- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661944
Functional Performance Assessments in Overhead Athletes With Shoulder Injury
Can Functional Performance Assessments in Overhead Athletes With Shoulder Injury Assess the Ability of Return to Play (RTP)?
Background & Purpose: Shoulder injuries are commonly seen in overhead athletes due to the mechanism of the repetitive and high velocity movement. While the injury usually cost the lost of time in playing, making the decision of the time to return to play (RTP) is a critical issue that should be standardized and objective. However, current studies showed that the decision making of RTP is so complicated that there's lack of objective measurements especially for upper extremity injuries. So, investigating the usage of convenient and valid tools, functional performance assessments for assessing the ability to RTP is the main objective of this study.
Objective: There are 2 objectives for this study: (1) to investigate the difference between RTP group and non-RTP in overhead athletes with shoulder injury; (2) to investigate the responsiveness of the functional performance assessment in return to play for overhead athletes with shoulder injury. Methods: Overhead athletes with shoulder injury or surgery which leads to temporary leaving to the sport within will be recruited in this study. The shoulder joint range of motion (flexion, extension, external/internal rotation, and abduction), shoulder muscle strength (flexors, abductors and external/internal rotators), patient-reported outcome (KJOC and DASH questionnaire) and functional performance assessments (FMS, YBT-UQ, CKCUEST, USSP and TPUT) will be assessed at 6 months after the athlete was injured or received surgery, and at the time point if the athletes successfully complete at least one formal game or practice game (RTP group). If the athlete doesn't return within 12 months after injury or surgery, the assess will be done at the 12th month after injury or surgery. Significance and Contribution: This study is going to provide an objective measurement value of functional performance assessment in injured overhead athletes, determining whether the strength, endurance or power of the upper extremity is good enough to return to the sport that the athlete played before this injury. The result is also expected to have significant contribution in the area of sports medicine in return to play especially in overhead athletes, which has limited evidence providing specific criteria and objective measurement value previously.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Taipei city, Taiwan, 110
- Institute of Physical Therapy, College of Medicine, National Taiwan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- overhead athletes diagnosed with shoulder injury within 6 months and can't play the current sports
- accepting the routine rehabilitation
- have the intention to go back to current sports
Exclusion Criteria:
- Other severe orthopedic injuries in upper extremity, lower extremity and spine within 1 year
- has no intention to return to play
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Symptomatic group
There is no intervention in this group, only functional assessments and general physical examinations will be done
|
Functional performance test is to test the ability of the athletes in functional movements
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Healthy control group
There is no intervention in this group, only functional assessments and general physical examinations will be done
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Functional performance test is to test the ability of the athletes in functional movements
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FMS
Time Frame: 10 minutes
|
functional movement screen
|
10 minutes
|
YBTUQ
Time Frame: 10 minutes
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y-balance test upper quarter
|
10 minutes
|
USSP
Time Frame: minutes
|
unilateral seated shot put test
|
minutes
|
CKCUEST
Time Frame: 5 minutes
|
closed kinetic chain upper extremity stability test
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5 minutes
|
TPUT
Time Frame: 5 minutes
|
timed push up test
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
shoulder range of motion
Time Frame: 10 minutes
|
shoulder flexion, extension, abduction, external and internal rotation
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10 minutes
|
shoulder muscle strength
Time Frame: 15 minutes
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shoulder flexion, abduction, external and internal rotation
|
15 minutes
|
Disability of Arm, Shoulder and Hand questionnaire
Time Frame: 10 minutes
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patient reported outcome about the functional status of the shoulder The questionnaire is divided into 4 parts, the first part assesses the disability in daily activities, the second part assesses the severity of the symptom, the third and fourth part assesses the disability in working and playing sports or music instruments. The scale is from 1 to 5, which higher points indicates greater disability. First and second part will be sum up and get the total score, which higher score indicates greater disability in arm, shoulder or hand region. The third and fourth part will be assessed independently, and the score as well as higher scores indicates higher degree of disability in arm, shoulder, and hand region. |
10 minutes
|
KJOC questionnaire
Time Frame: 10 minutes
|
patient reported outcome about the functional status of the shoulder This questionnaire contains 10 different items, which are about the performance during overhead sports competition.
Each item score ranges from 0 to 10, which higher scores indicate better performance or less change or influence in their performance and each item will be sum up to get the total score.
Therefore, the total score ranges from 0 to 100, and the higher the score, the better the functional status they were.
|
10 minutes
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Collaborators and Investigators
Investigators
- Principal Investigator: Yuan-Hung Chao, Institution of Physical Therapy, National Taiwan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201807118RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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