A Systematic Review of Female Participation in Randomized Controlled Trials of Post-Stroke Upper Extremity Rehabilitation in Low- to Middle-Income Countries and High-Income Countries and Regions.

INTRODUCTION: Female participation is lower than males in both acute stroke and stroke rehabilitation trials. However, less is known about how female participation differs across countries and regions. This study aimed to assess the percentage of female participants in randomized controlled trials (RCTs) of post-stroke rehabilitation of upper extremity (UE) motor disorders in low-middle-income (LMICs) and high-income countries (HICs) as well as different high-income world regions. METHODS: CINAHL, Embase, PubMed, Scopus, and Web of Science were searched from 1960 to April 1, 2021. Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English; (2) ≥50% of participants were diagnosed with stroke; 3) included adults ≥18 years old; and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. Countries were divided into HICs and LMICs based on their growth national incomes. The HICs were further divided into the three high-income regions of North America, Europe, and Asia and Oceania. Data analysis was performed using SPSS and RStudio v.4.3.1. RESULTS: A total of 1,276 RCTs met inclusion criteria. Of them, 298 RCTs were in LMICs and 978 were in HICs. The percentage of female participants was significantly higher in HICs (39.5%) than LMICs (36.9%). Comparing high-income regions, there was a significant difference in the overall female percentages in favor of RCTs in Europe compared to LMICs but not North America or Asia and Oceania. There was no significant change in the percentage of female participants in all countries and regions over the last 2 decades, with no differences in trends between the groups. CONCLUSIONS: Sufficient female representation in clinical trials is required for the generalizability of results. Despite differences in overall percentage of female participation between countries and regions, females have been underrepresented in both HICs and LMICs with no considerable change over 2 decades.

Female Enrollment in Rehabilitation Trials: A Systematic Review of Reporting Sex and Female Participation in Randomized Controlled Trials of Poststroke Upper Extremity Rehabilitation Over 50 Years.

OBJECTIVE: To systematically assess the reporting of sex and the percentage of female participants in randomized controlled trials (RCTs) examining interventions for the post-stroke rehabilitation of upper extremity (UE) motor disorders. DATA SOURCES: CINAHL, Embase, PubMed, Scopus and Web of Science were searched from 1960 to April 1, 2021. Additional articles were identified using the Evidence-Based Review of Stroke Rehabilitation. STUDY SELECTION: Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English, (2) ≥50% of participants were diagnosed and affected by stroke, (3) included adults ≥18 years old, and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. DATA EXTRACTION: Two investigators independently screened the title and abstracts, and duplicates were removed. A full-text review was done for studies that met all inclusion criteria. Data were extracted using a custom data extraction template in Covidence and were transferred to online Excel (V16) for data management. Study characteristics and extracted variables were summarized using standard descriptive statistics. Data analyses were performed using SPSS (V29.0). DATA SYNTHESIS: A total of 1276 RCTs met inclusion criteria, and of these, 5.2% did not report results on sex, accounting for 5.6% of participants. Women have been underrepresented in stroke RCTs, accounting for 38.8% of participants. Female participation was greater in the acute poststroke phase than in the chronic and subacute phases. Over almost 5 decades, there has been a small decrease in the proportion of female participants in these trials. CONCLUSIONS: Evidence-based medicine for the treatment and prevention of stroke is guided by results from RCTs. Generalizability depends on sufficient representation in clinical trials. Stakeholders, such as funders and journal editors, play a key role in encouraging researchers to enroll enough of both sexes and to report the presence or absence of sex differences in RCTs.

The use of virtual reality for activities of daily living rehabilitation after brain injury: A scoping review.

INTRODUCTION: Individuals with acquired brain injury (ABI) experience high rates of poor functional outcomes such as inability to complete activities of daily living (ADL). Occupational therapy needs to be customised to the individual's function, goals, and environment to facilitate improvement in ADLs after ABI. Virtual reality (VR) is a novel treatment approach that aims to improve skills within an individualised environment. This study aimed to review the current literature for the use of VR platforms that incorporate ADLs to improve functional outcomes after ABI. METHODS: This review followed the six-stage framework by Arksey & O'Malley (2005). Electronic databases were searched for peer-reviewed journal articles based on inclusion and exclusion criteria. RESULTS: One thousand and six hundred eighty articles were screened, including 413 full text articles and 13 articles were included for review. Among the 13 articles, six were RCTs and the rest were pre-post intervention studies. Studies largely used non-immersive VR platforms, which incorporated ADLs such as grocery shopping, aiming to improve functional outcomes. CONSUMER AND COMMUNITY CONSULTATION: Consumer and community were not involved in executing this study. CONCLUSION: This review suggests mixed results if VR is effective at treating upper limb, cognition, and ADL function after ABI. Using their clinical reasoning, occupational therapists can determine the suitability of VR for ADL rehabilitation for specific patient populations and settings. Plain Language Summary Individuals who sustain an acquired brain injury can have difficulty performing their daily activities such as, making a meal or getting dressed, because of limited function (e.g., physical and cognitive problems). To help improve their ability to complete daily activities, occupational therapy needs to be customised to the individual's function, goals, and environment. Virtual reality is a new rehabilitation approach that allows individuals to improve their function in an individualised environment. In this study, we reviewed the current studies that have used virtual reality platforms that incorporate daily activities to improve function after acquired brain injury. We searched databases and screened the titles and abstracts of 1,680 studies. Then, 413 full-text studies were screened, and 13 studies were included. Studies mostly used non-immersive platforms to practise daily activities such as, grocery shopping, aiming to improve function after acquired brain injury. This review suggests mixed results if virtual reality can effectively treat function after acquired brain injury.

The influence of seated exercises on balance, mobility, and cardiometabolic health outcomes in individuals living with a stroke: A systematic review and meta-analysis.

OBJECTIVE: Seated exercises could prove a safe alternative to traditional weight-bearing exercises in stroke, but its effects on mobility and modifiable risk factors of stroke are limited. The objective is to investigate the effects of seated exercises on balance, mobility, and cardiometabolic health in individuals living with a stroke. DATA SOURCES: Medline, EMBASE, CINAHL, and Cochrane library were searched up to October 2022, in addition to the 2018 Evidence-Based Review of Stroke Rehabilitation. METHODS: Trials that incorporated predominantly seated exercises and outcomes of balance, mobility, or cardiometabolic health in those living with a stroke were included. Quality assessments of randomized controlled trials were done using the Cochrane Risk-of-Bias Tool. RESULTS: Seven trials were included in the review (n = 337) with five trials including participants < 6 months post-stroke. Seated exercises improved balance (standard mean difference (SMD) = 0.76; 95% confidence interval (CI), 0.50, 1.02) and mobility (SMD = 0.68; 95% CI, 0.24,1.13) outcomes compared with control. Sensitivity analysis of gait speed found no significant change (mean difference (MD) = 0.33 m/s; 95% CI, -0.23, 0.89) following seated exercises compared with control. One trial found no significant changes in blood pressure. Most trials (78%) were assessed as having some concern for bias. CONCLUSION: These findings suggest beneficial effects of seated exercises on balance and mobility outcomes in those with a stroke, compared with standard therapy or an attention control. However, there is limited evidence on the effects of seated exercises on outcomes of cardiometabolic health, particularly prominent modifiable risk factors for stroke. PROSPERO REGISTRATION NUMBER: CRD42022307426.

Responsiveness and trajectory of changes in the rating of everyday arm-use in the community and home (REACH) scale over the first-year post-stroke.

OBJECTIVE: To examine the trajectory of the Rating of Everyday Arm-use in the Community and Home (REACH) scores over the first-year post-stroke, determine if REACH scores are modified by baseline impairment level and explore the responsiveness of the REACH scale through hypothesis testing. DESIGN: Consecutive sample longitudinal study. SETTING: Participants were recruited from an acute stroke unit and followed up at three, six, and 12 months post-stroke. PARTICIPANTS: Seventy-three participants with upper limb weakness (Shoulder Abduction and Finger Extension score ≤ 8). MAIN MEASURES: The REACH scale is a six-level self-report classification scale that captures how the affected upper limb is being used in one's own environment. The Fugl-Meyer Upper Limb Assessment (FMA-UL), Stroke Upper Limb Capacity Scale (SULCS), accelerometer-based activity count ratio and Global Rating of Change Scale (GRCS) were used to capture upper limb impairment, capacity, and use. RESULTS: The following proportions of participants improved at least one REACH level: 64% from baseline to three months, 37% from three to six months and 13% from six to 12 months post-stroke. The trajectory of REACH scores over time was associated with baseline impairment. Change in REACH had a moderate correlation to change in SULCS and the GRCS but not FMA-UL or the activity count ratio. CONCLUSIONS: Results of hypothesis testing provide preliminary evidence of the responsiveness of the REACH scale. On average, individuals with severe impairment continued to show improvement in use over the first year, while those with mild/moderate impairment plateaued and a small proportion decreased in the early chronic phase.

Premotor and Posterior Parietal Cortex Activity is Increased for Slow, as well as Fast Walking Poststroke: An fNIRS Study.

Methods: Twenty individuals in the chronic stage of stroke walked: (1) at their normal pace, (2) slower than normal, and (3) as fast as possible. Functional near-infrared spectroscopy was used to assess bilateral prefrontal, premotor, sensorimotor, and posterior parietal cortices during walking. Results: No significant differences in laterality were observed between walking speeds. The ipsilesional prefrontal cortex was overall more active than the contralesional prefrontal cortex. Premotor and posterior parietal cortex activity were larger during slow and fast walking compared to normal-paced walking with no differences between slow and fast walking. Greater increases in brain activation in the ipsilesional prefrontal cortex during fast compared to normal-paced walking related to greater gait speed modulation. Conclusions: Brain activation is not linearly related to gait speed. Ipsilesional prefrontal cortex, bilateral premotor, and bilateral posterior parietal cortices are important areas for gait speed modulation and could be an area of interest for neurostimulation.

Perspectives of users for a future interactive wearable system for upper extremity rehabilitation following stroke: a qualitative study.

BACKGROUND: Wearable sensor technology can facilitate diagnostics and monitoring of people with upper extremity (UE) paresis after stroke. The purpose of this study is to investigate the perspectives of clinicians, people living with stroke, and their caregivers on an interactive wearable system that detects UE movements and provides feedback. METHODS: This qualitative study used semi-structured interviews relating to the perspectives of a future interactive wearable system including a wearable sensor to capture UE movement and a user interface to provide feedback as the means of data collection. Ten rehabilitation therapists, 9 people with stroke, and 2 caregivers participated in this study. RESULTS: Four themes were identified (1) "Everyone is different" highlighted the need for addressing individual user's rehabilitation goal and personal preference; (2) "The wearable system should identify UE and trunk movements" emphasized that in addition to arm, hand, and finger movements, detecting compensatory trunk movements during UE movements is also of interest; (3) "Both quality and amount of movements are necessary to measure" described the parameters related to how well and how much the user is using their affected UE that participants envisioned the system to monitor; (4) "Functional activities should be practiced by the users" outlined UE movements and activities that are of priority in designing the system. CONCLUSIONS: Narratives from clinicians, people with stroke, and their caregivers offer insight into the design of interactive wearable systems. Future studies examining the experience and acceptability of existing wearable systems from end-users are warranted to guide the adoption of this technology.

A Pilot Study for Remote Evaluation of Upper Extremity Motor Function After Stroke: The Arm Capacity and Movement Test (ArmCAM).

IMPORTANCE: A simple measure that can be administered remotely by means of videoconferencing is needed for telerehabilitation. OBJECTIVE: To develop a valid and reliable measure, the Arm Capacity and Movement Test (ArmCAM), that can be administered remotely by means of videoconferencing to evaluate upper extremity motor function poststroke. DESIGN: Cross-sectional. SETTING: Participants' homes. PARTICIPANTS: A sample of people with stroke (N = 31). OUTCOMES AND MEASURES: Test-retest and interrater reliabilities were assessed through intraclass correlation coefficients (ICCs), Cohen's κ, standard error of measurement (SEM), and minimal detectable change (MDC). Interrater reliability validity was examined with Pearson and Spearman rank correlation coefficients. RESULTS: The ArmCAM (range = 0-30) consists of 10 items and takes 15 min to administer with no special equipment except for a computer and internet access. The ICCs for test-retest reliability and interrater reliability were .997 and .993, respectively. The SEM and MDC95 were 0.74 and 2.05 points, respectively. Individual items' test-retest reliability and interrater levels of agreement ranged from .811 to .957 and from .475 to .842, respectively, as measured with Cohen's κ. Correlations between the ArmCAM and the Rating of Everyday Arm-use in the Community and Home scale; the Stroke Impact Scale, hand function domain; the Fugl-Meyer Assessment for upper extremity; and the Action Research Arm Test were good to excellent. CONCLUSIONS AND RELEVANCE: The ArmCAM has good reliability and validity. It is an easy-to-use assessment designed to be administered remotely by means of videoconferencing. What This Article Adds: The ArmCAM is a psychometrically sound instrument that can be easily administered remotely by means of videoconferencing to evaluate upper extremity motor function after stroke.

Group-based telerehabilitation intervention using Wii Fit to improve walking in older adults with lower limb amputation (WiiNWalk): A randomized control trial.

OBJECTIVE: Determine efficacy of the novel WiiNWalk intervention on walking-related outcomes in older adults with lower limb amputation. DESIGN: Multi-site, parallel, evaluator-masked randomized controlled trial. SETTING: Home-setting in three Canadian cities. PARTICIPANTS: Community-dwelling lower limb prosthesis users over 50 years of age. INTERVENTIONS: The WiiNWalk group (n = 38) used modified Wii Fit activities for prosthetic rehabilitation. The attention control group (n = 33) used Big Brain Academy: Wii Degree, comprising of cognitive activities. Both groups completed a 4-week supervised phase with three 1-h sessions/week in groups of three overseen by a clinician via videoconferencing and a 4-week unstructured and unsupervised phase. MAIN MEASURES: Primary outcome was walking capacity (2 min walk test); secondary outcomes were balance confidence (activities-specific balance confidence scale), dynamic balance (four-step square test), and lower limb functioning (short physical performance battery). Outcomes were compared across time points with repeated measures analysis of covariance, adjusting for baseline and age. RESULTS: Mean age was 65.0 (8.4) years, with 179.5 (223.5) months post-amputation and 80% transtibial amputation. No group difference in a 2 min walk test with an effect size: 1.53 95% CI [-3.17, 6.23] m. Activities balance confidence was greater in the WiiNWalk group by 5.53 [2.53, 8.52]%. No group difference in the four-step square test -0.16 [-1.25, 0.92] s, nor short physical performance battery 0.48 [-0.65, 1.61]. A post-hoc analysis showed the greatest difference in balance confidence immediately after an unsupervised phase. CONCLUSIONS: The WiiNWalk intervention improved balance confidence, but not walking-related physical function in older adult lower limb prosthesis users. Future rehabilitation games should be specific to the amputation context.Clinical Trial Registration number, NCT01942798.

Evaluating the impact of a training program to support transitioning from the hospital to the community for people after stroke: a community case study.

BACKGROUND: The transitions in care along the stroke recovery path are challenging, particularly in finding mechanisms to continue one's recovery once at home. We aim to evaluate the impact of training physiotherapists and fitness instructors from one regional community together to deliver an evidence-based group exercise program starting in the hospital and transitioning to the community using an implementation approach. METHODS: The evidenced based exercise program Fitness and Mobility Exercise (FAME) for stroke was chosen as the intervention. Data from interviews with stakeholders (community centre and health authority hospital staff including a physiotherapy navigator) was transcribed and themes evaluated using the RE-AIM (Reach, Efficacy, Adoption, Implementation, Maintenance) framework. These data were supplemented by information collected as a quality assurance project within the health authority. RESULTS: Two programs were established; one in the community centre (run over 15 months by fitness instructors) and one in the regional hospital (run over 12 months by a rehabilitation assistant under the direction from a physiotherapist). Transitions in care were facilitated by implementing the same evidence-based group exercise class in both the hospital and community setting, so people living with stroke could seamlessly move from one to another. An existing physiotherapist navigator service also was valued as a support for the transitions between the two centres for people with stroke. The hospital group accessed group-based physiotherapy service on average 31 days earlier than they were able to in a one-to-one format. CONCLUSIONS: This case study described the implementation of the Fitness and Mobility Exercise (FAME) program in one community and the use of a physiotherapist navigator to assist transition between them. After a community training workshop, FAME programs were established within the health authority and the community centre. FAME program participants within the health authority benefited from reduced wait times to access hospital outpatient physiotherapy service. Improvements in function were measured in and reported by the people after stroke attending either the health authority or community centre FAME groups.

Painting by lesions: White matter hyperintensities disrupt functional networks and global cognition.

White matter hyperintensities (WMH) are a prominent feature of cerebral small vessel disease and are associated with cognitive impairment. These deficits in cognition may be caused by the disruption of large-scale functional networks due to the presence of WMHs. However, knowledge regarding the relevance of these lesions on functional networks remains inconclusive. These inconsistencies may derive from issues with interpreting functional imaging data from clinical populations. Lesion network mapping is a technique that allows the overlaying of lesions from a patient population to the functional connectivity of a human connectome derived from healthy adults. This allows researchers to identify functional networks that would be disrupted in a healthy population should the WMHs seen in cerebral small vessel disease be present. We hypothesized that the extent to which these functional networks are disrupted by WMHs is associated with cognitive performance in older adults with cerebral small vessel disease. This cross-sectional study combined baseline data from four studies to create a total sample of 164 older adults (aged ≥55) from metropolitan Vancouver with cerebral small vessel disease. Using lesion network mapping, we assessed the percentage overlap between voxels functionally connected with both the WMHs (lesion network) and five common functional networks: (1) visual; (2) dorsal attention; (3) ventral attention; (4) sensorimotor; and (5) frontoparietal. Cognition was assessed using: (1) Montreal Cognitive Assessment (MoCA); (2) Stroop Colour Word Test (3-2); (3) Trail Making Tests (Part B-A); and (4) Digit Symbol Substitution Test. A One-Way ANOVA and Tukey post-hoc tests were performed to identify the functional networks with greatest percentage overlap with the lesion network. Partial correlations controlling for age were used to analyse whether the extent of the overlap between the lesion and functional networks was associated with poorer cognition. The visual, ventral attention, and frontoparietal networks had significantly greater overlap with the lesion network. After controlling for multiple comparisons, level of lesion network overlap with both the sensorimotor network (p<.001) and ventral attention network (p <. 001) was significantly correlated with MoCA score. Thus, the greater the disruption to the sensorimotor and ventral attention networks, the poorer the global cognition. Our results reveal that the visual, ventral attention, and frontoparietal networks are most vulnerable to disruptions stemming from WMHs. Additionally, we identified that disruption to the sensorimotor and ventral attention networks, as a result of WMHs, may underlie deficits in global cognition in older adults with cerebral small vessel disease.

Stroke rehabilitation in low-income and middle-income countries: a call to action.

The WHO Rehabilitation 2030 agenda recognises the importance of rehabilitation in the value chain of quality health care. Developing and delivering cost-effective, equitable-access rehabilitation services to the right people at the right time is a challenge for health services globally. These challenges are amplified in low-income and middle-income countries (LMICs), in which the unmet need for rehabilitation and recovery treatments is high. In this Series paper, we outline what is happening more broadly as part of the WHO Rehabilitation 2030 agenda, then focus on the specific challenges to development and implementation of effective stroke rehabilitation services in LMICs. We use stroke rehabilitation clinical practice guidelines from both high-income countries and LMICs to highlight opportunities for rapid uptake of evidence-based practice. Finally, we call on educators and the stroke rehabilitation clinical, research, and not-for-profit communities to work in partnership for greater effect and to accelerate progress.

Clinicians' perceptions of a potential wearable device for capturing upper limb activity post-stroke: a qualitative focus group study.

BACKGROUND: There is growing interest in the use of wearable devices that track upper limb activity after stroke to help determine and motivate the optimal dose of upper limb practice. The purpose of this study was to explore clinicians' perceptions of a prospective wearable device that captures upper limb activity to assist in the design of devices for use in rehabilitation practice. METHODS: Four focus groups with 18 clinicians (occupational and physical therapists with stroke practice experience from a hospital or private practice setting) were conducted. Data were analyzed thematically. RESULTS: Our analysis revealed three themes: (1) "Quantity and quality is ideal" emphasized how an ideal device would capture both quantity and quality of movement; (2) "Most useful outside therapy sessions" described how therapists foresaw using the device outside of therapy sessions to monitor homework adherence, provide self-monitoring of use, motivate greater use and provide biofeedback on movement quality; (3) "User-friendly please" advocated for the creation of a device that was easy to use and customizable, which reflected the client-centered nature of their treatment. CONCLUSIONS: Findings from this study suggest that clinicians support the development of wearable devices that capture upper limb activity outside of therapy for individuals with some reach to grasp ability. Devices that are easy to use and capture both quality and quantity may result in greater uptake in the clinical setting. Future studies examining acceptability of wearable devices for tracking upper limb activity from the perspective of individuals with stroke are needed.

Brain activity during real-time walking and with walking interventions after stroke: a systematic review.

Investigations of real-time brain activations during walking have become increasingly important to aid in recovery of walking after a stroke. Individual brain activation patterns can be a valuable biomarker of neuroplasticity during the rehabilitation process and can result in improved personalized medicine for rehabilitation. The purpose of this systematic review is to explore the brain activation characteristics during walking post-stroke by determining: (1) if different components of gait (i.e., initiation/acceleration, steady-state, complex) result in different brain activations, (2) whether brain activations differ from healthy individuals. Six databases were searched resulting in 22 studies. Initiation/acceleration showed bilateral activation in frontal areas; steady-state and complex walking showed broad activations with the majority exploring and finding increases in frontal regions and some studies also showing increases in parietal activation. Asymmetrical activations were often related to performance asymmetry and were more common in studies with slower gait speed. Hyperactivations and asymmetrical activations commonly decreased with walking interventions and as walking performance improved. Hyperactivations often persisted in individuals who had experienced severe strokes. Only a third of the studies included comparisons to a healthy group: individuals post-stroke employed greater brain activation compared to young adults, while comparisons to older adults were less clear and limited. Current literature suggests some indicators of walking recovery however future studies investigating more brain regions and comparisons with healthy age-matched adults are needed to further understand the effect of stroke on walking-related brain activation.

Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial.

BACKGROUND: Individuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke. METHODS: An assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months. RESULTS: Thirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported. CONCLUSIONS: This study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016).

Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation.

BACKGROUND AND PURPOSE: We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke. METHODS: This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed. RESULTS: Both DOSE1 (mean change 61 m [95% CI, 9-113], P=0.02) and DOSE2 (mean change 58 m, 6-110, P=0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care. CONCLUSIONS: This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01915368.

Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation.

BACKGROUND: The ability to walk is commonly reported as a top rehabilitation priority for individuals after a stroke. However, not all individuals with stroke are able to practice walking, especially those who require more assistance from their therapist to do so. Powered robotic exoskeletons are a new generation of robotic-assisted gait training devices, designed to assist lower extremity movement to allow repetitious overground walking practice. To date, minimal research has been conducted on the use of an exoskeleton for gait rehabilitation after stroke. The following research protocol aims to evaluate the efficacy and acceptability, and thus adoptability, of an exoskeleton-based gait rehabilitation program for individuals with stroke. METHODS: This research protocol describes a prospective, multi-center, mixed-methods study comprised of a randomized controlled trial and a nested qualitative study. Forty adults with subacute stroke will be recruited from three inpatient rehabilitation hospitals and randomized to receive either the exoskeleton-based gait rehabilitation program or usual physical therapy care. The primary outcome measure is the Functional Ambulation Category at post-intervention, and secondary outcomes include motor recovery, functional mobility, cognitive, and quality-of-life measures. Outcome data will be collected at baseline, post-intervention, and at 6 months. The qualitative component will explore the experience and acceptability of using a powered robotic exoskeleton for stroke rehabilitation from the point of view of individuals with stroke and physical therapists. Semi-structured interviews will be conducted with participants who receive the exoskeleton intervention, and with the therapists who provide the intervention. Qualitative data will be analyzed using interpretive description. DISCUSSION: This study will be the first mixed-methods study examining the adoptability of exoskeleton-based rehabilitation for individuals with stroke. It will provide valuable information regarding the efficacy of exoskeleton-based training for walking recovery and will shed light on how physical therapists and patients with stroke perceive the device. The findings will help guide the integration of robotic exoskeletons into clinical practice. TRIAL REGISTRATION: NCT02995265 (clinicaltrials.gov), Registered 16 December 2016.

Effects of Motor Skill-Based Training on Wheelchair Propulsion Biomechanics in Older Adults: A Randomized Controlled Trial.

OBJECTIVE: To identify whether motor skill-based training improves wheeling biomechanics in older adults and whether transfer or retention occurs. DESIGN: Randomized controlled trial. SETTING: Human mobility laboratory. PARTICIPANTS: Able-bodied older adults 50 years and older deemed ready to participate in physical activity (N=34). INTERVENTION: Participants were randomized to 1 of 3 groups: experimental group with 6 motor skill-based training sessions, active control group with dose-matched uninstructed practice, and the inactive control group (no training or practice). The experimental group's training sessions consisted of two 5-minute blocks of wheelchair propulsion training, separated by a 5-minute break, for a total of 60 minutes of wheeling. Breaks included education and discussion related to wheelchair propulsion. Training focused on increasing push angle, decreasing push frequency, decreasing negative braking forces, and using a circular wheeling pattern with smooth pushes. MAIN OUTCOME MEASURES: Temporal spatial and kinetic variables (ie, push angle, push frequency, total and tangential forces, negative force) were evaluated during steady-state wheeling and biomechanical variables were assessed with the SmartWheel Clinical Protocol to identify transfer. RESULTS: The training group significantly increased push angle and decreased push frequency compared with the practice (P<.05) and control groups (P<.05), which were retained over time and transferred to overground wheeling on tile (P≤.05). The dose-matched practice group did not differ from the inactive control group for any variables (P>.05). CONCLUSIONS: Older adults improve select biomechanical variables following motor skill-based training, which are retained over time and transfer to overground wheeling. Participants in the active control group did not improve with uninstructed practice compared with the inactive control group.

Evaluation and facilitation of intervention fidelity in community exercise programs through an adaptation of the TIDier framework.

BACKGROUND: Despite high quality evidence supporting multiple physical and cognitive benefits of community-based exercise for people after stroke, there is little understanding on how to facilitate uptake of these research findings to real-world programs. A common barrier is a lack of standardised training for community fitness instructors, which hampers the ability to train more instructors to deliver the program as it was designed. Scaling up program delivery, while maintaining program fidelity, is complex. The objective of this research is to explore novel use of the Template for Intervention Description and Replication (TIDier) framework to evaluate and support implementation fidelity of a community exercise program. METHODS: We embedded intervention fidelity evaluation into an inaugural training program for fitness instructors who were to deliver the Fitness and Mobility Exercise Program for stroke, which has established efficacy. The training program consisted of a face-to-face workshop followed by 3 worksite 'audit and feedback coaching cycles' provided over 3 iterations of the 12-week program offered over 1 year. A modified TIDIER checklist (with 2 additional criteria) was used within the training workshop to clarify the key 'active ingredients' that were required for program fidelity, and secondly as a basis for the audit and feedback process enabling the quantitative measurement of fidelity. Data were collected from audits of observed classes and from a survey provided by fitness instructors who implemented the program. RESULTS: We demonstrated the feasibility of the TIDier checklist to capture 14 essential items for implementation evaluation of a complex exercise intervention for people with chronic health conditions over 3 iterations of the program. Based on the audit tool, program fidelity was high and improved over time. Three content areas for workplace coaching (intensity monitoring, space, and educational tips) were identified from the audit tool and were addressed. CONCLUSION: Training of staff to deliver exercises to high need populations utilising workshops and workplace coaching that used the TIDier framework for training, onsite audit and feedback resulted in a high level of fidelity to the program principles. A novel checklist based on the TIDier framework was useful for embedding implementation fidelity in complex community-based interventions.

Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke.

BACKGROUND: Wearable activity monitors that track step count can increase the wearer's physical activity and motivation but are infrequently designed for the slower gait speed and compensatory patterns after stroke. New and available technology may allow for the design of stroke-specific wearable monitoring devices, capable of detecting more than just step counts, which may enhance how rehabilitation is delivered. The objective of this study was to identify important considerations in the development of stroke-specific lower extremity wearable monitoring technology for rehabilitation, from the perspective of physical therapists and individuals with stroke. METHODS: A qualitative research design with focus groups was used to collect data. Five focus groups were conducted, audio recorded, and transcribed verbatim. Data were analyzed using content analysis to generate overarching categories representing the stakeholder considerations for the development of stroke-specific wearable monitor technology for the lower extremity. RESULTS: A total of 17 physical therapists took part in four focus group discussions and three individuals with stroke participated in the fifth focus group. Our analysis identified four main categories for consideration: 1) 'Variability' described the heterogeneity of patient presentation, therapy approaches, and therapeutic goals that are taken into account for stroke rehabilitation; 2) 'Context of use' described the different settings and purposes for which stakeholders could foresee employing stroke-specific wearable technology; 3) 'Crucial design features' identified the measures, functions, and device characteristics that should be considered for incorporation into prospective technology to enhance uptake; and 4) 'Barriers to adopting technology' highlighted challenges, including personal attitudes and design flaws, that may limit the integration of current and future wearable monitoring technology into clinical practice. CONCLUSIONS: The findings from this qualitative study suggest that the development of stroke-specific lower extremity wearable monitoring technology is viewed positively by physical therapists and individuals with stroke. While a single, specific device or function may not accommodate all the variable needs of therapists and their clients, it was agreed that wearable monitoring technology could enhance how physical therapists assess and treat their clients. Future wearable devices should be developed in consideration of the highlighted design features and potential barriers for uptake.