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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intra-arterial Thrombectomy
• Intervention / Treatment: Other: exercise

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsing-Yu Chen; Phone Number: 523504 035326151; Email: G54088@hch.gov.tw
• Study Contact Backup: Name: Meng Ting Lin, MD; Phone Number: 67651 0223123456; Email: b96401093@ntu.edu.tw

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • Recruiting
    • National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan
    • Contact: Hsing-Yu Chen; Phone Number: 523504 035326151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental); The effectiveness of early rehabilitation interventions within 24 hours compared with the control group	Other: exercise; 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
Active Comparator: effectiveness of earlier rehabilitation intervention after IA thrombectomy(control); The effectiveness of early rehabilitation interventions compared with the experimental group	Other: exercise; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 111-048-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No