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

Sponsor

National Taiwan University Hospital Hsin-Chu Branch (Other)

Overall Status

Recruiting

CT.gov ID

NCT05764278

Collaborator

(none)

Enrollment

Location

Arms

11.6

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intra-arterial Thrombectomy	Other: exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Barthel Index [1st and 3rd months after stroke]
sum score:0~100(higher score means more functional independence )
Modified Rankin Scale (mRS) [1st months after stroke]
Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan	Hsinchu		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital Hsin-Chu Branch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital Hsin-Chu Branch

ClinicalTrials.gov Identifier:

NCT05764278

Other Study ID Numbers:

111-048-F

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 10, 2023