AVERT DOSE
(2026)Objective
Phase III adaptive multi-arm RCT to determine the optimal dose of early mobilization after mild and moderate ischemic stroke for 90-day functional outcome.
Study Summary
• Primary 90-day mRS 0-2: no significant difference between session-intensity arms in either NIHSS stratum.
• Mild stroke (NIHSS <7): no evidence of benefit with higher mobilization doses vs 1 session of 10 min.
• Moderate stroke (NIHSS 8-16): 2 sessions of 10 min were clinically meaningfully better than 1 session (frequentist sensitivity).
• Sample size/design modified due to funding constraints.
• Mild stroke (NIHSS <7): no evidence of benefit with higher mobilization doses vs 1 session of 10 min.
• Moderate stroke (NIHSS 8-16): 2 sessions of 10 min were clinically meaningfully better than 1 session (frequentist sensitivity).
• Sample size/design modified due to funding constraints.
Intervention
Three arms of varying mobility intensity vs standard care (usual mobility)
Inclusion Criteria
International, N=1000 (planned, adjusted). Within 48 h after stroke onset; stratified by severity: mild (NIHSS <7) n=650 and moderate (NIHSS 8-16) n=350.
Study Design
Arms: Three doses of early mobilization vs standard care
Patients per Arm: Mild stratum n=650; Moderate stratum n=350 (target N=1000)
Outcome
• Primary 90-day mRS 0-2: no significant difference between session intensities in either stratum.
• Mild stroke: no evidence higher mobilization doses superior to 1 session 10 min.
• Moderate stroke: 2 sessions x 10 min clinically meaningful vs 1 session (sensitivity).
• Design modified mid-trial due to funding constraints.
• Mild stroke: no evidence higher mobilization doses superior to 1 session 10 min.
• Moderate stroke: 2 sessions x 10 min clinically meaningful vs 1 session (sensitivity).
• Design modified mid-trial due to funding constraints.