- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875596
The Effectiveness of an Exercise Program on Scapulohumeral Rhythm, Range of Motion, and Stability in Young Female Handball Players
The Effectiveness of an Exercise Program on Scapulohumeral Rhythm, Range of Motion, and Shoulder Girdle Stability in Young Female Handball Players
Study Overview
Status
Conditions
Detailed Description
The aim of this study is to investigate the effects of a structured shoulder girdle exercise programme on stability, range of motion (ROM) and motor control in female handball players. The study will be conducted over a period of 8 weeks and will involve 60 participants aged 17-30 years recruited from professional handball clubs. Participants will be randomly assigned to either the experimental group, which will follow a modified version of the Watson programme, or the control group, which will continue with their standard training programme. Aims: - To compare the effects of the upper scapular rotation-oriented exercise intervention with a standardised upper extremity exercise programme. - Scapulohumeral rhythm assessment: To assess scapulohumeral rhythm at different angles of shoulder flexion (30°, 60°, 90° and 120°) in young female handball players, with a focus on identifying potential asymmetries between the dominant and non-dominant limbs. - Analysis of scapular kinematics: To measure scapular upward rotation, anterior/posterior tilt and medial/lateral translation at different degrees of shoulder flexion to identify movement patterns associated with scapular dyskinesis. - Functional stability analysis: To assess upper extremity functional stability using the Y-Balance Upper Quarter Test (YBT-UQ) and the Closed Kinetic Chain Upper Extremity Stability Test pre- and post-exercise to identify potential correlations between stability improvements and changes in scapular rhythm and muscle activation. - Isometric strength measurement: To evaluate isometric strength in shoulder abduction, internal rotation and external rotation using the Lafayette HHD handheld dynamometer to assess the impact of the intervention on shoulder muscle performance.
An internal pilot phase of this registered study was conducted between March and September 2025 to assess feasibility, retention, adherence, safety, and preliminary variability of outcome measures before progression to the full trial. Seventeen participants were enrolled and 14 completed post-intervention assessment. Findings from this pilot phase are being reported separately in a manuscript focused on feasibility and preliminary effect estimation. The definitive randomized trial remains planned contingent on feasibility findings and available resources.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Poland, 80-211
- Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy individuals with no reported health problems
- No history of shoulder or elbow surgery within the past 2 years
- Received information about the study
- Written consent from the participant to participate in the study, including video recording and photography
Exclusion criteria:
- Injury or trauma to the upper extremity within the past 3 months
- Illness that prevents participation in the study or tests
- Heavy physical activity of the shoulder girdle within 2 hours prior to the study
- Orthopedic surgery or physiotherapy treatment of the shoulder girdle
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Modified Watson-based scapular exercise program
Participants undergo baseline and post-intervention assessment including scapulohumeral rhythm, range of motion, isometric shoulder strength, Upper Quarter Y-Balance Test, and Closed Kinetic Chain Upper Extremity Stability Test.
The intervention lasts 8 weeks and is divided into four consecutive 2-week phases targeting the dominant upper extremity.
Participants receive scapular positioning correction and scapular-specific cueing aimed at improving upward rotation and neuromuscular control during exercise performance.
Two elastic resistance bands are used: one to facilitate scapular upward rotation control and one to provide external resistance during the exercises.
Participants are instructed to perform the home exercise program daily for approximately 10 minutes.
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An 8-week dominant-limb exercise program based on the Watson rehabilitation approach, incorporating scapular positioning correction, scapular-specific cueing, and progressive exercises performed with two elastic resistance bands.
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Active Comparator: Active Comparator: Standard upper-limb exercise program
Participants undergo baseline and post-intervention assessment including scapulohumeral rhythm, range of motion, isometric shoulder strength, Upper Quarter Y-Balance Test, and Closed Kinetic Chain Upper Extremity Stability Test.
The control intervention lasts 8 weeks and is divided into four consecutive 2-week phases targeting the dominant upper extremity.
Participants perform a standardized upper-limb exercise program without scapular positioning correction, without scapular-specific cueing, and without specific upward-rotation facilitation.
One elastic resistance band is used to provide external resistance during the exercises.
Participants are instructed to perform the home exercise program daily for approximately 10 minutes.
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An 8-week dominant-limb standardized upper-limb exercise program performed with one elastic resistance band and without scapular positioning correction or scapular-specific cueing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scapulohumeral rhythm
Time Frame: through study completion, an average of 2 years
|
Scapular upward rotation is assessed with the Digital Inclinometer (BASELINE 12-1057) in a seated position to minimize compensatory movements of the trunk and lower extremities.
The first measurement is taken at baseline (0° of shoulder flexion), followed by additional measurements at 30°, 60°, 90°, and 120° of shoulder flexion.
Each position is held for 10-15 seconds to ensure stable measurement conditions.
Measurements are repeated three times and the average is used for analysis.
The assessment will be performed on both the dominant and non-dominant upper limb to evaluate movement symmetry.
Data will be recorded manually by a research assistant to reduce the risk of reading errors and to ensure measurement accuracy.
Statistical analysis will be performed to determine the scapulohumeral rhythm across different ranges of motion and to identify potential movement asymmetries.
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through study completion, an average of 2 years
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ISOMETRIC STRENGTH TEST - Internal and External Rotation
Time Frame: through study completion, an average of 2 years
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Isometric strength assessment of the shoulder girdle muscles will be conducted using the Lafayette Hand-Held Dynamometer (HHD).
For the rotator muscles, measurements will be performed in the prone position with the shoulder abducted to 90° and the elbow flexed to 90°, with the forearm hanging freely over the edge of the examination table.
This setup will be used for both internal and external rotation strength assessments.
Results are expressed in Newtons (N) or normalized to body weight as Newtons per kilogram (N/kg).
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through study completion, an average of 2 years
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Y-Balance Upper Quarter Test (YBT-UQ)
Time Frame: through study completion, an average of 2 years
|
The Y-Balance Upper Quarter Test (YBT-UQ) is used to assess upper extremity stability and reach performance. The test requires the participant to maintain a single-arm support position while the opposite arm performs reaching movements in three directions: anterior (forward), inferolateral (diagonally opposite the supporting hand), and superolateral (diagonally toward the supporting hand). Each reach is measured in centimeters, and the final score for each direction is calculated as the average of three trials. The test will be performed on both upper limbs and arm length will be included in the analysis to ensure standardized results. Results will be reported in centimeters, "cm", and Upper Limb Length % (standardized by upper limb length). |
through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Closed Kinetic Chain Upper Extremity Stability Test
Time Frame: through study completion, an average of 2 years
|
Two strips of tape will be placed on the floor 90 cm apart. Participants will be instructed to assume a push-up position and perform as many hand touches as possible on each strip within 15 seconds. The examiner will count the number of touches. Three trials will be conducted, and the final score will be calculated as the average number of touches across all three trials. A 45-second rest period will be provided between each trial. The CKCUEST score and CKCUEST power will be calculated using the following formulas:
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through study completion, an average of 2 years
|
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RANGE OF MOTION (Shoulder Internal and External Rotation)
Time Frame: through study completion, an average of 2 years
|
Range of motion is measured for internal and external rotation of the shoulder.
The participant is positioned in the prone position with the shoulder abducted to 90 degrees and the elbow flexed to 90 degrees, allowing the forearm to hang freely over the edge of the examination table.
The starting position (0 degrees) is defined as the forearm being vertically aligned.
Results are presented in degre
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through study completion, an average of 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bartosz Wilczyński, Medical University of Gdansk
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KB/42/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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