A Systematic Review of Worldwide Female Enrollment in Randomized Controlled Trials of Post-Stroke Lower Extremity Rehabilitation

This review systematically examined the reporting of sex and female participation in post-stroke lower extremity (LE) motor rehabilitation randomized controlled trials (RCTs) over time and identified differences in female participation across RCTs conducted in low-and-middle-income countries (LMICs), high-income-countries (HICs), and HIC-regions. Systematic searches were conducted of MEDLINE, Embase, CINAHL and PsycINFO from 1970 to May 2022. RCTs in English were included if they examined post-stroke LE motor rehabilitation interventions in adults diagnosed with stroke. A total of 1,285 RCTs were analyzed; 4.5% of RCTs did not report sex, and the overall female participation was 39.4%. The percentage of female participants did not significantly differ between HICs and LMICs. Within HICs, the percentage of female participants was significantly higher in European RCTs than RCTs in Asia & Oceania (P = 0.008). No significant changes in female participation were found for any of the countries or regions over the last two decades. Female participation was significantly higher in RCTs conducted in the acute phase compared to those in the chronic phase (p < 0.001). More research is needed to understand the reasons behind female under-enrollment and further efforts are required to ensure adequate enrollment of males and females.