Minorities are under-reported and females are under-represented in stroke motor recovery trials

Background: Inclusion of diverse patient populations in stroke rehabilitation clinical trials is key for generalizability and detecting differences in subgroups. The aim of this study was to assess the reporting and inclusion of race, ethnicity, and sex in publications in post-stroke motor recovery clinical trials over the past 5 years.

Methods: We conducted a systematic review of stroke motor recovery trials conducted only within the United States with at least one control group and published between 2019 and 2023. The percent of racial minorities, ethnicities, and women enrolled in the trials was extracted and calculated for those trials using available data found in the manuscript or on clinicaltrials.gov.

Results: Sixty-eight trials (total of 2,801 participants) met the inclusion criteria and were included in the analysis. 100%, 35%, and 21% of the trials included reported enrollment by sex, race, and ethnicity in the manuscript. All publications reported sex and 38% of the subjects were female. Among the trials reporting race, 59% of the participants were White, followed by 34% Black, 0.4% Native American, 4% Asian, and 3% Other. Among the trials that reported ethnicity, Hispanic or Latino participants were represented as 13% of the total participants.

Conclusions: In the past 5 years, while all stroke rehab trial publications reported data on sex, they underrepresented women. Most publications did not report race or ethnicity. Improvement in reporting of race/ethnicity in stroke motor recovery trials is needed for understanding of progress with inclusion, and improvement in inclusion of women is needed for better generalizability.