- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271902
Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program Among Youth Volleyball Athletes in Singapore
Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program (YoSO-IPP) Among Youth Volleyball Athletes in Singapore: a Randomized Controlled Trial
The Singapore Youth Shoulder Overuse Injury Prevention Program (YoSO-IPP) includes an exercise segment and an education segment. This study will (1) assess the effects of the exercise segment, and (2) assess the effects of the education segment among youth volleyball athletes using a randomized controlled trial over 12 weeks. Performance outcome measures of shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion will be used to assess the effects of the exercise segment. Knowledge scores via an online questionnaire will be used to assess the effects of the education segment.
Hypothesis: The YoSO-IPP will have an effect on shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion and on knowledge scores.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A randomized controlled trial study design will be utilized to assess the effects of YoSO-IPP over 12 weeks. A within-team randomization will be conducted. This is to ensure a good balance between the intervention and control groups as different teams have different training regimes, training frequencies and training intensities.
Participants in the intervention group will be required to perform the exercise segment of YoSO-IPP for 12 weeks, at a recommended frequency of two times per week - (a) cross-body stretch, (b) eccentric external rotation shoulder strength exercise, (c) trunk rotation, and (d) modified cat-cow thoracic mobility exercise.
Participants in the control group will be required to perform lower body stretches for 12 weeks, at a recommended frequency of two times per week - (a) double leg calf stretch, (b) quadriceps stretch, (c) hip flexor stretch, (d) seated single leg hamstring stretch, and (e) seated single gluteal stretch. This stretching program is considered a sham program in this study as it does not target the upper extremity and the stretches are only held for 10 seconds.
Participants in both groups will each receive an instruction booklet for their respective program. Respective instructional videos will also be distributed. For the following 12 weeks, participants are to perform the exercises at a recommended frequency of two times per week. They will also be required to report the number of times they performed their respective programs that week via an online questionnaire weekly.
Participants who are randomized into the intervention group will attend an online 45-minute educational workshop in Week 1. This is the education segment of YoSO-IPP. Participants who are randomized into the control group will not attend the online 45-minute educational workshop.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mukherjee
- Phone Number: +65-67903680
- Email: swarup.mukherjee@nie.edu.sg
Study Locations
-
-
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Singapore, Singapore
- Nanyang Technological University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 12 to 18 years old youth athlete; in the sport of volleyball; trains with an aim to compete; currently NOT undergoing any shoulder or elbow overuse injury prevention program
Exclusion Criteria:
- Below 12 and above 18 years old; not in the sport of volleyball; trains without an aim to compete; currently undergoing a shoulder or elbow overuse injury prevention program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Participants will be instructed to perform YoSO-IPP at a recommended frequency of two times per week for 12 weeks and attend an online 45-minute educational workshop in Week 1
|
A 10-minute, 4-exercises program that targets shoulder eccentric external rotation strength, shoulder internal rotation range of morion, and thoracic rotation range of motion.
The topic for the 45-minute educational workshop will be on overuse injuries among youth athletes.
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Active Comparator: Control group
Participants will be instructed to perform the lower body stretching program at a recommended frequency of two times per week.
|
A 10-minute, 5-stretches sham exercise program that does not target the upper extremity and are only held for 10 seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder external rotation strength
Time Frame: Baseline (Week 0), Week 6, Week 12
|
Shoulder external rotation strength is a performance outcome measure of interest.
It will be measured using a handheld electronic dynamometer.
It will be presented in Newtons (N).
|
Baseline (Week 0), Week 6, Week 12
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Internal rotation range of motion
Time Frame: Baseline (Week 0), Week 6, Week 12
|
Shoulder internal rotation range of motion is a performance outcome measure of interest.
It will be measured using 'Clinometer', a validated phone application for range of motion measurement.
It will be presented in degrees (°).
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Baseline (Week 0), Week 6, Week 12
|
Thoracic rotation range of motion
Time Frame: Baseline (Week 0), Week 6, Week 12
|
Thoracic rotation range of motion is a performance outcome measure of interest.
It will be measured using 'Clinometer', a validated phone application for range of motion measurement.
It will be presented in degrees (°).
|
Baseline (Week 0), Week 6, Week 12
|
Knowledge of overuse injuries
Time Frame: Baseline (Week 0), Week 12
|
Knowledge scores will be calculated based on a novel questionnaire concerning youth athletes and overuse injuries.
The scores will range from 0 to 20, with higher scores indicating a better outcome.
|
Baseline (Week 0), Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder overuse injury prevalence
Time Frame: Baseline (Week 0), Week 12
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Injury prevalence will be determined based on the Youth Overuse Injury Questionnaire (YOvIQ).
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Baseline (Week 0), Week 12
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Elbow overuse injury prevalence
Time Frame: Baseline (Week 0), Week 12
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Injury prevalence will be determined based on the Youth Overuse Injury Questionnaire (YOvIQ).
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Baseline (Week 0), Week 12
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Shoulder overuse injury severity
Time Frame: Baseline (Week 0), Week 12
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Injury severity will be determined based on the Youth Overuse Injury Questionnaire (YOvIQ).
Severity score will range from 0 to 100, with higher scores indicating a more severe injury.
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Baseline (Week 0), Week 12
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Elbow overuse injury severity
Time Frame: Baseline (Week 0), Week 12
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Injury severity will be determined based on the Youth Overuse Injury Questionnaire (YOvIQ).
Severity score will range from 0 to 100, with higher scores indicating a more severe injury.
|
Baseline (Week 0), Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mukherjee, Nanyang Technological University, National Institute of Education
Publications and helpful links
General Publications
- Lau R, Mukherjee S. Prevalence of Shoulder and Elbow Overuse Injuries Among Competitive Overhead Youth Athletes in Singapore. Orthop J Sports Med. 2023 Mar 21;11(3):23259671231156199. doi: 10.1177/23259671231156199. eCollection 2023 Mar.
- Lau R, Mukherjee S. Developing the Singapore youth shoulder overuse injury prevention program. Phys Ther Sport. 2024 Jan;65:30-37. doi: 10.1016/j.ptsp.2023.11.001. Epub 2023 Nov 16.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2023-531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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