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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-55
SponsorUniversity Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Analytical test - Shoulder Range of Motion (ROM)

    Other intervention

    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 Strength

    Other intervention

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

  • Modified-Athletic Shoulder Test (M-AST)

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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 intervention

    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)

Treatment groups

129 Participants
are divided into 1 treatment group
Group A: Patients after shoulder stabilization procedure (Latarjet or Bankart procedure)Experimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months, 6 months, 9 months, 12 months post-return to sport
2

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).

Time frame
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

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

Other outcomes

Sponsors and contacts

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University Ghent

Lead sponsor

AZ Monica Campus Antwerpen

Collaborator