The Efficacy and Safety of Early Rehabilitation in Large Vessel Occlusion Patients After Intra-arterial Thrombectomy: A Prospective Randomized Controlled Trial

Study Overview
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Brief Summary
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Early rehabilitation is feasible for stroke patients is still under debate. In addition, IA thrombectomy has been a new treatment for the past few years and currently no known research exploring the efficacy of very early rehabilitation after thrombectomy, or any possible rehabilitation-related adverse effects. Therefore, in this study, the investigators will investigate the effectiveness of earlier rehabilitation intervention after IA thrombectomy for cerebral large vessel occlusion based on functional independence.

Detailed Description
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The study will be the prospective randomized controlled trial, where patients eligible for inclusion will be randomly assigned to earlier rehabilitation group or control group. The investigators will analyze the correlation between frequency/intensity of rehabilitation and primary/secondary outcomes. Dose-response analysis for earlier rehabilitation will be performed.

Official Title
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Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan

Conditions
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Intra-arterial Thrombectomy

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cerebral stroke due to infarction of large vessels in the anterior circulation, including internal carotid artery (, middle cerebral artery (MCA) M1 or M2 segment, anterior cerebral artery (ACA) A1 segment Receive arterial thrombectomy (IA thrombectomy) Stable vital signs include heartbeat less than 130 bpm, systolic blood pressure less than 180mmHg, blood oxygen SpO2 >92% No use of pressors, oxygen masks or respirators after arterial thrombectomy Exclusion Criteria: Posterior circulation large vessel stroke Functional score (mRS) ≥ 3 points before the stroke Other contraindications for rehabilitation treatment Neurosurgery immediately after this stroke Those who cannot receive rehabilitation within one week of stroke due to serious medical problems After the stroke, two specialists judged the end of life and arranged palliative and palliative treatment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental)<br>The effectiveness of early rehabilitation interventions within 24 hours compared with the control group | Other: exercise<br>* exercise group: first bed exercise after 0 24hr onset ; sit at bed after 24 48hr onset control group: first bed exercise after 24 48hr onset ; sit at bed after 48 72hr onset<br>|
| Active Comparator: effectiveness of earlier rehabilitation intervention after IA thrombectomy(control)<br>The effectiveness of early rehabilitation interventions compared with the experimental group | Other: exercise<br>* exercise group: first bed exercise after 0 24hr onset ; sit at bed after 24 48hr onset control group: first bed exercise after 24 48hr onset ; sit at bed after 48 72hr onset<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) | Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means more disability) | 3rd months after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | sum score:0 100(higher score means more functional independence ) | 1st and 3rd months after stroke | 
| Modified Rankin Scale (mRS) | Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means | 1st months after stroke | 
| Fugl-Meyer Assessment | U/E total score:66 L/E total score:34 the higher score means better movement performance | 1st and 3rd month after stroke |