Status Approved
First Submitted Date
2020/05/19
Registered Date
2020/05/22
Last Updated Date
2020/05/21
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005050 |
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Unique Protocol ID | 1041849-201906-BM-097-01 |
Public/Brief Title | Muscle activity and activity ratio during scapular upward rotator strengthening exercises |
Scientific Title | Comparison of the scapular upward rotator muscle activity and activity ratio during three scapular upward rotator strengthening exercises |
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
Board Approval Status | Submitted approval |
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Board Approval Number | 1041849-201906-BM-097-01 |
Approval Date | 2019-07-01 |
Institutional Review Board Name | Yonsei University Mirae Institutional Review Board |
Institutional Review Board Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Korea |
Institutional Review Board Telephone | 033-760-5247 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Oh-yun Kwon |
Title | Professor |
Telephone | +82-33-760-2971 |
Affiliation | Yonsei University |
Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Korea |
Contact Person for Public Queries | |
Name | Jun-hee Kim |
Title | Doctor of Philosophy |
Telephone | +82-33-760-2971 |
Affiliation | Yonsei University |
Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Korea |
Contact Person for Updating Information | |
Name | Jun-hee Kim |
Title | Doctor of Philosophy |
Telephone | +82-33-760-2971 |
Affiliation | Yonsei University |
Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-07-29 Actual | |
Target Number of Participant | 29 | |
Primary Completion Date | 2019-11-11 , Actual | |
Study Completion Date | 2019-11-25 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-07-29 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University |
Organization Type | University |
Project ID | 1041849-201906-BM-09 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
Lay Summary | The scapular upward rotation is important for the upper limbs to function normally. If scapula do not perform their original function and do not conduct correct upward rotation, the scapula is out of the normal position, which may cause shoulder diseases such as shoulder impingement syndrome. If there is a structural problem in the scapula or a problem in the function of the surrounding muscles, an abnormal problem occurs in the position and movement of the scapula, resulting in an imbalanced muscle, which in turn causes dysfunction of the shoulder joint. Rotator muscles of the shoulders are important muscles in maintaining the normal movement of the upper arm joint while raising the arm. Among the rotator muscles of the shoulder, the upper trapezius muscle rotates upward by pulling the scapula upwards and inwards when the humerus moves to raise the arm such as flexion or abduction. Along with this, the serratus anterior muscle helps keep the scapula attached to the chest when the humerus perform flexion, abduction, etc., and prevents the scapula from elevating and causes an upward rotation. The lower trapezius pulls the scapula downwards and inwards, helping to rotate upwards, while preventing the scapula from elevating excessively. These rotator muscles of the shoulder show abnormal muscle activity in various pathological conditions of the shoulder. People with shoulder impingement syndrome reported excessive contraction of the upper trapezius muscle when performing the arm raising motion compared to those who did not. At the same time, it was said that the muscles strength of the lower trapezius and serratus anterior muscles were weakened. Several methods were used to strengthen the rotator muscles of the shoulder. Among these, the scaption motion showed high muscle activity in all the muscles of the scapular upward rotation. However, excessive upper trapezius muscle activity has been reported to cause shoulder pain. Therefore, the protraction exercise was used to induce low muscle activity of the upper trapezius muscle and high muscle activity of the serratus anterior muscle. However, when performing this motion, the muscle activity of the serratus anterior muscle was significantly lower than that of other motions. In order to solve the above problems, the scapular upward rotation movement of the scapula was devised to significantly reduce the muscle activity of the upper trapezius muscle and increase the muscle activity of the serratus anterior muscle. However, there was no study comparing the muscle activity of the rotator muscles and their proportions during these exercises. To date, there have been no studies on muscle activity of the three muscles or the ratio of muscle activity to the muscles during scapula rotational resistance exercise. So, we wanted to find out what the difference in muscle activity of the three muscles is when performing scapular upward rotation, protraction, and scaption exercises. Then, we want to see if there is a difference in the ratio between the scapular rotator muscles. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Cross-sectional |
Target Number of Participant | 29 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Scapular upward rotation exercise group |
Cohort/Group Description Measurement of muscle activity during Scaption, Protraction, and Scapular upward rotation exercise by attaching electrodes to the skin surface of the upper, lower trapezius and serratus anterior muscles |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Healthy adult men in their 20s to 30s in Wonju |
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Sampling Method | simple random sampling |
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M75.4)Impingement syndrome of shoulder Shoulder pain and shoulder impingement syndrome - Pain caused by damage to the muscles, ligaments, and other structures in the shoulder region, or pain caused by impingement of structures that form the shoulder joint. |
Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 18Year~30Year |
|
Description Healthy people in their 20s and 30s with no shoulder pain or abnormalities |
|
Exclusion Criteria |
Those under 18 years of age Those who have continuous pain or surgical experience in the shoulder joint Those with experience in shoulder dislocation or fracture People with acute pain around the shoulder People with pain or neurological problems on the shoulder |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Muscle activities of upper trapezius, lower trapezius, serratus anterior |
|
Timepoint | during scaption, protracion, scapular upward rotation exercise |
|
Secondary Outcome(s) 1 | ||
Outcome | Muscle activity ratio |
|
Timepoint | after scaption, protracion, scapular upward rotation exercise |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2021. 1 |
Way of Sharing | Available on Request
(kemakjh@naver.com) |
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