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

NCT07620015 | Not Yet Recruiting

• 1 other identifier: AFORM-TR-2026
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Ankle Fractures; Ankle Injuries

Keywords

patient-reported outcome measure; PROM; cross-cultural adaptation; psychometric validation; ankle fracture; rehabilitation; Rasch analysis; Turkish

Outcome Measures

Primary Outcomes (2)

• Internal consistency of the A-FORM-TR

  Cronbach's alpha coefficient calculated across all scored items of the A-FORM-TR. Target greater than or equal to 0.80.

  At the single study visit (baseline administration)

• Test-retest reliability of the A-FORM-TR

  Intraclass correlation coefficient (two-way mixed effects, absolute agreement, single measures) calculated for the A-FORM-TR Summary Score, restricted to patients reporting clinical stability (no change) on a Global Rating of Change item between the two administrations. Target greater than or equal to 0.90.

  7 to 14 days between the two administrations

Secondary Outcomes (6)

• Rasch model fit of the A-FORM-TR

  At the single study visit (baseline administration)

• Structural validity by confirmatory factor analysis

  At the single study visit (baseline administration)

• Construct validity assessed by a priori hypothesis testing

  At the single study visit (baseline administration)

• Content validity of the A-FORM-TR

  Pre-testing phase, prior to field testing

• Distribution properties: floor and ceiling effects

  At the single study visit (baseline administration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to the orthopedic outpatient clinics of three participating hospitals (University of Kyrenia, Dr. Suat Gunsel Hospital, Turkish Republic of Northern Cyprus; Ankara Bilkent City Hospital, Turkiye; Near East University Hospital, Turkish Republic of Northern Cyprus) for follow-up of a unilateral ankle fracture in the rehabilitation phase 3 weeks to 12 months post-injury, treated either surgically or conservatively.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Utku Gürhan: lead

Study Sites (3)

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

Kyrenia, Cyprus

Location

Near East University Hospital - Department of Orthopaedics and Traumatology

Nicosia, Cyprus

Location

Ankara Bilkent City Hospital - Department of Orthopaedics and Traumatology

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• McPhail SM, Williams CM, Schuetz M, Baxter B, Tonks P, Haines TP. Development and validation of the ankle fracture outcome of rehabilitation measure (A-FORM). J Orthop Sports Phys Ther. 2014 Jul;44(7):488-99, B1-2. doi: 10.2519/jospt.2014.4980. Epub 2014 May 22.

  PMID: 24853921 BACKGROUND

• Cruchinho P, Lopez-Franco MD, Capelas ML, Almeida S, Bennett PM, Miranda da Silva M, Teixeira G, Nunes E, Lucas P, Gaspar F; Handovers4SafeCare. Translation, Cross-Cultural Adaptation, and Validation of Measurement Instruments: A Practical Guideline for Novice Researchers. J Multidiscip Healthc. 2024 May 31;17:2701-2728. doi: 10.2147/JMDH.S419714. eCollection 2024.

  PMID: 38840704 BACKGROUND

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 BACKGROUND

• Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.

  PMID: 20169472 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Utku Gurhan, MD

  University of Kyrenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Utku Gurhan, MD

CONTACT

+90 539 112 6898; utkugrhn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedics and Traumatology

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CY (2); TU (1)