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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06153121
Other study ID # ONZ-2023-0320
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2023
Est. completion date November 2029

Study information

Verified date November 2023
Source University Ghent
Contact Jasper Stubbe
Phone 09 332 26 33
Email jasper.stubbe@hotmail.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This project comprises two studies; a cross-sectional study and a prospective study. 1. The cross-sectional study aims to develop and validate a new sport-specific test battery (PROMs, analytical and physical performance tests) in healthy tennis players and swimmers.The construct validity of this upper extremity test battery will be examined through two different methods. 1. Firstly, the performance on the test battery will be correlated to sport performance (sprint time at 100m freestyle in swimming and serve speed/accuracy in tennis) 2. Secondly, the correlation between test battery performance and upper limb/trunk kinematics in a tennis serve (measured via inertial measurement units (IMUs)) will be examined. 2. In the prospective study, the predictive validity of the test battery will be evaluated. Healthy swimmers and tennis players will be tested at baseline using the same test battery as mentioned above. However, the test battery will adapted based of the results of the cross-sectional study. The athletes will be followed for one year and new injuries will be recorded via a weekly questionnaire. Performance on the test battery will be associated with the incidence of musculoskeletal injuries.


Description:

Upper extremity physical performance tests (PPTs) of the upper limb are physically challenging tests and are supposed to be sport-specific and mimic the sport specific movements or load. Currently, there is no strong evidence for the validity of many upper extremity physical performance tests, although these tests are widely used in the return-to-sport phase after upper limb injuries. There is a clear need for a validating test physical performance tests. Validation of these PPTs is possible in several ways, e.g. correlation to an analytical construct such as strength. However, it is important that these tests are sport-specific. For this reason, the correlation between physical performance tests on the one hand and sports performance (in swimming and tennis) and upper limb kinematics during a tennis serve on the other hand will be evaluated in this study. However, a single PPT is unlikely to correlate strongly with sport performance or tennis serve kinematics, as previous studies have shown a weak to moderate association when a single PPT was correlated with sport performance or another construct. Therefore, a cluster of tests will be assessed; four PPTs per sport and three analytical tests measuring strength and mobility of shoulder and hand, since these are the cornerstone of testing protocols in sports rehabilitation. In addition, patient-reported outcome measures (PROMs), questionnaires that measure physical and psychosocial factors, are becoming increasingly important in sports. Recent studies show that these factors influence sports performance and rehabilitation outcomes. Therefore, these questionnaires can be very useful in the return-to-sport phase and injury risk screening. The PROMs that will be used in this study are the following: Kerlan-Jobe Orthopedic Clinic Shoulder and Elbow Score (KJOC-SES), Competitive State Anxiety Inventory-2 (CSAI-2) and the general self-efficacy scale. To conclude, the test battery consists of PPTs, analytical tests (strength and mobility) and PROMs.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 2029
Est. primary completion date November 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 35 Years
Eligibility Inclusion Criteria: - In good general health - Play tennis or swim competitively, at least 3 hours per week (training + competition) Exclusion Criteria: - History of shoulder dislocation in dominant and/or nondominant shoulder - History of upper extremity surgery - At the moment of participation, participants should not report a substantial injury (defined by the Oslo Sports Trauma Research Centre questionnaire on health problems) in the past two months. A substantial injury is defined as a moderate or severe reduction in training volume or reduction in sports performance or complete inability to participate in sport as substantial injuries and illnesses. - Neurological symptoms in any extremity - Suffering from a systemic disease (such as diabetes, lupus, arthrosis,.. )

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Department of rehabilitation sciences Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical performance test - Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) The test is performed in a pushup position with the hands placed 91.4 cm 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. Baseline
Primary Physical performance test - modified Closed Kinetic Chain Upper Extremity Stability Test (m-CKCUEST) The test is performed in a pushup 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. Baseline
Primary Physical performance test - Seated Seated Single Arm Shot Put Test (SSASPT) Set up requires that the subject is placed in a seated position with their back against the wall, and a 2kg medicine ball held in a shot put position. When ready, the subject will perform a shot put motion to project the medicine ball as far as possible. The average of three trials is recorded for each arm. Baseline
Primary Physical performance test - Upper Limb Rotation Test (ULRT) Participants starts in a modified (on elbows) push-up position. Participants are positioned next to a wall in order to allow the shoulder, the elbow epicondyle, the greater trochanter and the lateral malleolus of the ankle to touch the wall. Participants are asked to perform a trunk rotation, coupled with an external rotation of the shoulder in a 90°-90° position (90° abduction, 90° external rotation) touching the tape placed vertically on the wall as quickly as possible for 15 s. Finally, three 15-s test trials were performed, with 45 s rest between each trial. Baseline
Primary Physical performance test - Shoulder endurance test (SET) Participants were instructed to stand up straight with their back against a wall. The tested arm was placed in a 90°forward flexion holding a 1-m long thera-band® fixed at shoulder height on a graduated stick. Participants were asked to pull the thera-band® from the starting position 90°forward flexion-to a 90° external rotation and 90° abduction (90°90°position) at an alternated cadence given by a metronome. Males are asked to pull a green thera-band (2.1 kg) and females a red thera-band (1.7 kg). Repetitions are performed until the participant is fatigued. Baseline
Primary Physical performance test - Posterior shoulder endurance test (PSET) The participant is positioned prone, with the test shoulder off the table and the arm perpendicular to the floor. A bar on a stick is adjusted for each patient and fixed at the point that the participant's shoulder reaches 90° of horizontal abduction, the point at which the participant was to hold the arm at the top of the arc of motion for 1 second. The participant held a weight equal to 2% of his body weight (rounded to the nearest 0.5 kg). Starting with the arm perpendicular to the floor, the participant horizontally abducted his arm to 90 degrees at a cadence of 30 beats per minute. Repetitions are performed until the participant is fatigued. Baseline
Secondary Analytical test - Shoulder Strength shoulder external rotation and internal rotation measured with a hand held dynanometer Baseline
Secondary Analytical test - Hand Grip Strength Hand grip strength measured with a JAMAR Hand Dynamometer Baseline
Secondary 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. Baseline
Secondary PROM - Kerlan-Jobe Orthopedic Clinic Shoulder and Elbow Score (KJOC-SES) The KJOC-SES survey is composed of ten 10-point questions to evaluate specifically the performance of overhead athletes, with the highest performance score of 100. Baseline
Secondary PROM - Competitive State Anxiety Inventory-2 (CSAI-2) The Competitive State Anxiety Inventory scale contains 27 items. It a psychometric scale that asks the volunteer to rate, on a 4-point Likert scale, their coping skills for sports performance. Baseline
Secondary PROM - General elf-efficacy scale (GSES). The GSES measures (10 statements) how a person deals with stressors/difficult situations in life. The scale is about a person's self-confidence that his or her actions are responsible for successful outcomes or, in other words, that one has control over challenging demands imposed by the environment. Baseline
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