NCT06747702

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 6, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

Injury preventionGlenohumeral rotation deficitsOverhead athletesshoulder painShoulder instabilityShoulder mobilityShoulder exercisesShoulder symetriesShoulder AsymetriesShoulder stabilityShoulder strengthEscapulahumeral complex

Outcome Measures

Primary Outcomes (4)

  • 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

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

  • 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)

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

  • 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

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

  • 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

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

Study Arms (2)

Experimental Group: Participants in this group will undergo the intervention

EXPERIMENTAL

Participants for the injury prevention program

Other: Injury prevention workout

Control group

NO INTERVENTION

Participant with same training program that will not be involved in the intervention although they will follow same specific sport practice

Interventions

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.

Experimental Group: Participants in this group will undergo the intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Have some pain or disconfort to develop the outcome measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FPCEE Blanquerna

Barcelona, Barcelona, 08022, Spain

Location

Related Publications (7)

  • 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.

    PMID: 37515375BACKGROUND
  • 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.

    PMID: 26537804BACKGROUND
  • 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.

    PMID: 34560586BACKGROUND
  • 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.

    PMID: 36261251BACKGROUND
  • 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.

    PMID: 34972489BACKGROUND
  • 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.

    PMID: 32320753BACKGROUND
  • 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.

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware of whether they belong to the experimental or control group. They will receive instructions on their workout regimen without information on the study's hypothesis regarding functional prevention training. Individuals conducting pre- and post-intervention assessments (e.g., EMG analysis, ROM measurements, proprioception tests) will not be informed of the participant group allocation. This prevents bias in data collection and interpretation. Data will be anonymized before analysis, and analysts will not have access to group identifiers during the statistical evaluation phase.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 24, 2024

Study Start

September 2, 2024

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Not proceed

Locations