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

N

National Taiwan University Hospital Hsin-Chu Branch

Status

Enrolling

Conditions

Intra-arterial Thrombectomy

Treatments

Other: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05764278
111-048-F

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hsing-Yu Chen; Meng Ting Lin, MD

Data sourced from clinicaltrials.gov

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