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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06271902
Other study ID # IRB-2023-531
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date June 2024

Study information

Verified date February 2024
Source Nanyang Technological University
Contact Mukherjee
Phone +65-67903680
Email swarup.mukherjee@nie.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Intervention

Other:
Singapore Youth Shoulder Overuse Injury Prevention Program
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.
Lower body stretching program
A 10-minute, 5-stretches sham exercise program that does not target the upper extremity and are only held for 10 seconds.

Locations

Country Name City State
Singapore Nanyang Technological University Singapore

Sponsors (1)

Lead Sponsor Collaborator
Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder external rotation strength 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
Primary Internal rotation range of motion 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 (°). Baseline (Week 0), Week 6, Week 12
Primary Thoracic rotation range of motion 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
Primary Knowledge of overuse injuries 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
Secondary Shoulder overuse injury prevalence Injury prevalence will be determined based on the Youth Overuse Injury Questionnaire (YOvIQ). Baseline (Week 0), Week 12
Secondary Elbow overuse injury prevalence Injury prevalence will be determined based on the Youth Overuse Injury Questionnaire (YOvIQ). Baseline (Week 0), Week 12
Secondary Shoulder overuse injury severity 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
Secondary Elbow overuse injury severity 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
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