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NCT07620015
Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study
Conditions: Ankle Fractures, Ankle Injuries
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Utku Gürhan
Location: University of Kyrenia, Dr. Suat Gunsel Hospital - Department of Orthopaedics and Traumatology Kyrenia
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07620015). StuddyBuddy aggregates publicly available trial information.