Feasibility of Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Pilot Randomized Trial

Objective To evaluate the feasibility and preliminary effects of a behavioral intervention with guided stepping training early post-stroke (BIG STEPS). Design Pilot waitlist-controlled randomized trial. Setting Community Participants Twenty-eight individuals with ischemic or hemorrhagic stroke (13 female [46%]; mean age: 67.8 ±13.3 years). Interventions A 12-week BIG STEPS intervention to reduce sedentary time and increase daily steps was delivered to the early BIG STEPS group (n = 14) and after a 12-week waitlist period to the delayed BIG STEPS group (n = 14). Both groups received usual care. Main measures Feasibility, adherence, and safety. Exploratory outcomes included accelerometer-derived movement behaviors, timed walking tests, and patient-reported outcomes. Results Recruitment averaged 2.3 participants per month. Retention exceeded a priori threshold of 80% at weeks 12 and 24 (86-93%). No intervention-related serious adverse events occurred. At week 12, the early BIG STEPS group accumulated a mean of 6534 ± 2773 steps/day compared with 4031 ± 2072 steps/day in the delayed BIG STEPS group. Sedentary time decreased by approximately 1.4 hours/day in the early group and 0.7 hours/day in the delayed group. Between-group effects favoured the early group for daily steps (Hedges’ g = 1.4) and reduced sedentary time (Hedges’ g = −1.1). At week 24, outcomes converged after the delayed BIG STEPS group received the intervention. Between-group differences for timed walking tests and patient-reported outcomes were small. Conclusion A behavioral intervention combined with guided stepping training early after stroke was feasible and safe, with promising preliminary effects.