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

Not Applicable

Recruiting

• Conditions: Intra-arterial Thrombectomy
• Interventions: Other: exercise

• Registration Number: NCT05764278
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-21
• Study Start: 2023-01-11
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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
2. Receive arterial thrombectomy (IA thrombectomy)
3. Stable vital signs include heartbeat less than 130 bpm, systolic blood pressure less than 180mmHg, blood oxygen SpO2 >92%
4. No use of pressors, oxygen masks or respirators after arterial thrombectomy

Exclusion Criteria

1. Posterior circulation large vessel stroke
2. Functional score (mRS) ≥ 3 points before the stroke
3. Other contraindications for rehabilitation treatment
4. Neurosurgery immediately after this stroke
5. Those who cannot receive rehabilitation within one week of stroke due to serious medical problems
6. After the stroke, two specialists judged the end of life and arranged palliative and palliative treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental)	exercise	The effectiveness of early rehabilitation interventions within 24 hours compared with the control group
effectiveness of earlier rehabilitation intervention after IA thrombectomy(control)	exercise	The effectiveness of early rehabilitation interventions compared with the experimental group

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	3rd months after stroke	Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means more disability)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan; 🇨🇳 Hsinchu, Taiwan