A phase III, multi-arm multi-stage covariate-adjusted response-adaptive randomized trial to determine optimal early mobility training after stroke (AVERT DOSE)

Abstract

Rationale: The evidence base for acute post-stroke rehabilitation is inadequate and global guideline recommendations vary. Aim: To define optimal early mobility intervention regimens for ischemic stroke patients of mild and moderate severity. Hypotheses: Compared with a prespecified reference arm, the optimal dose regimen(s) will result in more participants experiencing little or no disability (mRS 0–2) at 3 months post-stroke (primary), fewer deaths at 3 months, fewer and less severe complications during the intervention period, faster recovery of unassisted walking, and better quality of life at 3 months (secondary). We also hypothesize that these regimens will be more cost-effective. Samp..