- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03568487
Scapula Adaption in Overhead Athletes
March 17, 2025 updated by: National Taiwan University Hospital
Scapula Adaption in Overhead Athletes: Novel Scapulometer Development, Scapula Movement Adaption and Intensive Scapula-focused Intervention
Previous studies have proposed various ways to assess scapular dyskinesis, but they were impractical in clinical setting or the validity was questioned.
The novel scapulometer we developed can measure the prominence of scapular medial border and inferior angle.
We would like to examine its reliability and validity in subjects with symptomatic scapular dyskinesis.
The long-term, high-intensity, unilateral loading may cause overhead athletes to develop adaptive changes in shoulder kinematics, range of motion (ROM) and strength in the dominant arm.
We hypothesized that these changes may be related to scapular dyskinesis.
According to the previous studies, we expect electromyography (EMG) biofeedback training can help improve the ratio of muscle activation of scapular muscle.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fifty subjects of scapular dyskinesis will be classified and recruited from overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools and through local Internet media.
All participants and their legal guardians will provide written informed assent and consent, respectively, and the study will be approved by the Ethics Committee Institutional Review Board.
Since intervention may be specific to pattern of scapular dyskinesis, pattern of scapular dyskinesis in control group will match the pattern of scapular dyskinesis in the intervention group.
Twenty-five subjects per group is based on a minimal revenant difference of a self-reported functional questionnaire between intervention and control (Struyf et al., 2013; Andersen et al., 2014).
Participants will be recognized as elite players in their age categories.
Subjects will be excluded if they have a history of shoulder pain or injury.
Players will supply their player characteristics, including years of sports practice, weekly sports and conditioning exposure and type of sports.
Players' standing height, sitting height, and body mass will be measured and used with the chronologic age to estimate their biological age according to the assessments of skeletal age, dental age, and secondary sex characteristics (Baxter et al., 2005).
A clinical trial with a blinded assessor will be conducted.
The subject takes a form (with a letter A or B) indicating allocation to either groups (scapula-focused approach versus control) from a closed envelop.
For the scapula-approached group, pattern of scapular dyskinesis will be assessed.
Then subjects in B control group will meet pattern-matched criteria related to pattern assessment of scapula-focused group.
More subjects may be recruited for the control group to meet pattern-matched criteria of scapula-approached group.
A list with subject numbers and the group allocation that results from this matched-control procedure will be stored in a sealed envelope.
Only the therapist has direct access to the allocation list.
In this way, subjects are allocated to either intervention or control group comprised of 25 subjects in each group.
Both groups will be treated by the same therapist.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- (1) with scapular dyskinesis
- (2) overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools
Exclusion Criteria:
- if they have a history of shoulder pain or injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensive scapula-focused approach
|
scapula-focused approach with exercises, 3 x 20 min training per week for 4 weeks
|
|
Active Comparator: Control therapy
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not have any physical training but is encouraged to stay active as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of range of motion after 4-week training
Time Frame: Baseline and after 4-week training
|
Passive interior rotation ROM and exterior rotation ROM of the glenohumeral joint will be assessed bilaterally using a hand-held standard universal goniometer.
The player will lay supine with the humerus abducted to 90 degrees and elbow flexed to 90 degrees.
The fulcrum of the goniometer is set at the olecranon process.
|
Baseline and after 4-week training
|
|
Change of muscle strength after 4-week training
Time Frame: Baseline and after 4-week training
|
The maximal isometric strength of 8 shoulder-scapula complex muscles will be assessed bilaterally using a handheld dynamometer.
Each test will be performed twice, with a 30-second rest period between tests.
The largest strength value for each muscle will be used for statistical analyses, normalized to body weight (in kilograms), and expressed as a percentage for inter individual comparison.
|
Baseline and after 4-week training
|
|
Change of shoulder complex kinematics after 4-week training
Time Frame: Baseline and after 4-week training
|
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) will be used to record shoulder complex kinematics.
|
Baseline and after 4-week training
|
|
Change of muscular activities after 4-week training
Time Frame: Baseline and after 4-week training
|
Bipolar surface electromyographic (EMG) electrodes will be placed over the upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) of the dominant shoulder to record muscular activities.
|
Baseline and after 4-week training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forward shoulder posture (acromial distance)
Time Frame: Baseline and after 4-week training
|
The measurement of the distance between the posterior border of the acromion and the table (acromial distance) is performed in supine.
In this position, the assessor measured the distance between the most posterior aspect of the posterior border of the acromion and the table bilaterally.
|
Baseline and after 4-week training
|
|
Pectoralis minor muscle length
Time Frame: Baseline and after 4-week training
|
The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm.
This distance (in centimeter) is divided by the subjects height and multiplied by 100.
This results in a pectoralis muscle length index (PMI).
|
Baseline and after 4-week training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2019
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
May 30, 2018
First Submitted That Met QC Criteria
June 13, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 17, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201712089RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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