Time Window for Ischemic Stroke First Mobilization Effectiveness
NCT ID: NCT03938311
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1500 participants
INTERVENTIONAL
2019-08-13
2022-12-31
Brief Summary
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Detailed Description
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Study design: an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial
Sample size: 1500 cases
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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very early rehabilitation
early mobilization initiates within 24h from the onset of the disease
early rehabilitation
The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible.
Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.
relative early rehabilitation
early mobilization initiates between 24-72h from the onset of the disease
early rehabilitation
The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible.
Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.
late mobilization group
early mobilization initiates after 72h from the onset of the disease
early rehabilitation
The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible.
Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.
Interventions
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early rehabilitation
The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible.
Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.
Eligibility Criteria
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Inclusion Criteria
* 2 aged 18 years or older;
* 3 of ischemic stroke within 12 hours before eligibility check;
* 4 able to verbally respond to the instructions;
* 5 with stable vital signs (systolic blood pressure 120-180 mmHg, heart rate 50-100/min, body temperature \<37.5◦C, blood oxygen saturation \>92%)
* 6MMSE score \> 16;
* 7participation in the TIME Trial and sign the consent form.
Exclusion Criteria
* 2 NIHSS score \< 2;
* 3 pre-morbid modified Ranking Scale (mRS) score of 3-5;
* 4 refusing randomization;
* 5 having severe limb dysfunction or systemic diseases rendering them unable to cooperate in the mobilization intervention;
* 6 having severe cognitive and mental dysfunctions;
* 7 currently enrolled in another trial or having participated in a clinical trial within 6 months before stroke onset.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Nanjing Tongren Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Nanjing Jiangbei People's Hospital
OTHER
The First People's Hospital of Lianyungang
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Zibo Central Hospital
OTHER_GOV
Liaocheng People's Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Xingtai People's Hospital
OTHER
The First Hospital of Hebei Medical University
OTHER
Cangzhou Central Hospital
OTHER
Anhui Provincial Hospital
OTHER_GOV
The First Affiliated Hospital of Bengbu Medical University
OTHER
Jingmen No.1 People's Hospital
OTHER
Wuhan University
OTHER
Hainan General Hospital
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
Shanghai Pudong Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Chongqing Three Gorges Central Hospital
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
First People's Hospital of Yulin
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
China Stroke Databank Center
OTHER
Responsible Party
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Xiao Lu,MD
Chief Physician
Principal Investigators
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Lu Xiao, MD/PHD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Zhang Xintong, Xintong
Role: backup
References
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Zheng Y, Yan C, Shi H, Niu Q, Liu Q, Lu S, Zhang X, Cheng Y, Teng M, Wang L, Zhang X, Hu X, Li J, Lu X, Reinhardt JD; TIME Trial Collaboration Group. Time Window for Ischemic Stroke First Mobilization Effectiveness: Protocol for an Investigator-Initiated Prospective Multicenter Randomized 3-Arm Clinical Trial. Phys Ther. 2021 May 4;101(5):pzab038. doi: 10.1093/ptj/pzab038.
Other Identifiers
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GN-2018R0010
Identifier Type: -
Identifier Source: org_study_id
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