Abstract

Introduction: Inclusion of diverse stroke patient populations is key for generalizable and clinically meaningful stroke rehabilitation clinical trials. The aim of this study was to assess 1) the reporting and inclusion of race, ethnicity, and gender in publications on motor recovery clinical trials post-stroke, and 2) the quality of the clinical trial. Methods: All stroke motor recovery clinical trials published in ten leading rehabilitation journals in the United States between 2012 and 2021 with at least one control group were identified. The percent of different racial minorities, ethnicities, and women enrolled in the trials was extracted and calculated for those trials with available data found in the manuscript or on clinicaltrials.gov. The quality of the trial was determined by the PEDro score. Results: 57 trials (total of 3004 participants) met the inclusion criteria and were included in the analysis. 97%, 37%, and 23% of the trials included reported enrollment by gender, race, and ethnicity, in the manuscript or on clinicaltrials.gov. Among trials reporting race, 59% of participants were White, followed by 30% Black, 1% Native American, 4% Asian and 10% Other. Among the trials that reported ethnicity, Hispanic or Latino participants were represented as 10% of the total participants. The average PEDro score was 7. Conclusions: While most stroke rehab trial publications were of good quality and reported data on sex, they did not report race/ethnicity, though this information was collected on clinicaltrials.gov. Improvement in the inclusion and reporting of race/ethnicity in stroke motor recovery trials is needed to allow for better generalizability in the future.

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