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

NCT07115225 | Recruiting

• 1 other identifier: ONZ-2024-0629
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

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.

Conditions

Return to Sport; Shoulder Dislocation or Subluxation

Outcome Measures

Primary Outcomes (2)

• Subjective Patient Outcome for Return to Sports (SPORTS) score

  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.

  3 months, 6 months, 9 months, 12 months post-return to sport

• Western Ontario Shoulder Instability Index (WOSI)

  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).

  pre-operatively; in return to sport phase; 3 months, 6 months, 9 months, 12 months post-return to sport

Secondary Outcomes (1)

• Re-injury

  3 months, 6 months, 9 months, 12 months post-return to sport

Study Arms (1)

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

EXPERIMENTAL

Patients who underwent shoulder stabilization surgery (Latarjet or Bankart procedure) between the ages of 16 and 55 years old

Other: Analytical test - Shoulder Range of Motion (ROM); Other: Analytical test - Shoulder Strength; Other: Modified-Athletic Shoulder Test (M-AST); Other: Physical performance test - Unilateral Seated Shot-Put Test (USSPT); Other: Physical performance test - modified-Closed Kinetic Chain Upper Extremity Stability Test (m-CKCUEST); Other: Supine moving apprehension test (SMAT); Other: Physical performance test - Posterior shoulder endurance test (PSET); Other: Patient-reported outcome measure - The Shoulder Instability-Return to Sport after Injury (SIRSI); Other: Patient-reported outcome measure - Numeric Pain Rating Scale (NPRS); Other: Modified Tampa-Scale of Kinesiophobia for Anterior Shoulder Instability (TSK-SI)

Interventions

Analytical test - Shoulder Range of Motion (ROM) OTHER

Passive external rotation in supine position with arm in 90° abduction - passive internal rotation in supine position with arm in 90° abduction.

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Analytical test - Shoulder Strength OTHER

Shoulder external rotation and internal rotation measured with a hand held dynanometer in supine lying

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Modified-Athletic Shoulder Test (M-AST) OTHER

Shoulder strength in the antero-posterior plane measured with a hand held dynanometer in prone lying

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Physical performance test - Unilateral Seated Shot-Put Test (USSPT) OTHER

Set up requires that the subject is placed in a seated position (knees bent at 90° degrees) with their back against the wall, and a 3 kg medicine ball held at height of the shoulder. When ready, the subject will perform a shot put motion to push the medicine ball as far as possible in a horizontal direction. The average of three trials is recorded for each arm.

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Physical performance test - modified-Closed Kinetic Chain Upper Extremity Stability Test (m-CKCUEST) OTHER

The test is performed in a push-up position with the hands one half-arm span apart on strips of athletic tape. The person reaches with alternating hands across the body to touch the piece of tape under the opposing hand. The number of cross-body touches performed in 15 seconds is recorded. In total, three 15-s test trials were performed, with 45 s rest between each trial.

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Supine moving apprehension test (SMAT) OTHER

The beginning position of the participant is lying in a supine position while holding the weight just over their chest. Participants move their shoulder to 135° of abduction with the elbow extended, then returning to the starting position, and immediately move their shoulder to 180° of abduction with the elbow fully extended and finally return to the starting position. This cycle is repeated as much as possible for 1 minute.

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Physical performance test - Posterior shoulder endurance test (PSET) OTHER

The participant is positioned prone, with the test shoulder off the table and the arm in 90° of horizontal abduction, the point at which the participant is to hold the arm as long as possible until fatigue. The participant holds a weight equal to 2% of his body weight (rounded to the nearest 0.5 kg).

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Patient-reported outcome measure - The Shoulder Instability-Return to Sport after Injury (SIRSI) OTHER

Psycho-social questionnaire assessing the psychological readiness of athletes to return to sport following traumatic shoulder instability and conservative or surgical management. The SIRSI includes 12 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 12 responses then determined in relation to 100 to obtain a percentage. High scores correspond to a positive psychological response.

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Patient-reported outcome measure - Numeric Pain Rating Scale (NPRS) OTHER

Patient's shoulder pain will be measured using an 11-point NRS, with a minimum value of zero ("no pain") and a maximum score of 10 ("the worst pain possible")

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Modified Tampa-Scale of Kinesiophobia for Anterior Shoulder Instability (TSK-SI) OTHER

modified Tampa Scale of Kinesiophobia (TSK) to make it suitable for application in patients with anterior shoulder instability. The TSK-SI contains 18 items and the total score can range from 18 to 72, with 18 being the "best" score (no fear of movement/kinesiophobia) and 72 being the "worst" score (severe fear of movement/kinesiophobia)

Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Other upper limb pathologies/ associated injuries: e.g. posterior instability, or rotator cuff tear,...
• Being pregnant
• No intention to return to pre-injury sport

Sponsors & Collaborators

• University Ghent: lead
• AZ Monica Campus Antwerpen: collaborator

Study Sites (2)

AZ Monica, Deurne - Orthopedie

Antwerp, Belgium

RECRUITING

Department of rehabilitation sciences, Ghent university

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation; Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Ann Cools

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Stubbe

CONTACT

+32 9 332 26 33; jasper.stubbe@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

BE (2)