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Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation

Not Applicable
Recruiting
Conditions
Return to Sport
Shoulder Dislocation or Subluxation
Registration Number
NCT07115225
Lead Sponsor
University Ghent
Brief Summary

The goal of this exploratory prospective study is to determine if an upper extremity test battery, comprised of physical performance tests, analytical tests and patient-reported outcome measures, can predict successful return to sports and quality of life in athletes (age 16-55) after shoulder dislocation.

The main research questions are:

* Can an Upper Extremity Physical Performance Test Battery predict successful return to sports (= return to pre-injury sports level) in athletes after shoulder stabilization procedure

* Can an Upper Extremity Physical Performance Test Battery predict the quality of life in athletes after shoulder stabilization procedure

Participants will:

* Fill out questionnaires pre-operatively

* Fill out the SIRSI questionnaire throughout the rehabilitation

* Undergo a testing battery in the return to sport phase, including physical performance tests, analytical tests and patient-reported outcome measures

* Fill out questionnaires every 3 months after return to sports, up to 1 year.

Detailed Description

After enrollment, athletes will be asked about their injury history, and demographic information will also be collected, including gender, age, athlete experience, and sports level. During rehabilitation (duration: typically between 3 and 6 months), the participant will be given a monthly questionnaire that surveys their rehabilitation progress. At the time they return to sport (after green light by orthopaedic surgeon and physiotherapist), they are tested once with the test battery (physical performance tests, analytical tests and patient-reported outcome measures). Patients will be tested as close as possible to the actual return to sport timing. Following, they are monitored for another year with questionnaires, every 3 months, that survey their pain, current level of competition, quality of life, confidence in the shoulder and possible re-injuries. This way, the included participants will be monitored for +- 18 months (duration of rehabilitation + 1 year follow-up after return to sport).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
129
Inclusion Criteria
  • Practising sports with moderate to high demand on the shoulder (based on Degree of Shoulder Involvement in Sport (DOSIS) scale), minimal weekly 3 hours
  • Shoulder instability event (anterior direction)
  • Healthy contralateral shoulder
  • Completion of the postoperative rehabilitation protocol
Exclusion Criteria
  • Other upper limb pathologies/ associated injuries: e.g. posterior instability, or rotator cuff tear,...
  • Being pregnant
  • No intention to return to pre-injury sport

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Subjective Patient Outcome for Return to Sports (SPORTS) score3 months, 6 months, 9 months, 12 months post-return to sport

Subjective Patient Outcome for Return to Sports (SPORTS) score is a single-item scale that measures athletes' ability to return to their preinjury sport based on effort and performance. It is scored on a 10-point scale with 0 points allocated to the patient who does not resume the same sport and 10 points to the patient who is able to perform, without pain, the same sport, at same level of effort and performance as before the onset of his/her impairment.

Western Ontario Shoulder Instability Index (WOSI)pre-operatively; in return to sport phase; 3 months, 6 months, 9 months, 12 months post-return to sport

The WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with shoulder instability. It consists of four subscales with a total of 21 items. Each question in this version is scaled on a Numerical Rating Scale from 0 (best) to 10 (worst), with the WOSI score ranging from 0 (highest shoulder-related quality of life) to 210 (worst shoulder-related quality of life).

Secondary Outcome Measures
NameTimeMethod
Re-injury3 months, 6 months, 9 months, 12 months post-return to sport

The questionnaire will capture re-injuries and subsequent injuries within 12 months after return to sport

Trial Locations

Locations (2)

AZ Monica, Deurne - Orthopedie

🇧🇪

Antwerpen, Belgium

Department of rehabilitation sciences, Ghent university

🇧🇪

Gent, Belgium

AZ Monica, Deurne - Orthopedie
🇧🇪Antwerpen, Belgium

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