Sports Physical TherapyNCT03661944
Functional Performance Assessments in Overhead Athletes With Shoulder Injury
An observational study of Sports Physical Therapy and Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Sports Physical Therapy, Rehabilitation
- What is being tested?
- functional performance test
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2018to 31 Jan 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Overhead athletes with shoulder injury
Who may be able to join
- 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
Who cannot join
- Other severe orthopedic injuries in upper extremity, lower extremity and spine within 1 year
- has no intention to return to play
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 110
About this study
Official title: 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.
- Conditions
- Sports Physical Therapy, Rehabilitation
- Being tested
- functional performance test
- Keywords
- sports, physical therapy, return to play, overhead athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional performance testDiagnostic test
Functional performance test is to test the ability of the athletes in functional movements
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic group | There is no intervention in this group, only functional assessments and general physical examinations will be done Receives: Diagnostic Test: functional performance test | |
| Healthy control group | There is no intervention in this group, only functional assessments and general physical examinations will be done Receives: Diagnostic Test: functional performance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMS
functional movement screen
Measured: 10 minutes
YBTUQ
y-balance test upper quarter
Measured: 10 minutes
USSP
unilateral seated shot put test
Measured: minutes
CKCUEST
closed kinetic chain upper extremity stability test
Measured: 5 minutes
TPUT
timed push up test
Measured: 5 minutes
Secondary outcomes (4)
shoulder range of motion
shoulder flexion, extension, abduction, external and internal rotation
Measured: 10 minutes
shoulder muscle strength
shoulder flexion, abduction, external and internal rotation
Measured: 15 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start25 Sep 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Hung Chao, Principal investigator, Institution of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661944
- Sponsor's protocol ID
- 201807118RINB
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Functional Performance Assessments in Overhead Athletes With Shoulder Injury Assess the Ability of Return to Play (RTP)?
- ClinicalTrials.gov ID
- NCT03661944
- Acronym / sponsor ID
- 201807118RINB
- Conditions
- Sports Physical Therapy, Rehabilitation
- Keywords
- sports, physical therapy, return to play, overhead athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 7 Sep 2018 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic group | – | Diagnostic Test: functional performance testThere is no intervention in this group, only functional assessments and general physical examinations will be done |
| Healthy control group | – | Diagnostic Test: functional performance testThere is no intervention in this group, only functional assessments and general physical examinations will be done |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Overhead athletes with shoulder injury
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Other severe orthopedic injuries in upper extremity, lower extremity and spine within 1 year
- has no intention to return to play
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 |
|---|---|---|
| functional performance testFunctional performance test is to test the ability of the athletes in functional movements | Diagnostic test | Healthy control group, Symptomatic group |
Primary outcome
FMS
Time frame: 10 minutes
functional movement screen
YBTUQ
Time frame: 10 minutes
y-balance test upper quarter
USSP
Time frame: minutes
unilateral seated shot put test
CKCUEST
Time frame: 5 minutes
closed kinetic chain upper extremity stability test
TPUT
Time frame: 5 minutes
timed push up test
4 secondary outcomes
shoulder range of motion
Time frame: 10 minutes
shoulder muscle strength
Time frame: 15 minutes
Disability of Arm, Shoulder and Hand questionnaire
Time frame: 10 minutes
KJOC questionnaire
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yuan-Hung Chao principal investigator
Institution of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Physical Therapy and Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMS (time frame: 10 minutes). The study lists 5 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 26 Mar 2020.