RecruitingNCT07620015

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

Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Prospective Observational Study

Sponsor

Utku Gürhan

Enrollment

150 participants

Start Date

Jul 24, 2026

Study Type

OBSERVATIONAL

Conditions

Ankle injuries Ankle Fractures

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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