Skip to main content
Clinical Trials/NCT07115225
NCT07115225
Recruiting
Not Applicable

Predictive Validity of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation: a Prospective Study

University Ghent2 sites in 1 country129 target enrollmentStarted: July 3, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
129
Locations
2
Primary Endpoint
Subjective Patient Outcome for Return to Sports (SPORTS) score

Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
16 Years to 55 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Subjective Patient Outcome for Return to Sports (SPORTS) score

Time Frame: 3 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)

Time Frame: 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 Outcomes

  • Re-injury(3 months, 6 months, 9 months, 12 months post-return to sport)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials