Time Window for Ischemic Stroke First Mobilization Effectiveness
- Conditions
- Brain IschemiaStroke Rehabilitation
- Interventions
- Other: early rehabilitation
- Registration Number
- NCT03938311
- Lead Sponsor
- China Stroke Databank Center
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- 1 diagnosed with ischemic stroke through anamnesis, clinical symptoms, and radiographic assessment;
- 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.
- 1 diagnosed with hemorrhagic stroke;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description late mobilization group early rehabilitation early mobilization initiates after 72h from the onset of the disease relative early rehabilitation early rehabilitation early mobilization initiates between 24-72h from the onset of the disease very early rehabilitation early rehabilitation early mobilization initiates within 24h from the onset of the disease
- Primary Outcome Measures
Name Time Method modified Rankin Scale 3 months after the cerebrovascular accident/or the last time appeared normally 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.
- Secondary Outcome Measures
Name Time Method Barthel Index the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.
modified Rankin Scale the total score of mRS will be recorded 15days、1month、6months after the cerebrovascular accident/or the last time appeared normally 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.
MMSE the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally 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.
NIHSS scores the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally National Institute of Health stroke scale，total scores range from 0 to 42, higher values represent a better outcome.
Incidence of important medical events The incidence of important medical events will be recorded 15days、1month、3 months after the cerebrovascular accident/or the last time appeared normally falls, trauma, fracture, syncope, epilepsy, pneumonia, atelectasis, venous thrombosis, pulmonary embolism, pressure sores, death, etc.
Hospital LOS Hospital LOS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally length of stay in the acute hospital and in the rehabilitation hospital, and total hospital length of stay
Total medical cost medical cost will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally addition of the cost of each admission of the acute hospital and the rehabilitation hospital
Trial Locations
- Locations (1)
the First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
🇨🇳Nanjing, Jiangsu, China