CClinicalTrials.gg
RecruitingNCT05764278Updated May 19, 2023

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

An interventional study of exercise in Intra-arterial Thrombectomy, sponsored by National Taiwan University Hospital Hsin-Chu Branch. Recruiting at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by National Taiwan University Hospital Hsin-Chu Branch · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intra-arterial Thrombectomy
03

In context

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch is the lead sponsor of 35 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Active comparator
    effectiveness of earlier rehabilitation intervention after IA thrombectomy(control)

    The effectiveness of early rehabilitation interventions compared with the experimental group

    Other: exercise

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

06

What researchers measure

Primary outcomes

  1. Modified Rankin Scale (mRS)

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

    Time frame: 3rd months after stroke

Secondary outcomes

  1. Barthel Index

    sum score:0\~100(higher score means more functional independence )

    Time frame: 1st and 3rd months after stroke

  2. Modified Rankin Scale (mRS)

    Modified Rankin Scale (mRS) at 3rd months after stroke:6 grades(higher grades means

    Time frame: 1st months after stroke

  3. Fugl-Meyer Assessment

    U/E total score:66 L/E total score:34 the higher score means better movement performance

    Time frame: 1st and 3rd month after stroke

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan
    Hsinchu, Taiwan
    • Hsing-Yu Chen · Contact · 035326151
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05764278
Lead sponsor
National Taiwan University Hospital Hsin-Chu Branch
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Jan 11, 2023
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 19, 2023

Study contacts

Hsing-Yu Chen
Contact
G54088@hch.gov.tw
035326151 ext. 523504
Meng Ting Lin, MD
Contact
b96401093@ntu.edu.tw
0223123456 ext. 67651

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion