Systematic Review of Worldwide Female Enrollment in Randomized Controlled Trials of Poststroke Lower Extremity Rehabilitation

ABSTRACT: This review systematically examined the reporting of sex and female participation in poststroke lower extremity motor rehabilitation randomized controlled trials over time and identified differences in female participation across randomized controlled trials conducted in low- and middle-income countries, high-income countries, and high-income country regions. Systematic searches were conducted of MEDLINE, Embase, CINAHL, and PsycINFO from 1970 to May 2022. Randomized controlled trials in English were included if they examined poststroke LE motor rehabilitation interventions in adults diagnosed with stroke. A total of 1283 randomized controlled trials were analyzed; 4.5% of randomized controlled trials did not report sex, and the overall female participation was 39.5%. The percentage of female participants did not significantly differ between high-income countries and low- and middle-income countries. Within high-income countries, the percentage of female participants was significantly higher in European randomized controlled trials than randomized controlled trials in Asia and Oceania ( P = 0.01). 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 randomized controlled trials 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 underenrollment and further efforts are required to ensure adequate enrollment of males and females.