Barriers to Enrollment in a Post-Stroke Neuromodulation and Walking Study: Implications for Recruiting Women

Background Women have a higher risk of stroke and related disability than men but are underrepresented in stroke clinical trials. Identifying modifiable recruitment and enrollment barriers for women can improve study generalizability, statistical power, and resource utilization. Objective In a post-stroke neuromodulation study, we determined the impact of sex on the occurrence of exclusion criteria and compared the sex distribution of screened and enrolled individuals with a broader stroke-affected population. Methods A total of 335 individuals with chronic stroke were screened for a study examining how neuromodulation and high-intensity treadmill training affect walking speed and corticomotor excitability. Demographics and exclusions were retrospectively gathered as a secondary dataset. Exclusion criteria consisted of 6 categories (not target population, unable to do treadmill protocol, unable to do non-invasive brain stimulation, insufficient ankle motion and disinterest, and cognitive impairment). Incidence of each exclusion criterion was compared between women and men. The sex distribution was compared to a dataset from Chicago primary stroke centers. Results A total of 81 individuals were enrolled and 254 were not. The percentage of women excluded was significantly greater than that of men (P = .04). No individual exclusion criterion or categories excluded women more frequently than men. Screened and enrolled individuals had a lower proportion of women and younger age than a representative stroke population (P