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RECRUITING
NCT07620015

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

Sponsor: Utku Gürhan

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-07-24

Completion Date

2027-07

Last Updated

2026-07-27

Healthy Volunteers

No

Locations (3)

University of Kyrenia, Dr. Suat Gunsel Hospital - Department of Orthopaedics and Traumatology

Kyrenia, Cyprus

Near East University Hospital - Department of Orthopaedics and Traumatology

Nicosia, Cyprus

Ankara Bilkent City Hospital - Department of Orthopaedics and Traumatology

Ankara, Turkey (Türkiye)