technologies could provide a home-based solution to the need for high intensity upper-limb rehabilitation. All stakeholders also reported significant barriers to assistive technology use, related to i) device design ii) access to assistive technology information and iii) access to assistive technology provision. The lack of and need for a coordinated system for assistive technology provision was apparent. A circular limitation of lack of evidence in clinical settings, lack of funded provision, lack of health professional knowledge about assistive technologies and confidence in prescribing them leading to lack of assistive technology service provision meant that often patients either received no assistive technologies or they and/or their family caregivers liaised directly with manufacturers without any independent expert advice. CONCLUSIONS: Considerable systemic barriers to realising the potential of assistive technologies in upper-limb stroke rehabilitation were reported. Attention needs to be paid to increasing evidence of assistive technology effectiveness and develop clinical service provision. Device manufacturers, researchers, health professionals, service funders and people with stroke and family caregivers need to work creatively and collaboratively to develop new funding models, improve device design and increase knowledge and training in assistive technology use.

Functional electrical stimulation with exercises for standing balance and weight transfer in acute stroke patients: a feasibility randomized controlled trial.

OBJECTIVES: To test parameters needed for the design of a larger trial including the following: 1) identifying eligible participants, recruitment, and retention rates; 2) the feasibility and acceptability of delivering functional electrical stimulation (FES) to the gluteus maximus and quadriceps femoris for acute stroke patients in a hospital rehabilitation setting; 3) the outcome measures; 4) obtaining initial estimates of effect size; and 5) clarifying the relevant control group. MATERIALS AND METHODS: Twenty-one people with acute stroke-mean age = 68 (min to max: 33-87) years; weeks postonset = 4.6 (min to max: 1-14)-were randomized to three groups to receive two weeks of balance training with FES, balance training alone, or usual care. Symmetry in normal standing, weight transfer onto the affected limb, balance, mobility, and speed of walking were assessed before, shortly after the end of training, and two weeks later by a blinded assessor. RESULTS: 1) FES was successfully delivered but not with the planned eight sessions; 2) no trends in favor of FES were found; and 3) 4% of those screened took part but approaching 20% might be recruited in the future, no single outcome measure was suitable for all participants, and more routine physiotherapy was delivered to the control group. CONCLUSIONS: FES is feasible in this patient group but further feasibility and definitive trials are required.

Principles into Practice: An Observational Study of Physiotherapists use of Motor Learning Principles in Stroke Rehabilitation.

OBJECTIVE(S): To describe a) how motor learning principles are applied during post stroke physiotherapy, with a focus on lower limb rehabilitation; and b) the context in which these principles are used, in relation to patient and/or task characteristics. DESIGN: Direct non-participation observation of routine physiotherapy sessions, with data collected via video recording. A structured analysis matrix and pre-agreed definitions were used to identify, count and record: type of activity; repetitions; instructional and feedback statements (frequency and type); strategies such as observational learning and augmented feedback. Data was visualised using scatter plots, and analysed descriptively. SETTING: 6 UK Stroke Units PARTICIPANTS: 89 therapy sessions were observed, involving 55 clinicians and 57 patients. RESULTS: Proportion of time spent active within each session ranged from 26% to 98% (mean 85, SD 19). The frequency of task repetition varied widely, with a median of 3.7 repetitions per minute (IQR 2.1-8.6). Coaching statements were common (mean 6.46 per minute), with 52% categorised as instructions, 14% as feedback, and 34% as verbal cues/motivational statements. 13% of instructions and 6% of feedback statements were externally focussed. Examining the use of different coaching behaviours in relation to patient characteristics found no associations. Overall, practice varied widely across the dataset. CONCLUSIONS: To optimise the potential for motor skill learning, therapists must manipulate features of their coaching language (what they say, how much and when) and practice design (type, number, difficulty and variability of task). There is an opportunity to implement motor learning principles more consistently, to benefit motor skill recovery following stroke. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT03792126). CONTRIBUTION OF THE PAPER.

A nation-wide survey exploring the views of current and future use of functional electrical stimulation in spinal cord injury.

PURPOSE: Functional electrical stimulation (FES) can be effective in assisting physical and psychosocial difficulties experienced by people with spinal cord injury. Perceived benefits and barriers of the current and future use of FES within the wider spinal cord injury community is currently unknown. The main objective of this research was to explore the spinal cord injury community's views of the use of FES to decrease disability in rehabilitation programmes. MATERIALS AND METHODS: An online and paper questionnaire was distributed to people with spinal cord injury, health care professionals and researchers working in spinal cord injury settings in the United Kingdom. RESULTS: A total of 299 participants completed the survey (152 people with spinal cord injury, 141 health care professionals and 6 researchers). Common views between groups identified were: (1) FES can be beneficial in improving physical and psychosocial aspects and that (2) adequate support and training for FES application was provided to users. Barriers to FES use included a lack of staff time and training, financial cost and availability of the equipment. Sixty three percent of non-users felt they would use FES in the future if they had the opportunity. CONCLUSIONS: Users' views were important in identifying that FES application can be beneficial for people with spinal cord injury but also has some resourceful barriers. In order to increase use, future research should focus on reducing the cost of FES clinical service and also address implementation of awareness and training programmes within spinal units and community rehabilitation settings.IMPLICATIONS FOR REHABILITATIONUsers of functional electrical stimulation think that it is beneficial for improving physical and psychosocial limitations after spinal cord injuryBarriers to FES use include a lack of staff time and training, financial cost and availability of the equipment have been suggested by people with spinal cord injury and health care professionalsEducation and implementation programs for health care professionals and people with spinal cord injury are now necessary to increase the awareness about functional electrical stimulation applicationReduction of FES cost could also increase its uptake in spinal cord injury clinical services.