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Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient

Status Approved

First Submitted Date

2018/08/08
Registered Date

2018/09/23
Last Updated Date

2018/09/21

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003215
Unique Protocol ID	2016-07-148
Public/Brief Title	Intensive Motor Rehabilitation in Stroke Patient
Scientific Title	Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	Yes
Name of Registry / Registration Number	ClinicalTrials.gov-NCT03168386
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC 2016-07-148-001
Approval Date	2016-10-18
Institutional Review Board Name	Samsung Medical Center IRB
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Yun-Hee Kim
Title	Prof
Telephone	+82-2-3410-2818
Affiliation	Samsung Medical Center
Address	81 Irwon-ro Gangnam-gu, Seoul
Contact Person for Public Queries
Name	Won Hyuk Chang
Title	Associate Prof.
Telephone	+82-2-3410-6068
Affiliation	Samsung Medical Center
Address	81 Irwon-ro Gangnam-gu, Seoul
Contact Person for Updating Information
Name	Won Hyuk Chang
Title	Associate Prof.
Telephone	+82-2-3410-6068
Affiliation	Samsung Medical Center
Address	81 Irwon-ro Gangnam-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 8
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-11-17 Actual
Target Number of Participant	196
Primary Completion Date	2018-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2016-11-18 ,
Recruitment Status by Participating Study Site 2
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-11-20 ,
Recruitment Status by Participating Study Site 3
Name of Study	Konkuk University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2016-12-06 ,
Recruitment Status by Participating Study Site 4
Name of Study	Chungnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-12-11 ,
Recruitment Status by Participating Study Site 5
Name of Study	Pusan National University Yangsan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-11-17 ,
Recruitment Status by Participating Study Site 6
Name of Study	Kyungpook National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-11-21 ,
Recruitment Status by Participating Study Site 7
Name of Study	Wonkwang University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-01-23 ,
Recruitment Status by Participating Study Site 8
Name of Study	Jeju National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-11-28 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Centers for Disease Control and Prevention
Organization Type	Government
Project ID	2016E-33003

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The objective of this study is to investigate the effect of the intensive motor rehabiliiation during subacute stroke phase on motor recovery at 6 months after onset in the first-ever stroke patients.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Non-RCT
Intervention Type	Others (physical rehabilitation therapy)
Intervention Description	Intensive motor rehabilitation therapy
Number of Arms	1
Arm 1	Arm Label Intensive Motor Rehabilitation group
	Target Number of Participant 196
	Arm Type Experimental
	Arm Description Intensive motor rehabilitation from 2 weeks (±1 week) after stroke onset - conventional physical & occupational therapy (150~180 min) with additional motor rehabilitation therapy (60 min) - 5 session/week * 4 weeks (total 40 sessions)

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I64)Stroke, not specified as haemorrhage or infarction
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description ① Stroke onset less than 7 days ② more than 19 years old ③ stroke confirmed by CT or MRI ④ Fugl-Meyer upper limb score at 7 days after stroke: 25~40점 ⑤ No definite contracture of affected upper limb ⑥ agreement with intensive motor rehabilitation for 4 weeks
Exclusion Criteria	Transient ischemic attacks
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Change of Fugl-Meyer upper limb score
Timepoint	6 months after stroke onset
Secondary Outcome(s) 1
Outcome	Change of Korean Mini Mental State Examination
Timepoint	6 months after stroke onset

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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