Time window for ischemic stroke first mobilization effectiveness: Protocol for an investigator-initiated prospective multicenter randomized 3-arm clinical trial

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• Early Mobilization (10 posts to May 2014)

 

 Time window for ischemic stroke first mobilization effectiveness: Protocol for an investigator-initiated prospective multicenter randomized 3-arm clinical trial

Physical Therapy , Volume 101(5)

NARIC Accession Number: J86625.  What's this?
ISSN: 0031-9023.
Author(s): Zheng, Yu ; Yan, Chengjie ; Shi, Haibin ; Niu, Qi ; Liu, Qianghui ; Lu, Shanshan ; Zhang, Xintong; Cheng, Yihui ; Teng, Meiling ; Wang, Lu ; Zhang, Xiu ; Hu, Xiaorong ; Li, Jian ; Lu, Xiao ; Reinhardt, Jan D..
Publication Year: 2021.
Number of Pages: 11.

Abstract: 

 Article presents the protocol for a study investigating the optimal time window for initiating mobilizing after acute ischemic stroke. 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 and will enroll 6,033 eligible patients with acute ischemic stroke. Participants will be randomly allocated to either (1) the very early mobilization group in which mobilization 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. The effect of timing is isolated from the effect of type and dose of mobilization by otherwise applying a standard mobilization protocol across groups. The TIME Trial may, therefore, contribute to increasing the knowledge base regarding the optimal time window for initiating mobilization after acute ischemic stroke.
Descriptor Terms: BODY MOVEMENT, EARLY INTERVENTION, INTERNATIONAL REHABILITATION, PHYSICAL THERAPY, REHABILITATION RESEARCH, RESEARCH METHODOLOGY, STROKE.


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Citation: Zheng, Yu , Yan, Chengjie , Shi, Haibin , Niu, Qi , Liu, Qianghui , Lu, Shanshan , Zhang, Xintong, Cheng, Yihui , Teng, Meiling , Wang, Lu , Zhang, Xiu , Hu, Xiaorong , Li, Jian , Lu, Xiao , Reinhardt, Jan D.. (2021). Time window for ischemic stroke first mobilization effectiveness: Protocol for an investigator-initiated prospective multicenter randomized 3-arm clinical trial.  Physical Therapy , 101(5) Retrieved 8/26/2021, from REHABDATA database.