- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03168386
Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
March 6, 2024 updated by: Yun-Hee Kim, Samsung Medical Center
Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications.
However, there was no consensus of proper amount of motor rehabilitation in stroke patients.
In this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Intensive cognitive rehabilitation group
- physical and occupational therapy for 3 hours on every working day for 2 weeks
Study Type
Interventional
Enrollment (Actual)
196
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Acute first-ever stroke
- Upper limb score of Fugl-Meyer assessment at 7 days after onset : 25~84
Exclusion Criteria:
- Transient ischemic stroke
- Joint contracture of affected upper extremity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensive motor rehabilitation group
|
Intensive motor rehabilitation during subacute stroke phase
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Upper limb score of Fugl-Meyer assessment
Time Frame: Change of upper limb score of Fugl-Meyer assessment after intensive motor rehabilitation for 4 weeks
|
Change of upper limb score of Fugl-Meyer assessment after intensive motor rehabilitation for 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yun-Hee Kim, MD,PhD, Samsung Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
May 22, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-07-148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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