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The Effect of Backward Walking Observation Training On Balance and Walking Ability In Chronic Stroke Patients

Status Approved

First Submitted Date

2018/07/12
Registered Date

2018/08/17
Last Updated Date

2018/08/06

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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	KCT0003098
Unique Protocol ID	1044396-201803-HR-083-01
Public/Brief Title	the effect of balance and walking ability of stroke patients who have seen a backward walking video
Scientific Title	The Effect of Backward Walking Observation Training On Balance and Walking Ability In Chronic Stroke Patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	1044396-201803-HR-083-01
Approval Date	2018-03-27
Institutional Review Board Name	Gachon University Institutional Review Board
Institutional Review Board Address	1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-750-8566
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	YEONGSOOK BAE
Title	professor
Telephone	+82-32-820-4324
Affiliation	Gachon University
Address	1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	YIYEOP MOON
Title	student
Telephone	+82-2-3281-5910
Affiliation	Gachon University
Address	1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	YIYEOP MOON
Title	student
Telephone	+82-2-3281-5910
Affiliation	Gachon University
Address	1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of 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	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2018-04-02 Actual
Target Number of Participant	14
Primary Completion Date
Study Completion Date
Name of Study	Mokdong Hyundai Hospital
Recruitment Status	Completed
Date of First Enrollment	2018-04-02 ,

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	Gachon University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Gachon University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Most patients with post-stroke hemiparesis increasingly recover their walking ability; however, it may be difficult to achieve sufficient locomotion ability to perform a variety of activities required for their daily routine without any disruptions. Limitation of walking ability for stroke patients leads to many functional limitations of life. Action observation training is a training method that brings about improvements in actual skills through the activation of the brain region obtained by observing, imitating, and practicing others’ actions. Action observation training groups that observed actual actions and repeatedly practiced the same physical actions as they had observed actions showed significantly larger training effects than groups that repeated simple actions without observing actions. Although walking observation training and backward walking training have been studied extensively, the study of backward walking observation training is extremely difficult to find. The backward walking observation training investigate affect of dynamic balance, walking ablilty to stroke patients Investigate the difference between backward walking observation training group and landscape group

Study Summary Information

Lay Summary

Most patients with post-stroke hemiparesis increasingly recover their walking ability; however, it may be difficult to achieve sufficient locomotion ability to perform a variety of activities required for their daily routine without any disruptions.
Limitation of walking ability for stroke patients leads to many functional limitations of life.
Action observation training is a training method that brings about improvements in actual skills through the activation of the brain region obtained by observing, imitating, and practicing others’ actions.
Action observation training groups that observed actual actions and repeatedly practiced the same physical actions as they had observed actions showed significantly larger training effects than groups that repeated simple actions without observing actions.
Although walking observation training and backward walking training have been studied extensively, the study of backward walking observation training is extremely difficult to find.
The backward walking observation training investigate affect of  dynamic balance, walking ablilty  to stroke patients
Investigate the difference between backward walking observation training group and landscape group

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	Factorial
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others (action observation training)
Intervention Description	During the backward walking observation training session, subjects were encouraged to concentrate on the video clips, to imitate the backward walking tasks in same way as portrayed in the video clips,with the supervision of a physiotherapist. Control group performed the walking tasks, which is same with the walking tasks that subjects of the experimental group practiced.
Number of Arms	2
Arm 1	Arm Label backward walking observation group
	Target Number of Participant 7
	Arm Type Experimental
	Arm Description 30 minutes at once, three times a week, for a 4-weeks period 4 functional Backward walking video observaiton 10m + Backward walking training 20m
Arm 2	Arm Label Landscape observaiton group
	Target Number of Participant 7
	Arm Type Sham comparator
	Arm Description 30 minutes at once, three times a week, for a 4-weeks period Landscape video observation 10m + Backward walking training 20m

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 No Limit~No Limit
	Description >=12 months after stroke onset >=10m independent gait absence of cognitive alterations (>=24 points on mini-mental state examination). absence of orthopedic impairment of trunk and lower limbs absence of visual and auditory deficits
Exclusion Criteria	cerebellar or brainstem damage those who are taking medication due to psychological anxiety
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	Not applicable
Outcome	10Meter Walking Test:10MWT
Timepoint	intervetion before & after
Secondary Outcome(s) 1
Outcome	Dynamic Gait Index:DGI
Timepoint	intervetion before & after
Secondary Outcome(s) 2
Outcome	Timed Up&GO:TUG
Timepoint	intervetion before & after

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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