NCT05764278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

December 21, 2022

Last Update Submit

May 17, 2023

Conditions

Intra-arterial Thrombectomy

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS)

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

    3rd months after stroke

Secondary Outcomes (3)

  • Barthel Index

    1st and 3rd months after stroke

  • Modified Rankin Scale (mRS)

    1st months after stroke

  • Fugl-Meyer Assessment

    1st and 3rd month after stroke

Study Arms (2)

effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental)

EXPERIMENTAL

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

Other: exercise

effectiveness of earlier rehabilitation intervention after IA thrombectomy(control)

ACTIVE COMPARATOR

The effectiveness of early rehabilitation interventions compared with the experimental group

Other: exercise

Interventions

exerciseOTHER

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)effectiveness of earlier rehabilitation intervention after IA thrombectomy(experimental)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch Hsinchu, Taiwan

Hsinchu, Taiwan

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hsing-Yu Chen

CONTACT

035326151G54088@hch.gov.tw

Meng Ting Lin, MD

CONTACT

0223123456b96401093@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

March 10, 2023

Study Start

January 11, 2023

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)