Return to SportVAL_PPT_PNCT07115225
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
A study testing Analytical test - Shoulder Range of Motion (ROM), Analytical test - Shoulder Strength and Modified-Athletic Shoulder Test (M-AST) in people with Return to Sport and Shoulder Dislocation or Subluxation, run by University Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Return to Sport, Shoulder Dislocation or Subluxation
- What is being tested?
- Analytical test - Shoulder Range of Motion (ROM), Analytical test - Shoulder Strength and Modified-Athletic Shoulder Test (M-AST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Jul 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Other upper limb pathologies/ associated injuries: e.g. posterior instability, or rotator cuff tear,...
- Being pregnant
- No intention to return to pre-injury sport
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
AZ Monica, Deurne - Orthopedie
Antwerp
- Recruiting
Department of rehabilitation sciences, Ghent university
Ghent, 9000
Jasper Stubbe, 09 332 26 33, jasper.stubbe@ugent.be
About this study
Official title: Predictive Validity of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation: a Prospective Study
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:
Read more
- 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.
Read the 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).
- Being tested
- Analytical test - Shoulder Range of Motion (ROM), Analytical test - Shoulder Strength, Modified-Athletic Shoulder Test (M-AST), Physical performance test - Unilateral Seated Shot-Put Test (USSPT), Physical performance test - modified-Closed Kinetic Chain Upper Extremity Stability Test (m-CKCUEST)
- Medical subject headings
- Shoulder Dislocation, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Analytical test - Shoulder StrengthOther
Shoulder external rotation and internal rotation measured with a hand held dynanometer in supine lying
Modified-Athletic Shoulder Test (M-AST)Other
Shoulder strength in the antero-posterior plane measured with a hand held dynanometer in prone lying
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.
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.
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.
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).
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.
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")
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: pre-operatively; in return to sport phase; 3 months, 6 months, 9 months, 12 months post-return to sport
Secondary outcomes (1)
Re-injury
The questionnaire will capture re-injuries and subsequent injuries within 12 months after return to sport
Measured: 3 months, 6 months, 9 months, 12 months post-return to sport
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start3 Jul 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Return to SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Monica Campus Antwerpen
- Responsible party
- Sponsor
- Investigators
- Ann Cools, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115225
- Sponsor's protocol ID
- ONZ-2024-0629
- Acronym
- VAL_PPT_P
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Validity of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation: a Prospective Study
- ClinicalTrials.gov ID
- NCT07115225
- Acronym / sponsor ID
- VAL_PPT_P / ONZ-2024-0629
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- AZ Monica Campus Antwerpen
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) | Experimental | 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)Patients who underwent shoulder stabilization surgery (Latarjet or Bankart procedure) between the ages of 16 and 55 years old |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Other upper limb pathologies/ associated injuries: e.g. posterior instability, or rotator cuff tear,...
- Being pregnant
- No intention to return to pre-injury sport
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analytical test - Shoulder Range of Motion (ROM)Passive external rotation in supine position with arm in 90° abduction - passive internal rotation in supine position with arm in 90° abduction. | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Analytical test - Shoulder StrengthShoulder external rotation and internal rotation measured with a hand held dynanometer in supine lying | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Modified-Athletic Shoulder Test (M-AST)Shoulder strength in the antero-posterior plane measured with a hand held dynanometer in prone lying | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Physical performance test - Unilateral Seated Shot-Put Test (USSPT)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. | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Physical performance test - modified-Closed Kinetic Chain Upper Extremity Stability Test (m-CKCUEST)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. | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Supine moving apprehension test (SMAT)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. | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Physical performance test - Posterior shoulder endurance test (PSET)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). | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Patient-reported outcome measure - The Shoulder Instability-Return to Sport after Injury (SIRSI)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. | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Patient-reported outcome measure - Numeric Pain Rating Scale (NPRS)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") | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
| Modified Tampa-Scale of Kinesiophobia for Anterior Shoulder Instability (TSK-SI)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) | Other | Patients after shoulder stabilization procedure (Latarjet or Bankart procedure) |
Primary outcome
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).
1 secondary outcome
Re-injury
Time frame: 3 months, 6 months, 9 months, 12 months post-return to sport
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Cools principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analytical test - Shoulder Range of Motion (ROM), Analytical test - Shoulder Strength and Modified-Athletic Shoulder Test (M-AST) in people with Return to Sport and Shoulder Dislocation or Subluxation, run by University Ghent at 2 sites in Belgium.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasper Stubbe (+32 9 332 26 33, jasper.stubbe@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Patient Outcome for Return to Sports (SPORTS) score (time frame: 3 months, 6 months, 9 months, 12 months post-return to sport). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.