RecruitingNot Applicable

Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study

Cyprus, Turkey (Türkiye)150 participantsStarted 2026-07-24

Plain-language summary

Ankle fractures are common injuries that can affect a patient's mobility, mood, sleep, and everyday life for months. The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is an English-language patient-reported outcome measure developed in Australia to capture this broader rehabilitation experience. No validated Turkish version of A-FORM currently exists. This prospective multi-centre observational study aims to translate the A-FORM into Turkish (A-FORM-TR), culturally adapt it for use in Turkish-speaking patients, and evaluate its psychometric properties. The investigators will recruit 150 adults with a unilateral ankle fracture, treated either surgically or conservatively, from three orthopedic centres in Turkiye and the Turkish Republic of Northern Cyprus. Participants complete the A-FORM-TR together with two established comparator questionnaires (AOFAS Ankle-Hindfoot Score and the Turkish Olerud-Molander Ankle Score). A subset of approximately 50 participants is re-administered the A-FORM-TR after 7 to 14 days to assess test-retest reliability, with a Global Rating of Change item identifying clinically stable patients. Analyses include classical test theory, confirmatory factor analysis, and Rasch measurement analysis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * Radiographically confirmed unilateral ankle fracture (Weber A, B, or C) * Either surgical (open reduction and internal fixation) or conservative (cast, walker boot, or functional brace) treatment completed * Currently in the rehabilitation phase, 3 weeks to 12 months post-injury * Native Turkish speaker, able to read and self-complete a questionnaire * Able and willing to provide written informed consent Exclusion Criteria: * Bilateral ankle fracture * Previous ipsilateral ankle fracture or any prior orthopedic surgery on the same ankle * Pathological fracture (tumour, metastasis, or other underlying bone pathology) * Concurrent significant ipsilateral lower-limb injury (for example pilon fracture, ipsilateral tibial or fibular shaft fracture, ipsilateral femoral or tibial plateau fracture) * Polytrauma (significant head, spine, abdominal, or contralateral lower-limb injury affecting function) * Cognitive or psychiatric impairment precluding self-completion of the questionnaire * Insufficient Turkish literacy * Inability to attend a follow-up visit for the test-retest assessment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Internal consistency of the A-FORM-TR

Timeframe: At the single study visit (baseline administration)

Test-retest reliability of the A-FORM-TR

Timeframe: 7 to 14 days between the two administrations

Trial details

NCT IDNCT07620015

SponsorUtku Gürhan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04

Contact for this trial

Utku Gurhan, MD

+90 539 112 6898 utkugrhn@gmail.com

View on ClinicalTrials.gov More Ankle Fractures trials