- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06747702
Injury Prevention Programs in Overhead Athletes (IPOverhead)
December 17, 2024 updated by: Monica Solana Tramunt, University Ramon Llull
Effect of Integrated Workouts on Injury Prevention in Overhead Athletes
To evaluate and describe the effect of performing an integrated injury prevention exercises on the variables considered as injury risk factors in overhead athletes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate and describe the effect of performing fast or 6-8 weeks injury prevention programs on the variables considered as injury risk factors in overhead athletes as glenohumeral rotational range of motion or muscle activation pattern and asymmetries.
Study Type
Interventional
Enrollment (Actual)
80
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
-
-
-
Barcelona, Spain, 08022
- FPCEE Blanquerna
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Signing the informed consent according last version ogf Helsinky Declaration.
- Be involved in a overhead sport for a minimum of 2 years.
Exclusion Criteria:
- Have some pain or disconfort to develop the outcome measurements
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: Participants in this group will undergo the intervention
Participants for the injury prevention program
|
The injury prevention workout consisted on engaging on a prevention program from 1 day to 8 weeks where the participants will develop functional sport exercises to prevent shoulder injuries or pain in overhead sports.
|
|
No Intervention: Control group
Participant with same training program that will not be involved in the intervention although they will follow same specific sport practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder ROM
Time Frame: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
Shoulder rotational range of movement will be measured made by a single experienced examiner with the IMU Output Capture (Output V2 Unit, Ireland).
The IMU will be calibrated prior to ROM testing according to the device instructions.
The IMU will be securely attached to the participant's forearm with a self-adhering strap, 10 cm distal to the lateral epicondyle.
Measurements will be sent wirelessly to a tablet and subsequently transferred to the Output Hub specific software to calculate ROM
|
From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
|
Muscle RMS
Time Frame: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
Escapular complex muscular activation EMG recording will be measured with the mDurance® device (mDurance® Solutions SL, Granada, Spain).
The mDurance® system consisted of an EMG Shimmer3 unit (Realtime TechnologiesLtD, Dublin, Ireland).
Muscles-activity data were obtained using a validated surface electromyography (EMG) system.
This novel system includes a us-er-friendly software, and a light hardware, which make it more affordable and accessible for clinicians and sport trainers.
The mDurance® system consisted of an EMG Shimmer3 unit (Realtime TechnologiesLtD, Dublin, Ireland).
The unit has a bipolar surface elec-tromyography bipolar sensor for the acquisition of muscle activity.
Each Shimmer3 has two channels, with a sampling rate of 1024 Hz applying a bandwidth of 8.4 Hz, and a 24-bit signal with an overall amplification of 100 to10,000 v/v [41].
This device is valid and reliable for recording muscle activity during a functional task (ICC = 0.916; 95% CI = 0.831-0.958)
|
From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
|
Muscles Asymetries
Time Frame: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
Diferences in % the muscle activation of the interescapular muscle complex by EMG.
These recording will be also performed with the mDurance® device (mDurance® Solutions SL, Granada, Spain).
The mDurance® system consisted of an EMG Shimmer3 unit (Realtime TechnologiesLtD, Dublin, Ireland) .
This device is valid and reliable for recording muscle activity during a functional task (ICC = 0.916
|
From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
|
Shoulder proprioception
Time Frame: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
The Ability of recognizing a specific glenohumeral rotational range of movement degrees we will use the IMU Output Capture (Output V2 Unit, Ireland).
The IMU was calibrated prior to ROM testing according to the device instructions.
The IMU was securely attached to the participant's forearm with a self-adhering strap, 10 cm distal to the lateral epicondyle.
Measurements were sent wirelessly to a tablet and subsequently transferred to the Output Hub specific software to calculate ROM
|
From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schwank A, Blazey P, Asker M, Moller M, Hagglund M, Gard S, Skazalski C, Haugsbo Andersson S, Horsley I, Whiteley R, Cools AM, Bizzini M, Ardern CL. 2022 Bern Consensus Statement on Shoulder Injury Prevention, Rehabilitation, and Return to Sport for Athletes at All Participation Levels. J Orthop Sports Phys Ther. 2022 Jan;52(1):11-28. doi: 10.2519/jospt.2022.10952.
- Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.
- McKenzie A, Larequi SA, Hams A, Headrick J, Whiteley R, Duhig S. Shoulder pain and injury risk factors in competitive swimmers: A systematic review. Scand J Med Sci Sports. 2023 Dec;33(12):2396-2412. doi: 10.1111/sms.14454. Epub 2023 Jul 28.
- Wright AA, Ness BM, Donaldson M, Hegedus EJ, Salamh P, Cleland JA. Effectiveness of shoulder injury prevention programs in an overhead athletic population: A systematic review. Phys Ther Sport. 2021 Nov;52:189-193. doi: 10.1016/j.ptsp.2021.09.004. Epub 2021 Sep 14.
- Liaghat B, Pedersen JR, Husted RS, Pedersen LL, Thorborg K, Juhl CB. Diagnosis, prevention and treatment of common shoulder injuries in sport: grading the evidence - a statement paper commissioned by the Danish Society of Sports Physical Therapy (DSSF). Br J Sports Med. 2023 Apr;57(7):408-416. doi: 10.1136/bjsports-2022-105674. Epub 2022 Oct 19.
- Cools AM, Maenhout AG, Vanderstukken F, Decleve P, Johansson FR, Borms D. The challenge of the sporting shoulder: From injury prevention through sport-specific rehabilitation toward return to play. Ann Phys Rehabil Med. 2021 Jul;64(4):101384. doi: 10.1016/j.rehab.2020.03.009. Epub 2020 Apr 29.
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)
September 2, 2024
Primary Completion (Actual)
December 4, 2024
Study Completion (Actual)
December 4, 2024
Study Registration Dates
First Submitted
December 6, 2024
First Submitted That Met QC Criteria
December 17, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 17, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Injury prevention Overhead
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not proceed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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