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Clinical Efficacy and Safety of muscle strengthening and balancing rehabilitation exercise for elders

Status Approved

First Submitted Date

2017/09/07
Registered Date

2017/11/17
Last Updated Date

2017/10/27

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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	KCT0002544
Unique Protocol ID	CUH-2017-02-031
Public/Brief Title	Rehabilitation exercise of muscle strength and balance for elders
Scientific Title	Clinical Efficacy and Safety of muscle strengthening and balancing rehabilitation exercise for elders
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CUH-2017-02-031-001
Approval Date	2017-04-27
Institutional Review Board Name	Chonbuk National University Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

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	Myoung-Hwan Ko
Title	Professor
Telephone	+82-63-250-1795
Affiliation	Jeonbuk National University Hospital
Address	Geonjiro 20, Deokjin-gu, Jeonju-si, Jeollabuk-do, 54907, Korea
Contact Person for Public Queries
Name	Kap-Soo Han
Title	Research Professor
Telephone	+82-63-259-3462
Affiliation	Jeonbuk National University Hospital
Address	Geonjiro 20, Deokjin-gu, Jeonju-si, Jeollabuk-do, 54907, Korea
Contact Person for Updating Information
Name	Kap-Soo Han
Title	Research Professor
Telephone	+82-63-259-3462
Affiliation	Jeonbuk National University Hospital
Address	Geonjiro 20, Deokjin-gu, Jeonju-si, Jeollabuk-do, 54907, Korea

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 : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2017-07-26 Actual
Target Number of Participant	40
Primary Completion Date	2018-07-25 , Anticipated
Study Completion Date	2018-07-25 , Anticipated
Name of Study	Jeonbuk National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-07-26 ,
Recruitment Status by Participating Study Site 2
Name of Study	Pusan National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-09-11 ,

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	Ministry of Health & Welfare
Organization Type	Government
Project ID	HI15C1529

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Jeonbuk National University Hospital
Organization Type	Medical Institute
2. Sponsor Organization
Organization Name	Pusan National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The aim of the study was to evaluate the clinical efficacy and safety of newly developed rehabilitaion exercise device based on the daily activities in stroke rehabilitation.Patients were randomized in two groups: one intervent group (20 patients) and a control group (20 patients). The first and second group received three times of balancing training of upper and lower extremity or conventional treatment per week, respectively and received totally 24 times of training.

Study Summary Information

Lay Summary

The aim of the study was to evaluate the clinical efficacy and safety of newly developed rehabilitaion exercise device based on the daily activities in stroke rehabilitation.Patients were randomized in two groups: one intervent group (20 patients) and a control group (20 patients). The first and second group received three times of balancing training of upper and lower extremity or conventional treatment per week, respectively and received totally 24 times of training.

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	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Each group receives three times of rehabilitation training or conventional training per week, respectively and receives totally 24 times of training within 8 weeks
Number of Arms	2
Arm 1	Arm Label Medical device exercise group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Three times of rehabilitation training using medical device per week, and totally 24 times of treatments within 8 weeks.
Arm 2	Arm Label Conventional training group
	Target Number of Participant 20
	Arm Type Active comparator
	Arm Description Three times of conventional rehabilitation training per week, and totally 24 times of treatments within 8 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R54)Senility
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 65Year~85Year
	Description 1) Age of 65 to 85 years 2) Ability to understand and follow simple explanations and commands
Exclusion Criteria	1) Medical conditions which may affect physical performance or the physical activity may become unsafe 2) Other severe conditions not able to participate in the treatments 3) Low cognitive or psychiatric conditions 4) Loss of Upper and lower extremities 5) Currently participating other clinical trial test
Healthy Volunteers	Yes

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	/Safety/Efficacy
Outcome	Five times sit to stand test
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)
Primary Outcome(s) 2
Outcome	KFES-I(Korean version of fall efficacy scale-international)
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)
Secondary Outcome(s) 1
Outcome	Berg balance test
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)
Secondary Outcome(s) 2
Outcome	Timed Up and Go test
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)
Secondary Outcome(s) 3
Outcome	10m walking time
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)
Secondary Outcome(s) 4
Outcome	Chair sit and reach test
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)
Secondary Outcome(s) 5
Outcome	Lower extremity MMT (Manual muscle test)
Timepoint	Pre-evaluation, Post-treatment(after completion of 18 treatment sessions), Post-treatment (at 4weeks)

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

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	Not provided at time of Registration

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