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

NCT ID: NCT05764278

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2023-12-31

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.

Conditions

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Intra-arterial Thrombectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental)

The effectiveness of early rehabilitation interventions within 24 hours compared with the control group

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

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

effectiveness of earlier rehabilitation intervention after IA thrombectomy(control)

The effectiveness of early rehabilitation interventions compared with the experimental group

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsing-Yu Chen

Role: CONTACT

035326151 ext. 523504

Meng Ting Lin, MD

Role: CONTACT

0223123456 ext. 67651

Facility Contacts

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Hsing-Yu Chen

Role: primary

035326151 ext. 523504

Other Identifiers

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111-048-F

Identifier Type: -

Identifier Source: org_study_id

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