Time Window for Ischemic Stroke First Mobilization Effectiveness (TIME)

China Stroke Databank Center

Status: Unknown

Conditions: Brain Ischemia; Stroke Rehabilitation

Treatments: Other: early rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03938311

GN-2018R0010

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

very early rehabilitation

Experimental group

Description:

early mobilization initiates within 24h from the onset of the disease

Treatment:

Other: early rehabilitation

relative early rehabilitation

Experimental group

Description:

early mobilization initiates between 24-72h from the onset of the disease

Treatment:

Other: early rehabilitation

late mobilization group

Experimental group

Description:

early mobilization initiates after 72h from the onset of the disease

Treatment:

Other: early rehabilitation