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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03661944
Other study ID # 201807118RINB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2018
Est. completion date January 31, 2020

Study information

Verified date August 2018
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
functional performance test
Functional performance test is to test the ability of the athletes in functional movements

Locations

Country Name City State
Taiwan Institute of Physical Therapy, College of Medicine, National Taiwan University Taipei city

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary FMS functional movement screen 10 minutes
Primary YBTUQ y-balance test upper quarter 10 minutes
Primary USSP unilateral seated shot put test minutes
Primary CKCUEST closed kinetic chain upper extremity stability test 5 minutes
Primary TPUT timed push up test 5 minutes
Secondary shoulder range of motion shoulder flexion, extension, abduction, external and internal rotation 10 minutes
Secondary shoulder muscle strength shoulder flexion, abduction, external and internal rotation 15 minutes
Secondary Disability of Arm, Shoulder and Hand questionnaire 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
Secondary KJOC questionnaire 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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