A very early rehabilitation trial for stroke (AVERT) phase II safety and feasibility

Background and Purpose - Very early rehabilitation, with an emphasis on mobilization, may contribute to improved outcomes after stroke. We hypothesized that a very early rehabilitation protocol would be safe and feasible. Methods - We performed a randomized, controlled trial with blinded outcome assessment. Patients at < 24 hours after stroke were recruited from 2 Melbourne metropolitan stroke units. Patients were randomly assigned to receive standard care (SC) or SC plus very early mobilization (VEM) until discharge or 14 days ( whichever was sooner). The primary safety outcome was the number of deaths at 3 months. The primary feasibility outcome was a higher "dose" of mobilization achieved in VEM. Secondary safety outcomes included adverse events ( including falls and early neurologic deterioration), compliance with physiologic monitoring criteria, and patient fatigue after interventions. Secondary feasibility outcomes included "contamination" of standard care. Results - Overall, 18% of patients screened were suitable for recruitment. Seventy-one patients were recruited and randomized, with 2 dropouts by 12 months. The majority experienced ischemic strokes (87%). The group mean +/- SD age was 74.7 +/- 12.5 years, and 58% (n=41) had a National Institutes of Health Stroke Scale score > 7. There was no significant difference in the number of deaths between groups (SC, 3 of 33; VEM, 8 of 38; P=0.20). Almost all deaths occurred in patients with severe stroke. Secondary safety outcomes were similar between groups. The intervention protocol was successfully delivered, achieving VEM dose targets (double SC, P=0.003) and faster time to first mobilization (P < 0.001). Conclusions - VEM of patients within 24 hours of acute stroke appears safe and feasible. Intervention efficacy and cost-effectiveness are currently being tested in a large randomized, controlled trial.