Back to resultsEffect of Intensive Motor Rehabilitation in Subacute Stroke Patient
Primary Purpose
Stroke, Rehabilitation, Motor Function
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intensive motor rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intensive motor rehabilitation group
Arm Description
Outcomes
Primary Outcome Measures
Upper limb score of Fugl-Meyer assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03168386
Brief Title
Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
Official Title
Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
Intensive cognitive rehabilitation group
- physical and occupational therapy for 3 hours on every working day for 2 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Motor Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intenstive motor rehabilitation
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive motor rehabilitation group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intensive motor rehabilitation
Intervention Description
Intensive motor rehabilitation during subacute stroke phase
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25886039
Citation
Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5.
Results Reference
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Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
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