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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| Nanjing Tongren Hospital | OTHER |
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Early mobilization was thought to be effective in patients with acute ischemic stroke. As the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. However, it is uncertain that which and when medical service focusing on functional recovery should be delivered after the emergency interventions for stroke. Besides, the optimal time window, for delivering early mobilization after acute ischemic stroke, has not been verified with strong evidence.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| very early rehabilitation | Experimental | early mobilization initiates within 24h from the onset of the disease |
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| relative early rehabilitation | Experimental | early mobilization initiates between 24-72h from the onset of the disease |
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| late mobilization group | Experimental | early mobilization initiates after 72h from the onset of the disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale | modified Rankin Scale, to evaluate a subject's disability status. It's a rating data. The degrees range from 0 to 6, higher values represent a worse outcome and severe disability. | 3 months after the cerebrovascular accident/or the last time appeared normally |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index | ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability. | the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally |
| modified Rankin Scale |
| Measure | Description | Time Frame |
|---|---|---|
| CBF | cerebral blood flow | the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally |
| CBV | cerebral blood volume |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Xiao, MD/PHD | Contact | +86 025-83718836 | 3029 | luxiao1972@163.com |
| Yan Chengjie, postgraduate | Contact | +8615995610375 | jiabailie00@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Xiao, MD/PHD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33513232 | Derived | 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. |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
Patients with acute ischemic stroke fulfilling the inclusion and exclusion criteria will be randomly allocated to either 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.
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Pre-admission trial assistants and medical staff aware of group allocation will not have contact with the patients. At each study site, a group of physiotherapists will be responsible for the interventions for all three study groups. Multi-disciplinary physicians, assessors, data analysts, and statisticians will be blinded to the group allocation.
|
modified Rankin Scale, to evaluate a subject's disability status. It's a rating data. The degrees range from 0 to 6, higher values represent a worse outcome and severe disability. |
| the total score of mRS will be recorded 15days、1month、6months after the cerebrovascular accident/or the last time appeared normally |
| MMSE | Mini-mental State Examination. To evaluate a subject's mental state.The total score range from 0 to 30, higher values represent a better outcome. | the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally |
| NIHSS scores | National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome. | the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally |
| Incidence of important medical events | falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc. | The incidence of important medical events will be recorded 15days、1month、3 months after the cerebrovascular accident/or the last time appeared normally |
| Hospital LOS | length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay | Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally |
| Total medical cost | addition of the cost of each admission of the acute hospital and the rehabilitation hospital | medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally |
| the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally |
| FA | fractional anisotropy, a outcome of diffusion tensor imaging | 3months after the cerebrovascular accident/or the last time appeared normally |
| MD | mean diffusivity,a outcome of diffusion tensor imaging | 3months after the cerebrovascular accident/or the last time appeared normally |
| rsFC | resting-state functional connectivity | the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |