Time Window for Ischemic Stroke First Mobilization Effectiveness

The TIME Trial is a pragmatic, investigator‐initiated, multi‐center, randomized, 3‐arm parallel group, clinical trial. This trial will be conducted in 57 general hospitals in mainland China affiliated with the China Stroke Databank Center and will enroll 6033 eligible patients with acute ischemic stroke. Participants will be randomly allocated to either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke. The mobilization protocol is otherwise standardized and identical for each comparison group. Mobilization is titrated by baseline mobility level and progress of patients throughout the intervention period. The primary outcome is death or disability assessed with the modified Rankin scale at 3 months poststroke. Secondary outcomes include impairment score of the National Institutes of Health Stroke Scale, dependence in activities of daily living as measured using the modified Barthel Index, cognitive ability assessed with the Mini‐Mental State Examination, incidence of adverse events, hospital length of stay, and total medical costs. Study design: an Investigator‐Initiated Prospective Multicenter Randomized 3‐Arm Clinical Trial Sample size: 1500 cases