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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05764278
Enrollment
40
Registered
2023-03-10
Start date
2023-01-11
Completion date
2023-12-31
Last updated
2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-arterial Thrombectomy

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.

Interventions

OTHERexercise

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

Sponsors

National Taiwan University Hospital Hsin-Chu Branch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale (mRS)3rd months after strokeModified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means more disability)

Secondary

MeasureTime frameDescription
Barthel Index1st and 3rd months after strokesum score:0\ 100(higher score means more functional independence )
Modified Rankin Scale (mRS)1st months after strokeModified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means
Fugl-Meyer Assessment1st and 3rd month after strokeU/E total score:66 L/E total score:34 the higher score means better movement performance

Countries

Taiwan

Contacts

Primary ContactHsing-Yu Chen
G54088@hch.gov.tw035326151
Backup ContactMeng Ting Lin, MD
b96401093@ntu.edu.tw0223123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026