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.

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.

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.

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.

Why do some people who had a stroke not receive the recommended 45 min of occupational therapy and physiotherapy? A Delphi study.

OBJECTIVES: To gain a consensus among therapists for reasons why a person who had a stroke may not receive the Royal College of Physicians' recommended minimum of 45 min of daily therapy. DESIGN: Three-round remote e-Delphi study. SETTING: National study, based in the UK. PARTICIPANTS: Occupational therapists and physiotherapists with experience of delivering therapy after stroke and awareness of the 45 min guideline. RESULTS: Forty-five therapists consented to participate in the study. Thirty-five (78%) completed round one, 29 of 35 (83%) completed round 2 and 26 of 29 (90%) completed round three. A consensus (75%) was reached for 32 statements. Reasons why a person may not receive 45 min were related to the suitability of the guideline for the individual (based on factors like therapy tolerance or medical status) or the capability of the service to provide the intervention. In addition to the statements for which there was a consensus, 32 concepts did not reach a consensus. Specifically, there was a lack of consensus concerning the suitability of the guideline for people receiving Early Supported Discharge (ESD) services and a lack of agreement about whether people who need more than 45 min of therapy actually receive it. CONCLUSION: Some people do not receive 45 min of therapy as they are considered unsuitable for it and some do not receive it due to services' inability to provide it. It is unclear which reasons for guideline non-achievement are most common. Future research should focus on why the guideline is not achieved in ESD, and why people who require more than 45 min may not receive it. This could contribute to practical guidance for therapists to optimise therapy delivery for people after stroke.

Why do some people with stroke not receive the recommended 45 min of occupational therapy and physiotherapy after stroke? A qualitative study using focus groups.

OBJECTIVES: To generate qualitative data on the views of Occupational Therapists and Physiotherapists about why people do not receive the Royal College of Physicians' recommended minimum of 45 minutes (min) of daily therapy after stroke, in order to inform a Delphi study. DESIGN: Focus group study. SETTING: Stroke services in the South of England. PARTICIPANTS: A total of nine participants, in two groups, including therapists covering inpatient and Early Supported Discharge (ESD) services with awareness of the 45 min guideline. RESULTS: Thematic analysis of focus group data identified five factors that influence the amount of therapy a person receives: The Person (with stroke), Individual Therapist, Stroke Multidisciplinary Team, the Organisation and the Guideline. Study findings suggest that the reasons why a person does not receive the therapy recommendation in inpatient and ESD services relate to either the suitability of the guideline for the person with stroke, or the ability of the service to deliver the guideline. CONCLUSION: This study provides evidence for possible reasons why some people do not receive a minimum of 45 minutes of therapy, 5 days per week, related to (1) the suitability of the guideline for people with stroke and (2) services' ability to deliver this amount of intervention. These two factors are related; therapists decide who should receive therapy and how much in the context of (a) resource availability and (b) people's need and the benefit they will experience. The study findings, combined with the findings from other studies, will be used to initiate a Delphi study, which will establish consensus among therapists regarding the reasons why some people do not receive the guideline amount of therapy.

Examining Usability, Acceptability, and Adoption of a Self-Directed, Technology-Based Intervention for Upper Limb Rehabilitation After Stroke: Cohort Study.

BACKGROUND: Upper limb (UL) recovery after stroke is strongly dependent upon rehabilitation dose. Rehabilitation technologies present pragmatic solutions to dose enhancement, complementing therapeutic activity within conventional rehabilitation, connecting clinicians with patients remotely, and empowering patients to drive their own recovery. To date, rehabilitation technologies have been poorly adopted. Understanding the barriers to adoption may shape strategies to enhance technology use and therefore increase rehabilitation dose, thus optimizing recovery potential. OBJECTIVE: We examined the usability, acceptability, and adoption of a self-directed, exercise-gaming technology within a heterogeneous stroke survivor cohort and investigated how stroke survivor characteristics, technology usability, and attitudes toward technology influenced adoption. METHODS: A feasibility study of a novel exercise-gaming technology for self-directed UL rehabilitation in early subacute stroke survivors (N=30) was conducted in an inpatient, acute hospital setting. Demographic and clinical characteristics were recorded; participants' performance in using the system (usability) was assessed using a 4-point performance rating scale (adapted from the Barthel index), and adherence with the system was electronically logged throughout the trial. The technology acceptance model was used to formulate a survey examining the acceptability of the system. Spearman rank correlations were used to examine associations between participant characteristics, user performance (usability), end-point technology acceptance, and intervention adherence (adoption). RESULTS: The technology was usable for 87% (n=26) of participants, and the overall technology acceptance rating was 68% (95% CI 56%-79%). Participants trained with the device for a median of 26 (IQR 16-31) minutes daily over an enrollment period of 8 (IQR 5-14) days. Technology adoption positively correlated with user performance (usability) (ρ=0.55; 95% CI 0.23-0.75; P=.007) and acceptability as well as domains of perceived usefulness (ρ=0.42; 95% CI 0.09-0.68; P=.03) and perceived ease of use (ρ=0.46; 95% CI 0.10-0.74; P=.02). Technology acceptance decreased with increased global stroke severity (ρ=-0.56; 95% CI -0.79 to -0.22; P=.007). CONCLUSIONS: This technology was usable and acceptable for the majority of the cohort, who achieved an intervention dose with technology-facilitated, self-directed UL training that exceeded conventional care norms. Technology usability and acceptability were determinants of adoption and appear to be mediated by stroke severity. The results demonstrate the importance of selecting technologies for stroke survivors on the basis of individual needs and abilities, as well as optimizing the accessibility of technologies for the target user group. Facilitating changes in stroke survivors' beliefs and attitudes toward rehabilitation technologies may enhance adoption. Further work is needed to understand how technology can be optimized to benefit those with more severe stroke.

Implementing functional electrical stimulation clinical practice guidelines to support mobility: A stakeholder consultation.

Functional Electrical Stimulation (FES) has been used to support mobility for people with upper motor neuron conditions such as stroke and multiple sclerosis for over 25 years. Recent development and publication of clinical practice guidelines (CPGs) provide evidence to guide clinical decision making for application of FES to improve mobility. Understanding key barriers to the implementation of these CPGs is a critical initial step necessary to create tailored knowledge translation strategies. A public involvement and engagement consultation was conducted with international stakeholders including researchers, clinicians and engineers working with FES to inform implementation strategies for CPG use internationally. Reflexive thematic analysis of the consultation transcripts revealed themes including inconsistent use of CPGs, barriers to implementation such as limited access to FES and low clinician confidence, and the need for a tiered education approach with ongoing support. Insights derived from this consultation will inform the development of knowledge translation strategies to support the next steps to implementing FES use for mobility.

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.

Task selection for a sensor-based, wearable, upper limb training device for stroke survivors: a multi-stage approach.

PURPOSE: Post-stroke survivors report that feedback helps to increase training motivation. A wearable system (M-MARK), comprising movement and muscle sensors and providing feedback when performing everyday tasks was developed. The objective reported here was to create an evidence-based set of upper-limb tasks for use with the system. MATERIALS AND METHODS: Data from two focus groups with rehabilitation professionals, ten interviews with stroke survivors and a review of assessment tests were synthesized. In a two-stage process, suggested tasks were screened to exclude non-tasks and complex activities. Remaining tasks were screened for suitability and entered into a categorization matrix. RESULTS: Of 83 suggestions, eight non-tasks, and 42 complex activities were rejected. Of the remaining 33 tasks, 15 were rejected: five required fine motor control; eight were too complex to standardize; one because the role of hemiplegic hand was not defined and one involved water. The review of clinical assessment tests found no additional tasks. Eleven were ultimately selected for testing with M-Mark. CONCLUSIONS: Using a task categorization matrix, a set of training tasks was systematically identified. There was strong agreement between data from the professionals, survivors and literature. The matrix populated by tasks has potential for wider use in upper-limb stroke rehabilitation. IMPLICATIONS FOR REHABILITATIONRehabilitation technologies that provide feedback on quantity and quality of movements can support independent home-based upper limb rehabilitation.Rehabilitation technology systems require a library of upper limb tasks at different levels for people with stroke and therapists to choose from.A user-defined and evidence-based set of upper limb tasks for use within a wearable sensor device system have been developed.

The importance of self-efficacy and negative affect for neurofeedback success for central neuropathic pain after a spinal cord injury.

EEG-based neurofeedback uses mental behaviours (MB) to enable voluntary self-modulation of brain activity, and has potential to relieve central neuropathic pain (CNP) after a spinal cord injury (SCI). This study aimed to understand neurofeedback learning and the relationship between MB and neurofeedback success. Twenty-five non-CNP participants and ten CNP participants received neurofeedback training (reinforcing 9-12 Hz; suppressing 4-8 Hz and 20-30 Hz) on four visits. Participants were interviewed about the MB they used after each visit. Questionnaires examined the following factors: self-efficacy, locus of control, motivation, and workload of neurofeedback. MB were grouped into mental strategies (a goal-directed mental action) and affect (emotional experience during neurofeedback). Successful non-CNP participants significantly used more imagination-related MS and reported more negative affect compared to successful CNP participants. However, no mental strategy was clearly associated with neurofeedback success. There was some association between the lack of success and negative affect. Self-efficacy was moderately correlated with neurofeedback success (r = < 0.587, p = < 0.020), whereas locus of control, motivation, and workload had low, non-significant correlations (r < 0.300, p > 0.05). Affect may be more important than mental strategies for a successful neurofeedback performance. Self-efficacy was associated with neurofeedback success, suggesting that increasing confidence in one's neurofeedback abilities may improve neurofeedback performance.

Longitudinal analysis of the recovery of trunk control and upper extremity following stroke: An individual growth curve approach.

BACKGROUND AND PURPOSE: Trunk control is thought to contribute to upper extremity function. It is unclear whether recovery of trunk control has an impact on the recovery of the upper extremity in people with stroke. This longitudinal study monitored the recovery of trunk control and upper extremity in the first 6 months following stroke. METHODS: Forty-five participants with stroke were assessed monthly for 6 months following stroke. Trunk control was assessed using the Trunk Impairment Scale (TIS); upper extremity impairment and function were assessed with the Fugl-Meyer (FMA) and Streamlined Wolf Motor Function Test (SWMFT) respectively. The SWMFT included the performance time (SWMFT-Time) and functional ability scale (SWMFT-FAS). The individual growth curve modeling was used to analyze the longitudinal data. RESULTS: The recovery curve of TIS, FMA, SWMFT-Time and SWMFT-FAS followed a quadratic trend, with the rate of recovery decreasing from the first to sixth month. As TIS score improved over time, FMA, SWMFT-Time and SWMFT-FAS improved in parallel with the TIS score. TIS at each time point was found to be a significant predictor of FMA, SWMFT-Time and SWMFT-FAS at 6 months post stroke. CONCLUSION: Our work has provided, for the first time, substantial evidence that the pattern of recovery of trunk control is similar to that of the recovery of upper extremity following stroke. In addition, this study provides evidence on which to design a prospective study to evaluate whether improvement in trunk control early post-stroke results in better long-term upper extremity function.

Development of lower limb training interventions that promote an external focus of attention in people with stroke: a modified Delphi survey.

OBJECTIVE: To produce guidance and validated examples of tasks that promote an external focus of attention, for use in lower limb rehabilitation in an inpatient stroke care setting. DESIGN: Electronic survey, using e-Delphi methodology. PARTICIPANTS: A multi-professional expert panel of 14 clinicians and researchers, with expertise in stroke rehabilitation and/or motor learning. METHOD: Each survey round consisted of two parts: 1) classification of specific exercise examples, shown using video and 2) the categorization of specific tratement adjuncts. The panel was asked to comment on: likely focus of attention of the performer; instructions that would promote an external focus of attention; and how the task set-up could be modified to promote an external focus of attention. Rounds 2 and 3 included a summary of results from the previous round, and revised/new examples. The panel were also asked to state their level of agreement with a series of statements that arose from the free text. Three rounds of survey were completed and the a priori threshold for agreement was set at 80%. RESULTS: Eighteen iterations of exercises were presented, and 12 were accepted as promoting an external focus of attention. In addition, six additional statements were generated based on open responses, leading to further specific guidance on facilitating an external focus of attention in clinical practice. CONCLUSIONS: Commonly used rehabilitation exercises can be adapted to promote an external focus of attention, by altering the therapist's use of instructions and/or altering the task set up. Treatment principles and examples of tasks that promote an external focus have been produced.

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.

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.

Self-Directed Exergaming for Stroke Upper Limb Impairment Increases Exercise Dose Compared to Standard Care.

Background. One of the strongest modifiable determinants of rehabilitation outcome is exercise dose. Technologies enabling self-directed exercise offer a pragmatic means to increase dose, but the extent to which they achieve this in unselected cohorts, under real-world constraints, is poorly understood. Objective. Here we quantify the exercise dose achieved by inpatient stroke survivors using an adapted upper limb (UL) exercise gaming (exergaming) device and compare this with conventional (supervised) therapy. Methods. Over 4 months, patients presenting with acute stroke and associated UL impairment were screened at a single stroke centre. Participants were trained in a single session and provided with the device for unsupervised use during their inpatient admission. Results. From 75 patients referred for inpatient UL therapy, we recruited 30 (40%), of whom 26 (35%) were able to use the device meaningfully with their affected UL. Over a median enrolment time of 8 days (IQR: 5-14), self-directed UL exercise duration using the device was 26 minutes per day (median; IQR: 16-31), in addition to 25 minutes daily conventional UL therapy (IQR: 12-34; same cohort plus standard care audit; joint n = 50); thereby doubling total exercise duration (51 minutes; IQR: 32-64) relative to standard care (Z = 4.0, P <.001). The device enabled 104 UL repetitions per day (IQR: 38-393), whereas conventional therapy achieved 15 UL repetitions per day (IQR: 11-23; Z = 4.3, P <.001). Conclusion. Self-directed adapted exergaming enabled participants in our stroke inpatient cohort to increase exercise duration 2-fold, and repetitions 8-fold, compared to standard care, without requiring additional professional supervision.

Instrumented trunk impairment scale (iTIS): A reliable measure of trunk impairment in the stroke population.

BACKGROUND: The Trunk Impairment Scale (TIS) is recommended for use in clinical research to assess trunk impairment post-stroke. However, it is observer dependent and does not consider the quality of trunk movement. To address these challenges, this study proposes an instrumented TIS (iTIS). OBJECTIVE: This study aims to investigate the intra-rater and inter-rater reliability of the iTIS in chronic stroke patients. METHOD: Trunk impairment was assessed in 20 patients with stroke using the iTIS Valedo system; three sensors were fixed to the skin on the sternum, L1 and S1 levels. Interclass correlation coefficients were used to assess the inter-rater and intra-rater reliability (between days) with 95% CI. RESULTS: Reliability for the dynamic subscale parameters was good to excellent (intra-rater ICC = 0.60-0.95; inter-rater ICC = 0.59-0.93); however, reliability for the coordination parameters was poor to good (intra-rater ICC = 0.05-0.72) and poor to excellent (inter-rater ICC = 0.04-0.78). CONCLUSION: The iTIS demonstrates an acceptable level of reliability for dynamic subscale measurement in research and clinical practice. Further studies could use larger sample sizes and improve the iTIS methodology by employing additional sensors on the limbs to detect compensatory movements.