Shoulder Injuries and DisordersNCT07893899
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
An observational study of Shoulder Injuries and Disorders and Elbow Injuries and Disorders, run by Elif Turgut at 1 site in Turkey (Türkiye).
Trial summary
The Functional Arm Scale for Throwers (FAST) is a patient-reported outcome measure that assesses upper extremity function in overhead throwing athletes. This methodological study aims to cross-culturally adapt the FAST into Turkish (FAST-TR) and to evaluate its validity and reliability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injuries and Disorders, Elbow Injuries and Disorders, Athletic Injuries
- How many people
- 217 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2026to 21 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Overhead athletes aged 18 years or older who participate in at least one overhead sport at the recreational, amateur, or professional level, including both asymptomatic athletes and athletes with shoulder or elbow problems.
Who may be able to join
- Aged 18 years or older
- Native Turkish speaker
- Participating in at least one overhead sport at the recreational, amateur, or professional level
- Regular participation in sports (at least 6 months per year) for at least the last 3 years
Who cannot join
- Major trauma or shoulder/elbow surgery within the last 6 months
- Being a Paralympic athlete
- Pregnancy
- New injury occurring between the test and retest sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation, Sports Physiotherapy Unit.
Ankara, 06100
About this study
The Functional Arm Scale for Throwers (FAST) is a patient-reported outcome measure that assesses upper extremity function in overhead throwing athletes. This methodological study aims to cross-culturally adapt the FAST into Turkish (FAST-TR) and to evaluate its validity and reliability. The adaptation process follows Beaton's guidelines, including forward translation, synthesis, back translation, expert committee review, and pretesting in 30 athletes. Overhead athletes aged 18 years or older who have regularly participated in at least one overhead sport for at least 3 years complete a demographic and sports information form, the FAST-TR, the Turkish versions of the Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score, and the Quick-DASH. A subgroup of participants completes the FAST-TR again 5 to 7 days later to assess test-retest reliability. Floor and ceiling effects, internal consistency, test-retest reliability, measurement error, construct validity, and known-groups validity between asymptomatic and symptomatic athletes are analyzed.
- Keywords
- Functional Arm Scale for Throwers, Overhead Athletes, Throwing Athletes, Cross-Cultural Adaptation, Validity, Reliability, Patient-Reported Outcome Measure
- Medical subject headings
- Shoulder Injuries, Disease, Elbow Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Overhead Athletes | Overhead athletes without shoulder problem. | |
| Symptomatic Athletes Unable to Continue Sports | Overhead athletes with shoulder problem who are unable to continue participating in their sport. | |
| Symptomatic Athletes Continuing Sports | Overhead athletes with shoulder problem who continue participating in their sport. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Arm Scale for Throwers - Turkish Version (FAST-TR) Score
The FAST is a patient-reported outcome measure consisting of 22 items and a 9-item pitcher/thrower module that assesses upper extremity function in throwing athletes. Total and subscale scores range from 0 to 100, with higher scores indicating greater disability. Internal consistency, test-retest reliability, and validity of the Turkish version will be evaluated.
Measured: Baseline and 5-7 days after baseline
Secondary outcomes (2)
Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score
The KJOC is a 10-item questionnaire assessing shoulder and elbow function in overhead athletes using visual analog scales. Total score ranges from 0 to 100, with higher scores indicating better function. It will be used to evaluate the construct validity of the FAST-TR.
Measured: Baseline
Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Score
The Quick-DASH is an 11-item questionnaire with an optional 4-item sports/performing arts module assessing upper extremity disability. Scores range from 0 to 100, with higher scores indicating greater disability. It will be used to evaluate the construct validity of the FAST-TR.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start18 Oct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder Injuries and DisordersStudies of the same condition, open and under way.
- 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
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elif Turgut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Turgut, Hacettepe University
- Investigators
- Elif Turgut, PhD, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893899
- Sponsor's protocol ID
- FTREK26/17
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent obtained from participants and the ethics committee approval do not cover public sharing of raw data.
Publications
Huxel Bliven KC, Snyder Valier AR, Bay RC, Sauers EL. The Functional Arm Scale for Throwers (FAST)-Part II: Reliability and Validity of an Upper Extremity Region-Specific and Population-Specific Patient-Reported Outcome Scale for Throwing Athletes. Orthop J Sports Med. 2017 Apr 7;5(4):2325967117700019. doi: 10.1177/2325967117700019. eCollection 2017 Apr.
PubMed 28451614Sauers EL, Bay RC, Snyder Valier AR, Ellery T, Huxel Bliven KC. The Functional Arm Scale for Throwers (FAST)-Part I: The Design and Development of an Upper Extremity Region-Specific and Population-Specific Patient-Reported Outcome Scale for Throwing Athletes. Orthop J Sports Med. 2017 Mar 30;5(3):2325967117698455. doi: 10.1177/2325967117698455. eCollection 2017 Mar.
PubMed 28451608
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
- ClinicalTrials.gov ID
- NCT07893899
- Acronym / sponsor ID
- FTREK26/17
- Keywords
- Functional Arm Scale for Throwers, Overhead Athletes, Throwing Athletes, Cross-Cultural Adaptation, Validity, Reliability, Patient-Reported Outcome Measure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- Elif TurgutUniversity, hospital or other
- Study start
- 18 Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
The Functional Arm Scale for Throwers (FAST) is a patient-reported outcome measure that assesses upper extremity function in overhead throwing athletes. This methodological study aims to cross-culturally adapt the FAST into Turkish (FAST-TR) and to evaluate its validity and reliability. The adaptation process follows Beaton's guidelines, including forward translation, synthesis, back translation, expert committee review, and pretesting in 30 athletes. Overhead athletes aged 18 years or older who have regularly participated in at least one overhead sport for at least 3 years complete a demographic and sports information form, the FAST-TR, the Turkish versions of the Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score, and the Quick-DASH. A subgroup of participants completes the FAST-TR again 5 to 7 days later to assess test-retest reliability. Floor and ceiling effects, internal consistency, test-retest reliability, measurement error, construct validity, and known-groups validity between asymptomatic and symptomatic athletes are analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Overhead Athletes | – | –Overhead athletes without shoulder problem. |
| Symptomatic Athletes Unable to Continue Sports | – | –Overhead athletes with shoulder problem who are unable to continue participating in their sport. |
| Symptomatic Athletes Continuing Sports | – | –Overhead athletes with shoulder problem who continue participating in their sport. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Overhead athletes aged 18 years or older who participate in at least one overhead sport at the recreational, amateur, or professional level, including both asymptomatic athletes and athletes with shoulder or elbow problems.
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Native Turkish speaker
- Participating in at least one overhead sport at the recreational, amateur, or professional level
- Regular participation in sports (at least 6 months per year) for at least the last 3 years
Key exclusion criteria (4 listed)
- Major trauma or shoulder/elbow surgery within the last 6 months
- Being a Paralympic athlete
- Pregnancy
- New injury occurring between the test and retest sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Arm Scale for Throwers - Turkish Version (FAST-TR) Score
Time frame: Baseline and 5-7 days after baseline
The FAST is a patient-reported outcome measure consisting of 22 items and a 9-item pitcher/thrower module that assesses upper extremity function in throwing athletes. Total and subscale scores range from 0 to 100, with higher scores indicating greater disability. Internal consistency, test-retest reliability, and validity of the Turkish version will be evaluated.
2 secondary outcomes
Kerlan-Jobe Orthopaedic Clinic (KJOC) Shoulder and Elbow Score
Time frame: Baseline
Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 28451614Huxel Bliven KC, Snyder Valier AR, Bay RC, Sauers EL. The Functional Arm Scale for Throwers (FAST)-Part II: Reliability and Validity of an Upper Extremity Region-Specific and Population-Specific Patient-Reported Outcome Scale for Throwing Athletes. Orthop J Sports Med. 2017 Apr 7;5(4):2325967117700019. doi: 10.1177/2325967117700019. eCollection 2017 Apr.
- Background: PubMed 28451608Sauers EL, Bay RC, Snyder Valier AR, Ellery T, Huxel Bliven KC. The Functional Arm Scale for Throwers (FAST)-Part I: The Design and Development of an Upper Extremity Region-Specific and Population-Specific Patient-Reported Outcome Scale for Throwing Athletes. Orthop J Sports Med. 2017 Mar 30;5(3):2325967117698455. doi: 10.1177/2325967117698455. eCollection 2017 Mar.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent obtained from participants and the ethics committee approval do not cover public sharing of raw data.
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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.
Elif Turgut, PhD, PT principal investigator
Hacettepe 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 Shoulder Injuries and Disorders and Elbow Injuries and Disorders, run by Elif Turgut at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Açelya Çalışkan, PT (+90 5395512657, acelyaacaliskan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Arm Scale for Throwers - Turkish Version (FAST-TR) Score (time frame: Baseline and 5-7 days after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07893899, which also lists 2 linked publications.
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 Oct 2026.