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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Injuries; Ankle Fractures

Detailed Description

Background and Rationale: Ankle fractures are among the most common lower-limb injuries in orthopedic practice. Patient-reported recovery, including physical function, sleep, mood, and social participation, is not adequately captured by traditional clinician-based outcome measures such as the AOFAS Ankle-Hindfoot Score or the Olerud-Molander Ankle Score. The A-FORM, developed by McPhail et al. (2014), is a 15-item, Rasch-calibrated patient-reported outcome measure designed specifically to evaluate the rehabilitation experience after ankle fracture. No validated Turkish-language version currently exists.

Methodological Framework: The study follows the eight-stage cross-cultural adaptation and validation protocol described by Cruchinho et al. (2024), which incorporates the recommendations of Beaton et al. (2000) and the COSMIN framework (Mokkink et al., 2010). Written permission to translate and use the instrument has been granted by Prof. Steven McPhail (Queensland University of Technology).

Translation and Adaptation: Forward translation is carried out by two independent bilingual translators (one faculty member from the Department of English Language and Literature, providing linguistic expertise; one bilingual orthopedic surgeon, providing clinical content expertise). A reconciliation committee produces a synthesised Turkish version, which is then back-translated by two independent translators blinded to the original. A harmonisation expert committee compares the source, forward, and back versions for semantic, idiomatic, experiential, and conceptual equivalence. The harmonised pre-test version is evaluated through cognitive debriefing interviews with 10 to 15 ankle-fracture patients before field testing.

Field Testing: In the field testing phase, 150 adult patients with a radiographically confirmed unilateral ankle fracture (Weber A, B, or C; treated surgically by open reduction and internal fixation or conservatively with cast, walker boot, or functional brace) are enrolled across three orthopedic centres. Patients between 3 weeks and 12 months post-injury are eligible. The A-FORM-TR is administered together with the AOFAS Ankle-Hindfoot Score and the OMAS-TR. A sub-cohort of approximately 50 patients is re-administered the A-FORM-TR at 7 to 14 days, with a Global Rating of Change item used to identify clinically stable patients for the test-retest reliability analysis.

Statistical Analysis Plan: Developed in consultation with the institutional biostatistics team. Internal consistency is assessed by Cronbach's alpha (target greater than or equal to 0.80). Test-retest reliability is assessed by the intraclass correlation coefficient on stable patients (target greater than or equal to 0.90). Structural validity is assessed by confirmatory factor analysis against the a priori structure established by the original developers. Rasch measurement analysis examines item fit, threshold ordering, person separation reliability, person-item targeting, local independence, unidimensionality, and differential item functioning by sex, age group, treatment modality, recruiting centre, and time since injury. Construct validity is assessed via pre-specified hypotheses about correlation patterns with the AOFAS and OMAS-TR. Content validity is assessed via item-level and scale-level Content Validity Index and the Kappa coefficient from the expert committee. Floor and ceiling effects are reported. Responsiveness is not formally evaluated in this initial validation study and is reserved for a planned subsequent longitudinal study. Analyses use SPSS version 26 or later and R (lavaan, psych, eRm, and TAM packages).

Ethics and Registration: Ethics approval is sought from the Girne University Clinical Research Ethics Committee. An institutional permission letter is obtained from Ankara Bilkent City Hospital. Data are handled in accordance with the Turkish Personal Data Protection Law (KVKK No. 6698): pseudonymised, securely stored, and retained for a maximum of 5 years post-publication.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Utku Gurhan, MD; Phone Number: +90 539 112 6898; Email: utkugrhn@gmail.com

Study Locations

• Cyprus
  • Kyrenia, Cyprus
    • University of Kyrenia, Dr. Suat Gunsel Hospital - Department of Orthopaedics and Traumatology
    • Contact: Utku Gurhan, MD; Email: utkugrhn@gmail.com
    • Principal Investigator: Utku Gurhan, MD
  • Nicosia, Cyprus
    • Near East University Hospital - Department of Orthopaedics and Traumatology
    • Sub-Investigator: Enes Sari, MD
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Ankara Bilkent City Hospital - Department of Orthopaedics and Traumatology
    • Contact: Yakup Kahve, MD; Email: ykahve@hotmail.com
    • Sub-Investigator: Yakup Kahve, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural validity by confirmatory factor analysis	Confirmatory factor analysis testing the a priori factor structure established by McPhail et al. (2014). Model fit assessed by CFI and TLI (target greater than or equal to 0.95), RMSEA (target less than or equal to 0.08), and SRMR (target less than or equal to 0.08).	At the single study visit (baseline administration)
Rasch model fit of the A-FORM-TR	Rasch measurement analysis including item fit (infit and outfit mean-square 0.5 to 1.5), category threshold ordering, person separation reliability (target greater than or equal to 2.0), local independence (residual correlations less than 0.30), unidimensionality (residual principal component analysis first contrast less than 2.0), and differential item functioning by sex, age group, treatment modality, centre, and time since injury.	At the single study visit (baseline administration)
Construct validity assessed by a priori hypothesis testing	Pearson or Spearman correlations between the A-FORM-TR Summary Score and the AOFAS Ankle-Hindfoot Score and OMAS-TR. Pre-specified hypotheses: H1, strong positive correlation between A-FORM-TR and OMAS-TR (r greater than or equal to 0.60); H2, moderate positive correlation between A-FORM-TR and AOFAS (r between 0.40 and 0.60); H3, the psychosocial items of the A-FORM-TR correlate more weakly with the AOFAS than the physical-function items. Construct validity is considered supported if at least 75 percent of the a priori hypotheses are confirmed.	At the single study visit (baseline administration)
Content validity of the A-FORM-TR	Item-level and scale-level Content Validity Index and the Kappa coefficient of agreement derived from the expert committee evaluation conducted in the pre-testing phase.	Pre-testing phase, prior to field testing
Distribution properties: floor and ceiling effects	Percentage of participants scoring at the floor (lowest possible score) and ceiling (highest possible score) of the A-FORM-TR Summary Score. Effects are considered acceptable if less than 15 percent at either extreme.	At the single study visit (baseline administration)

Collaborators and Investigators

• Sponsor: Utku Gürhan
• Investigators: Principal Investigator: Utku Gurhan, MD, University of Kyrenia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; PROM; psychometric validation; Turkish; ankle fracture; Rasch analysis; patient-reported outcome measure; cross-cultural adaptation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: AFORM-TR-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level data will be made available upon reasonable request to the corresponding author after publication, subject to institutional and ethics-committee approval. Aggregated summary tables will accompany the published manuscript as supplementary material.
• IPD Sharing Time Frame: Beginning 6 months after manuscript publication, with no specified end date.
• IPD Sharing Access Criteria: Reasonable request for academic research purposes; a data use agreement to be signed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No