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HealthyIPOverheadNCT06747702

Injury Prevention Programs in Overhead Athletes

A study testing Injury prevention workout in people with Healthy and Shoulder Impingement Syndrome, run by University Ramon Llull at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate and describe the effect of performing an integrated injury prevention exercises on the variables considered as injury risk factors in overhead athletes Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Injury prevention workout
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
2 Sep 2024to 4 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Signing the informed consent according last version ogf Helsinky Declaration.
  • Be involved in a overhead sport for a minimum of 2 years.

Who cannot join

  • Have some pain or disconfort to develop the outcome measurements

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • FPCEE Blanquerna

    Barcelona, Barcelona, 08022

Other trials in Spain

About this study

Official title: 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

Read the 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.

Being tested
Injury prevention workout
Keywords
Injury prevention, Glenohumeral rotation deficits, Overhead athletes, shoulder pain, Shoulder instability, Shoulder mobility, Shoulder exercises, Shoulder symetries, Shoulder Asymetries, Shoulder stability, Shoulder strength, Escapulahumeral complex
Medical subject headings
Shoulder Impingement Syndrome, Shoulder Injuries, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injury prevention workoutOther

    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.

Study groups in NCT06747702
Study groupRoleWhat they receive
Experimental Group: Participants in this group will undergo the interventionExperimentalParticipants for the injury prevention program
Receives: Other: Injury prevention workout
Control groupNo interventionParticipant with same training program that will not be involved in the intervention although they will follow same specific sport practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shoulder ROM

    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

    Measured: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks

  2. Muscle RMS

    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)

    Measured: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks

  3. Muscles Asymetries

    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

    Measured: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks

  4. Shoulder proprioception

    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

    Measured: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start2 Sep 2024
  3. Primary completion4 Dec 2024
  4. Study completion4 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06747702
Sponsor's protocol ID
Injury prevention Overhead
Acronym
IPOverhead
Status last verified
Dec 2024
First submitted
6 Dec 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not proceed

Publications

  • 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.

    PubMed 37515375

  • 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.

    PubMed 26537804

  • 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.

    PubMed 34560586

  • 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.

    PubMed 36261251

  • 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.

    PubMed 34972489

  • 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.

    PubMed 32320753

  • Solana-Tramunt M, Bofill-Rodenas A. Motor imagery enhances core training effects on lumbar proprioception in elite swimmers: a randomized controlled trial. Front Physiol. 2025 Sep 1;16:1667536. doi: 10.3389/fphys.2025.1667536. eCollection 2025.

    PubMed 40959125

Questions about this trial

What is this clinical trial studying?

A study testing Injury prevention workout in people with Healthy and Shoulder Impingement Syndrome, run by University Ramon Llull at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder ROM (time frame: From enrollment to the end of the intervention at 8 weeks. Follow-up at 12-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06747702, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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Injury Prevention Programs in Overhead Athletes | AzTrials