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Relationship Between Closed Kinetic Chain Upper Extremity Stability test (CKCUES test) and serratus anterior, external rotator, triceps brachii and trunk flexion sterngth.

Status Approved

First Submitted Date

2021/01/23
Registered Date

2021/04/05
Last Updated Date

2021/01/23

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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	KCT0006058
Unique Protocol ID	1041849-202002-BM-019-02
Public/Brief Title	Relationship Between Closed Kinetic Chain Upper Extremity Stability test (CKCUES test) and serratus anterior, external rotator, triceps brachii and trunk flexion sterngth.
Scientific Title	Relationship Between Closed Kinetic Chain Upper Extremity Stability test (CKCUES test) and serratus anterior, external rotator, triceps brachii and trunk flexion sterngth.
Acronym	Closed Kinetic Chain Upper Extremity Stability test -> CKCUES test, Serratus Anterior -> SA,
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	1041849-202002-BM-019-02
Approval Date	2020-09-12
Institutional Review Board Name	Yonsei University Wonju Institutional Review Board
Institutional Review Board Address	1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do
Institutional Review Board Telephone	033-760-5238
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	kwon oh yun
Title	professor
Telephone	+82-33-760-2721
Affiliation	Yonsei University
Address	1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea
Contact Person for Public Queries
Name	weon young soo
Title	BPT
Telephone	+82-33-764-3451
Affiliation	Yonsei University
Address	1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea
Contact Person for Updating Information
Name	weon young soo
Title	BPT
Telephone	+82-33-764-3451
Affiliation	Yonsei University
Address	1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-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	Recruiting
Date of First Enrollment	2021-02-08 Anticipated
Target Number of Participant	66
Primary Completion Date	2021-02-20 , Anticipated
Study Completion Date	2021-02-28 , Anticipated
Name of Study	Yonsei University
Recruitment Status	Recruiting
Date of First Enrollment	2021-02-08 ,

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	Yonsei University
Organization Type	University
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	In general, the musculoskeletal body assessment focuses on measuring joint motion and strength, which can provide sufficient information about the functional level of the entire segment. However, these assessments cannot assess functional movements and biomechanical impairments during work or daily life. Therefore, a functional assessment is needed that includes techniques to assess functional movement and biomechanical damage. Functional assessment can be considered a useful low-cost clinical tool that can provide quantitative data on the functional ability and performance of these bodies. The Closed Kinetic Chain Upper Extremity Stability test is a functional test that provides quantitative data (score) on upper limb function in a closed chain without any special skills. This test counts the number of times you can alternately touch your supporting hand with one hand in a push-up position for 15 seconds. This test is easy for the clinician to apply and for the subject to understand. Previous studies have shown that the closed-chain upper limb stability test is a reliable tool to assess the functional performance of the upper limb in subjects with shoulder impingement syndrome. However, the relationship between the closed-chain upper limb stability test and the anterior serrated and upper triceps muscle strength has not been studied.

Study Summary Information

Lay Summary

In general, the musculoskeletal body assessment focuses on measuring joint motion and strength, which can provide sufficient information about the functional level of the entire segment. However, these assessments cannot assess functional movements and biomechanical impairments during work or daily life. Therefore, a functional assessment is needed that includes techniques to assess functional movement and biomechanical damage. Functional assessment can be considered a useful low-cost clinical tool that can provide quantitative data on the functional ability and performance of these bodies.
  The Closed Kinetic Chain Upper Extremity Stability test is a functional test that provides quantitative data (score) on upper limb function in a closed chain without any special skills. This test counts the number of times you can alternately touch your supporting hand with one hand in a push-up position for 15 seconds. This test is easy for the clinician to apply and for the subject to understand.
  Previous studies have shown that the closed-chain upper limb stability test is a reliable tool to assess the functional performance of the upper limb in subjects with shoulder impingement syndrome. However, the relationship between the closed-chain upper limb stability test and the anterior serrated and upper triceps muscle strength has not been studied.

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	Diagnosis
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	Not Applicable
Intervention Type	Others (The Closed Kinetic Chain Upper Extremity Stability test)
Intervention Description	The Closed Kinetic Chain Upper Extremity Stability test (CKCUES test) is functional test to evaluate the functional performance of the shoulder joint. The CKCUES test scores closed kinetic chain exercise of the upper limbs in an examination of the stability of shoulder. It doesn't require high level technique or preparation, and it is low-cost to conduct. The test consists of how much times, during 15 seconds, the subject in the push-up position is able to touch the supporting hand with the shaking hand. This test is clinically simple to conduct and it is also easy for the subject to understand his physical condition.
Number of Arms	1
Arm 1	Arm Label The Closed Kinetic Chain Upper Extremity Stability test (CKCUES test)
	Target Number of Participant 66
	Arm Type Experimental
	Arm Description The Closed Kinetic Chain Upper Extremity Stability test (CKCUES test) is functional test to evaluate the functional performance of the shoulder joint. The CKCUES test scores closed kinetic chain exercise of the upper limbs in an examination of the stability of shoulder. It doesn't require high level technique or preparation, and it is low-cost to conduct. The test consists of how much times, during 15 seconds, the subject in the push-up position is able to touch the supporting hand with the shaking hand. This test is clinically simple to conduct and it is also easy for the subject to understand his physical condition.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M75.4)Impingement syndrome of shoulder Healthy Volunteers
Rare Disease	No
Inclusion Criteria	Gender Male
	Age 20Year~55Year
	Description Men aged 20-55
Exclusion Criteria	(1) history of total tear in any muscle of shoulder complex and (2) history of luxation or orteoarthrosis in the glenohumeral or acromioclavicular joints and (3) rheumatoid, neurological or degenerative disease and (4) positively to Adison and or Allen tests.
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	serratus anterior strength
Timepoint	Immediately
Secondary Outcome(s) 1
Outcome	triceps brachii strength
Timepoint	Immediately

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	Yes
Time of Sharing	2021. 12
Way of Sharing	To be made available at a later date (wys1595@naver.com)

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