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A study for the standardization of Ba Duanjin motion

Status Approved

First Submitted Date

2019/04/19
Registered Date

2019/04/24
Last Updated Date

2020/02/29

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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	KCT0003840
Unique Protocol ID	BD-sdz-01
Public/Brief Title	A study for the standardization of Ba Duanjin (similar to taichi) motion
Scientific Title	A study for the standardization of Ba Duanjin motion
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 exempt
Board Approval Number	WKIRB 2019-3
Approval Date	2019-03-29
Institutional Review Board Name	WKUGH(WonKwang University Gwangju Hospital) IRB
Institutional Review Board Address	1140-23, Hoejae-ro, Nam-gu, Gwangju
Institutional Review Board Telephone	062-670-6825
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	sangkwan Les
Title	Professor
Telephone	+82-62-670-6407
Affiliation	Wonkwang University
Address	1140-23, Hoejae-ro, Nam-gu, Gwangju, Republic of Korea
Contact Person for Public Queries
Name	Geonhui Gang
Title	Researcher
Telephone	+82-62-670-6711
Affiliation	Wonkwang University, Gwangju Medical Center
Address	1140-23, Hoejae-ro, Nam-gu, Gwangju, Republic of Korea
Contact Person for Updating Information
Name	Geonhui Gang
Title	Researcher
Telephone	+82-62-670-6711
Affiliation	Wonkwang University, Gwangju Medical Center
Address	1140-23, Hoejae-ro, Nam-gu, Gwangju, 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	Not yet recruiting
Date of First Enrollment	2019-05-01 Anticipated
Target Number of Participant	20
Primary Completion Date	2019-07-10 , Anticipated
Study Completion Date	2019-09-30 , Anticipated
Name of Study	Wonkwang University, Gwangju Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-05-01 ,

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	Wonkwang University, Gwangju Medical Center
Organization Type	Medical Institute
Project ID	BD-sdz-01

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Wonkwang University, Gwangju Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	PURPOSE: To determine the angles of joints, the angular velocity of each segment, the force applied to the joints, and the degree of activity of the muscles in each movement of the arm, and to provide clear instructions for such movement. In addition, EEG, respiration, and biological signals, such as to determine whether the Baduanjin is causing an orienting resposne as a method of emotion. Background: The exact protocol of Baduanjin movements is not standardized because of the problems that are not addressed and quantified. Therefore, it is necessary to provide clear guidelines for Baduanjin motion by standardizing the operations of these drawings. In addition, Korean medicine is a kind of urinal toilet therapy is using the doctrine of emotion. It is related to the orienting response, but the concrete basis is insufficient. Therefore, it is necessary to confirm this. Hypothesis: The angular velocity of each segment, the force applied, and the muscle activity will change during each movement, and will also cause a stereotyped response.

Study Summary Information

Lay Summary

PURPOSE: To determine the angles of joints, the angular velocity of each segment, the force applied to the joints, and the degree of activity of the muscles in each movement of the arm, and to provide clear instructions for such movement. In addition, EEG, respiration, and biological signals, such as to determine whether the Baduanjin is causing an orienting resposne as a method of emotion.
Background: The exact protocol of Baduanjin movements is not standardized because of the problems that are not addressed and quantified. Therefore, it is necessary to provide clear guidelines for Baduanjin motion by standardizing the operations of these drawings. In addition, Korean medicine is a kind of urinal toilet therapy is using the doctrine of emotion. It is related to the orienting response, but the concrete basis is insufficient. Therefore, it is necessary to confirm this.
Hypothesis: The angular velocity of each segment, the force applied, and the muscle activity will change during each movement, and will also cause a stereotyped response.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Prospective
Target Number of Participant	20
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Experimental group
Cohort/ Group 1	Cohort/Group Description When performing Ba Duanjin motion, observe the joint angle, the angular velocity of each body segment, the force applied to the joint, and the degree of muscle activity. In addition, EEG, respiration, and vital signs were examined to observe whether Ba Duanjin motion evokes an orienting resposne as an emotion qigong.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Those residing in Gwangju Metropolitan City who use this medical institution.
Sampling Method	convenience sampling
Condition(s)/Problem(s)	Not Applicable-Etc Therapeutics [E02] Physical Therapy Modalities [E02.779] Exercise Movement Techniques [E02.779.474] Tai Ji [E02.779.474.913] Therapeutics [E02] Complementary Therapies [E02.190] Mind-Body Therapies [E02.190.525] Tai Ji [E02.190.525.890]
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~49Year
	Description ∙ Those who are between the ages of 20 and 50 ∙ Those who voluntarily sign a consent to the clinical study. However, the person who can not agree on the free will is the person who has agreed with the legal representative ∙ Those who are willing to cooperate during the study period and who will comply with the restrictions
Exclusion Criteria	∙ People with mental illness who are difficult to communicate ∙ Those who have difficulty communicating because they have no conscious intensive care ∙ Patients who are pregnant ∙ Those who are judged to have conditions that could affect the evaluation of this study by the judgment of the researcher other than the above conditions
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	Not applicable
Outcome	Joint angle
Timepoint	Visit 1, Visit 2
Primary Outcome(s) 2
Outcome	Center of Gravity
Timepoint	Visit 1, Visit 2
Primary Outcome(s) 3
Outcome	EMG (Electromyogram)
Timepoint	Visit 1, Visit 2
Primary Outcome(s) 4
Outcome	EEG (electroencephalogram)
Timepoint	Visit 1, Visit 2
Primary Outcome(s) 5
Outcome	HRV (Heart Rate Variability)
Timepoint	Visit 1, Visit 2
Primary Outcome(s) 6
Outcome	EDA (ElectroDermal Activity)
Timepoint	Visit 1, Visit 2
Secondary Outcome(s) 1
Outcome	Pupil dilation
Timepoint	Visit 1, Visit 2

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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