Time Window for Ischemic Stroke First Mobilization Effectiveness: Protocol for an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial

Author:

Zheng Yu1,Yan Chengjie2,Shi Haibin3,Niu Qi4,Liu Qianghui5,Lu Shanshan6,Zhang Xintong1,Cheng Yihui1,Teng Meiling1,Wang Lu1,Zhang Xiu1,Hu Xiaorong1,Li Jian1,Lu Xiao1,Reinhardt Jan D78910,

Affiliation:

1. Department of Rehabilitation Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

2. Department of Neurorehabilitation, Kunshan Rehabilitation Hospital, Kunshan, China

3. Department of Interventional Radiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

4. Department of Geriatric Neurology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

5. Department of Emergency, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

6. Department of Nuclear Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

7. Institute for Disaster Management and Reconstruction of Sichuan University, Chengdu, China

8. Hong Kong Polytechnic University, Chengdu, China

9. Swiss Paraplegic Research, Nottwil, Switzerland

10. Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland

Abstract

Abstract Objective The purpose of this study is to investigate the optimal time window for initiating mobilizing after acute ischemic stroke. Methods 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 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. Impact The TIME Trial is designed to answer the question “when is the best time to start mobilization after stroke?” 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.

Funder

Nanjing Municipal Science and Technology Bureau

Stroke Prevention and Treatment Project of the National Health Commission

First Affiliated Hospital of Nanjing Medical University

Publisher

Oxford University Press (OUP)

Subject

Physical Therapy, Sports Therapy and Rehabilitation

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