Statistical analysis plan (SAP) for A Very Early Rehabilitation Trial (AVERT): An international trial to determine the efficacy and safety of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset vs. usual stroke unit care

Abstract

Currently, the acute stroke interventions for which there is evidence of efficacy are stroke unit care (a complex package), selected surgery , aspirin and thrombolysis. The stroke unit effect is powerful with a 20% relative reduction in mortality and similar reduction in disability. However the key components of this ‘black box’ are unknown. Starting out of bed sitting, standing and walking training early after stroke (early mobilization) have emerged as a component of care that may make an important contribution to the stroke unit care effect.