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.

A systematic review examining the effect of vitamin D supplementation on functional outcomes post-stroke.

OBJECTIVE: The objective of this systematic review was to explore the effect of vitamin D supplementation on functional outcomes (motor function, mobility, activities of daily living and stroke impairment) among individuals post-stroke (PROSPERO CRD42022296462). DATA SOURCES: MEDLINE, PsycINFO, EMBASE, and CINAHL were searched for all articles published up to March 5, 2023. METHODS: Only interventional studies assessing vitamin D supplementation compared to placebo or usual care in adult stroke patients were selected. After duplicate removal, 2912 studies were screened by two independent reviewers. A total of 43 studies underwent full text review; 10 studies met inclusion criteria (8 randomized controlled trials and 2 non-randomized studies of intervention). Data were extracted by two independent reviewers using Covidence software. Motor function (Brunnstrom Recovery Stage, Berg Balance Score), mobility (Functional Ambulation Category), activities of daily living (Barthel Index, Functional Independence Measure) and stroke impairment (modified Rankin Scale, National Institutes for Health Stroke Severity, Scandinavian Stroke Severity) were the outcome measures of interest reported in the included studies. RESULTS: In total, 691 patients were studied for which 11 of 13 outcome measures showed improvement with vitamin D supplementation. CONCLUSIONS: The majority of studies showed a statistical improvement in motor function, mobility, and stroke impairment with vitamin D supplementation; however, the evidence did not support an improvement in activities of daily living with treatment. Despite this, there may not be clinical significance. Strong, methodologically sound, randomized controlled trials are required to verify these findings.

Network Meta-Analysis of Non-Conventional Therapies for Improving Upper Limb Motor Impairment Poststroke.

BACKGROUND: Network meta-analysis is a method that can estimate relative efficacy between treatments that may not have been compared directly within the literature. The purpose of this study is to present a network meta-analysis of non-conventional interventions to improve upper extremity motor impairment after stroke. METHODS: A literature search was conducted in 5 databases from their inception until April 1, 2021. Terms were used to narrow down articles related to stroke, the upper extremity, and interventional therapies. Randomized controlled trials written in English were eligible if; 50% poststroke patients; ≥18 years old; applied an intervention for the upper extremity, and/or used the Fugl-Meyer upper extremity scale as an outcome measure; the intervention had ≥3 randomized controlled trials with comparisons against a conventional care group; conventional care groups were dose matched for therapy time. A Bayesian network meta-analysis approach was taken to estimate mean difference (MD) and 95% CI. RESULTS: One hundred seventy-six randomized controlled trials containing 6781 participants examining 20 non-conventional interventions were identified for inclusion within the final model. Eight of the identified interventions proved significantly better than conventional care, with modified constraint induced movement therapy (MD, 6.7 [95% CI, 4.3-8.9]), high frequency repetitive transcranial magnetic stimulation (MD, 5.4 [95% CI, 1.9-8.9]), mental imagery (MD, 5.4 [95% CI, 1.8-8.9]), bilateral arm training (MD, 5.2 [95% CI, 2.2-8.1]), and intermittent theta-burst stimulation (MD, 5.1 [95% CI, 0.62-9.5]) occupying the top 5 spots according to the surface under the cumulative ranking curve. CONCLUSIONS: Overall, it would seem that modified constraint induced movement therapy has the greatest probability of being the most effective intervention, with high-frequency repetitive transcranial magnetic stimulation, mental imagery, and bilateral arm training all having similar probabilities of occupying the next spot in the rankings. We think this analysis can provide a guide for where future resources and clinical trials should be directed, and where a clinician may begin when considering alternative therapeutic interventions.

Predictors of Spasticity 3-6 Months Post Stroke: A 5-Year Retrospective Cohort Study.

OBJECTIVE: To identify predictors of post stroke spasticity (PSS; modified Ashworth Scale scores, mAS ≥1) at 3-6 months post stroke. DESIGN: A 5-year (2015-2020) retrospective cohort of patients who attended inpatient stroke rehabilitation in Southwestern Ontario, Canada were included. Sociodemographic, clinical, stroke-related, rehabilitation-related, and outcome measure data were extracted from paper charts and electronic databases. RESULTS: Of the 922 individuals attending inpatient stroke rehabilitation, 606 (55.8% males; mean age = 70.9 ± 14.2 years) returned for an outpatient visit. Most patients had a first ever (n = 518; 85.5%), ischemic (n = 470; 77.6%) stroke with hemiplegia (n = 449, 74.1%). A total of 20.3% (N = 122) of patients had developed PSS by 4 months post stroke. A binary logistic regression significantly predicted PSS (χ2(6) = 111.696, p < .0001) with good model fit (χ2(8) = 12.181, p = .143). There were six significant PSS predictors: hemorrhagic stroke (p = .049), younger age (p < .001), family history of stroke (p = .015), Functional Independence Measure admission score (p < .001), use of SSRIs p = .044), and hemiplegia (p < .001). CONCLUSIONS: Patients should be monitored closely for PSS after discharge from stroke rehabilitation and throughout the care continuum.

A systematic review of randomized controlled trial characteristics for interventions to improve upper extremity motor recovery post stroke.

INTRODUCTION: Given the prevalence of motor deficits post-stroke, a large proportion of stroke rehabilitation interventions are directed toward motor recovery. OBJECTIVES: The purpose of this study is to present a detailed investigation of the methodological characteristics in the stroke rehabilitation literature with respect to randomized controlled trials (RCTs) designed to facilitate upper extremity motor recovery. METHODS: This review was conducted following guidelines from the Preferred Reporting Items for Systematic reviews and Meta Analyses (PRISMA) statement. English articles of RCTs were eligible if they were published before April 1, 2021 and applied an intervention to the hemiparetic upper extremity of individuals post stroke as the primary objective of the study, or recorded at least one upper extremity related outcome measure. RESULTS: The number of RCTs for upper extremity rehabilitation interventions post stroke has been increasing, with over three quarters of RCTs published in the last decade. In total, 1,307 RCTs met inclusion criteria for which the mean sample size (start/finish) was 45.8 (SD 55.4)/41.8 (SD 49.7). The median sample size (start/finish) was 30 (IQR 20-48)/29 (IQR 19-44). The mean PEDro score was 6.12 (SD 1.55). 251 RCTs (19%) were multi-centered trials. Key methodological measures of quality remain low including the blinding of assessors (59%), intention to treat analyses (42%) and concealed allocation (37%). CONCLUSIONS: There is a large number of RCTs evaluating stroke rehabilitation upper extremity interventions. Research quality continues to be a challenge (low percentage of key quality indicators, small percentage of multicentred trials, small sample sizes) but is slowly improving.

Developing a framework for utilizing adjunct rehabilitation therapies in motor recovery of upper extremity post stroke.

INTRODUCTION: Standardization of first principles has transformed stroke rehabilitation in developed countries and helped guide the appropriate allocation of resources to ensure better outcomes for patients. There have been challenges in incorporating new evidence into stroke rehabilitation practices. The sheer number of RCTs can be daunting to the average clinician, made worse by the lack of a framework for their application. OBJECTIVES: To develop a framework for the introduction of adjunct practices for the motor recovery of the upper extremity post stroke into clinical practice. METHODOLOGY: A literature search following PRISMA guidelines revealed 1,307 RCTs involving rehabilitation interventions for the hemiparetic upper extremity post stroke. RESULTS: Therapies were divided into three categories of therapies: (1) Basic Conventional Therapy Approaches (<15% of interventions), (2) Adjunct Therapies Designed to Enhance Conventional Therapies (>85% of interventions), and (3) Treatment to Manage Complications (~9% of interventions). Adjunct Therapies, despite having a spectacular evidence base, are often not employed clinically. To encourage their clinical use, we have developed a framework that divides adjunct therapies into two categories: (1) Treatments that Stimulate the Brain (i.e. rTMS, mental practice, and virtual reality) and (2) Treatments that Peripherally Facilitate the Hemiparetic Upper Extremity (i.e. robotics, EMG Biofeedback, and Constraint-induced Movement Therapy). CONCLUSION: To allow stroke rehabilitation to continue to improve upper extremity recovery and outcomes, we propose a new intuitive framework that is based on a strong evidence base to guide clinicians and improve stroke rehabilitation.

A national survey of evidence-based stroke rehabilitation intervention use in clinical practice among Canadian occupational therapists.

BACKGROUND: More than 1,000 randomized controlled trials have been published examining the effectiveness of stroke rehabilitation interventions. OBJECTIVE: The objective of this study was to explore the use and non-use of evidence-based stroke rehabilitation interventions in clinical practice among Occupational Therapists across various stroke rehabilitation settings in Canada. METHODS: Participants were recruited from medical centres providing rehabilitation to stroke patients in each of the ten provinces across Canada (January-July 2021). Adult (18 + years) Occupational Therapists who provide direct rehabilitative care to individuals after a stroke completed a survey in either English or French. Therapists rated their awareness, use, and reasons for non-use of stroke rehabilitation interventions. RESULTS: 127 therapists (female = 89.8%), largely from Ontario or Quebec (62.2%) were included; most worked full-time (80.3%) in moderate-large (86.1%) cities. The greatest use of interventions were those applied to the body peripherally, without a technological component. Few individuals were aware of interventions applied to the brain (priming or stimulating) with a technological component, and they were rarely, if ever, used. CONCLUSION: Significant efforts should be made to increase the awareness of interventions which are supported by strong evidence through knowledge translation and implementation initiatives, particularly for those with a technological component.

Differences in stroke rehabilitation motor and cognitive randomized controlled trials by world region: Number, sample size, and methodological quality.

BACKGROUND: Stroke rehabilitation research is important for informing clinical practice and directing health care resources. OBJECTIVE: To examine how motor- and cognitive-based stroke rehabilitation randomized controlled trials (RCTs) vary by world region, overall and over time, with respect to 1) publication volume, 2) sample size, and 3) methodological quality. METHODS: Using the Evidence-Based Review of Stroke Rehabilitation (EBRSR), all motor- and cognitive-based stroke rehabilitation RCTs were identified. The following data were extracted: first author, year of publication, country of origin, and sample size. Countries were categorized into seven regions, as defined by the World Bank. RESULTS: In total 1410 motor-based RCTs and 293 cognitive-based RCTs were published between 1972-2018. For motor RCTs, the East Asia/Pacific region accounted for the largest volume of RCTs (n = 530; 37.6%), followed closely by the Europe/Central Asia region (n = 445; 31.6%). Conversely, the largest producer for cognitive RCTs was Europe/Central Asia (n = 167; 57.0%), followed by East Asia/Pacific (n = 62; 21.2%). For both motor and cognitive RCTs, there was no significant difference between world regions with respect to mean sample size or methodological quality. CONCLUSIONS: Efforts should be directed towards improving methodological quality and increasing sample sizes of stroke rehabilitation-related studies.