Status Approved
First Submitted Date
2017/07/24
Registered Date
2017/09/22
Last Updated Date
2017/08/24
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002474 |
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Unique Protocol ID | INJE 2017-03-004-001 |
Public/Brief Title | Comparison of muscle activity between serratus anterior and pectoralis major during shoulder isometric strength test |
Scientific Title | Isometric Shoulder Protraction Strength and Muscle Activity of Pectoralis Major and Serratus Anterior in Supine- and Sitting- Positions |
Acronym | ISPSAPM |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | INJE 2017-03-004-001 |
Approval Date | 2017-05-02 |
Institutional Review Board Name | Inje University Ethics Committe for Human Investigations |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jae-seop Oh |
Title | proffessor |
Telephone | +82-55-320-3679 |
Affiliation | Inje University |
Address | Seong-san-gwan 511,197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Jun-seok Kim |
Title | researcher |
Telephone | +82-55-320-3849 |
Affiliation | Inje University |
Address | Il-gang-won 703,197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea |
Contact Person for Updating Information | |
Name | Jun-seok Kim |
Title | researcher |
Telephone | +82-55-320-3849 |
Affiliation | Inje University |
Address | Il-gang-won 703,197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-08-28 Anticipated | |
Target Number of Participant | 18 | |
Primary Completion Date | 2017-12-31 , Anticipated | |
Study Completion Date | 2017-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inje University | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-08-28 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Inje University |
Organization Type | University |
Project ID | 20170065 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inje University |
Organization Type | University |
7. Study Summary
Lay Summary | <Purpose> ● the purpose of this study was to examine the isometric strength of the SA muscle and EMG activity of the SA and PM muscles during measurement of isometric protraction strength. <BACKGROUND> - Measurements isolating serratus anterior (SA) from pectoralis major (PM) muscle activity and strengthening the SA during isometric shoulder protraction have been considered primary goals in regaining functional motion and stability of the scapula. - In previous studies examining the optimal position for measuring SA muscle activity in motions related to scapular upward rotation of >120–150° of shoulder flexion, a sitting position was found to produce greater electromyographic (EMG) activity in the SA than straight shoulder protraction - however, many patients with shoulder impingement or rotator cuff tears may be able to exercise with a low load and range of motion in shoulder flexion as long as the painful arc of motion is avoided. For this reason, many authors have recommended scapular protraction in a different position, with shoulder flexion at 90°, for SA strengthening exercises in the earlier stages of a rehabilitation program - It is also important to consider the optimal position to measure shoulder protraction strength, which may also be needed to derive the appropriate muscle strength and activity of the SA in the absence of pain. - it remains unclear whether the designated muscle, i.e., the SA, in a given scapular MMT makes a greater contribution than the PM muscle during isometric protraction in different positions under the specified MMT. - No reported study has investigated isometric protraction strength when MMTs are performed, and none has compared SA and PM activity. <Hypothesis> - SA muscle activity and shoulder isometric protraction stregnth is greater and PM activity is lower in sitting position than conditions in supine position <METHODS> In total, 18 healthy subjects performed isometric shoulder protraction in supine and sitting positions with 90° shoulder flexion. Surface electromyography (EMG) data of the SA and PM muscles and SA strength were examined simultaneously using fixed-based instrumentation, custom designed for measuring the force of isometric shoulder protraction. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Cross-sectional |
Target Number of Participant | 18 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label a single group |
Cohort/Group Description In a single group, the shoulder isometric protraction strength, the muscle activity of serratus anterior and pectoralis major are measured respectively in the supine-lying position and the sitting position. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | healthy male volunteers who attending Inje University in Gimhae |
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Sampling Method | The sampling method is non-probablitic methods for selecting males. The sample size is determined from previous studies (Ekstrom et al., 2005) that showed significant differences in muscle activity of the SA between different positions. The power analysis indicate that at least six subjects would be required to achieve a power of 0.96 with an effect size of 1.93 at a significance level of 0.05. |
Condition(s)/Problem(s) | Not Applicable-Etc |
Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 20Year~35Year |
|
Description - right handed - free from past or current shoulder pain - no limit on the full range of motion for the shoulder joint |
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Exclusion Criteria |
Subjects who had a history of shoulder surgery or disorder, such as tendonitis, adhesive capsulitis, impingement, or a neurological disorder involving long thoracic nerve injury were excluded |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | shoulder isometric protraction strength |
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Timepoint | supine position and sitting position |
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Secondary Outcome(s) 1 | ||
Outcome | muscle activity of serratus anterior |
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Timepoint | supine position and sitting position |
|
Secondary Outcome(s) 2 | ||
Outcome | muscle activity of pectoralis major |
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Timepoint | supine position and sitting position |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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