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A study on healthy people for validity verification of rehabilitation exercise and augmented reality based motion biomarker analysis system.

Status Approved

First Submitted Date

2019/10/30
Registered Date

2019/11/15
Last Updated Date

2020/01/17

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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	KCT0004440
Unique Protocol ID	DUIH 2019-09-009-001
Public/Brief Title	Validity and reliability verification of motion biomarker analysis system (Smart bar).
Scientific Title	A study on healthy people for validity verification of rehabilitation exercise and augmented reality based motion biomarker analysis system.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
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	DUIH 2019-09-009-001
Approval Date	2019-10-25
Institutional Review Board Name	Dongguk University Ilsan Hospital IRB
Institutional Review Board Address	27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
Institutional Review Board Telephone	031-961-8405
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	BUMSUN KWON
Title	professor
Telephone	+82-31-961-7480
Affiliation	Dongguk University Ilsan Hospital
Address	814 Siksa-dong Ilsandong-gu Goyang-si Gyeonggi-do
Contact Person for Public Queries
Name	JIHYUN KIM
Title	Researcher
Telephone	+82-31-961-8445
Affiliation	Dongguk University Ilsan Hospital
Address	814 Siksa-dong Ilsandong-gu Goyang-si Gyeonggi-do
Contact Person for Updating Information
Name	JIHYUN KIM
Title	Researcher
Telephone	+82-31-961-8445
Affiliation	Dongguk University Ilsan Hospital
Address	814 Siksa-dong Ilsandong-gu Goyang-si Gyeonggi-do

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	2019-11-28 Actual
Target Number of Participant	10
Primary Completion Date
Study Completion Date	2019-11-28 , Actual
Name of Study	Dongguk University Ilsan Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-11-28 ,

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	Ministry of Science and ICT
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Dongguk University Ilsan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Incorrect posture habits can lead to deformity of the spine and pain, which leads to difficulties in healthy daily life. The smart device is a rehabilitation assistance system that allows the general public to easily and comfortably perform professional rehabilitation exercises performed in the hospital. The smart device is designed to acquire the exercise posture signal during stretching and to maintain the correct posture. The purpose of this study is to verify the reliability of joint angles measured during stretching of the neck of the turtle (Forward head posture) and scoliosis using healthy bar.

Study Summary Information

Lay Summary

Incorrect posture habits can lead to deformity of the spine and pain, which leads to difficulties in healthy daily life.
The smart device is a rehabilitation assistance system that allows the general public to easily and comfortably perform professional rehabilitation exercises performed in the hospital. 
The smart device is designed to acquire the exercise posture signal during stretching and to maintain the correct posture.
The purpose of this study is to verify the reliability of joint angles measured during stretching of the neck of the turtle (Forward head posture) and scoliosis using healthy bar.

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	10
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label A healthy person doing turtle neck and scoliosis stretching using a smart bar.
Cohort/ Group 1	Cohort/Group Description 1 day total visit. It takes about 30 minutes. Measurement of joint angle during stretching for turtle neck and scoliosis using smart bar and Goniometer.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Residents of Goyang City who are 19 years old or older who can visit Dongguk Daeilsan Oriental Buddhism Hospital
Sampling Method	Convenience extracted on a first come, first served basis.
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M43.62)Torticollis, cervical region Healthy person
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description Healthy men and women 19 years of age or older who agree with the study.
Exclusion Criteria	A person with limitations with other joint problems. A person with a cognitive or behavioral disorder that is difficult to perform this study. do not agree with the study.
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	Efficacy
Outcome	The difference between the joint angles measured by the smart bar and the joint goniometer at the end of the stretching motion.
Timepoint	Joint angle measurement after turtle neck and scoliosis stretching.
Secondary Outcome(s) 1
Outcome	The difference between the joint angles measured by the smart bar and the joint goniometer at the beginning of the stretching motion.
Timepoint	Measure before turtle neck and scoliosis stretching posture.

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	Not provided at time of Registration

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