Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUtku Gürhan
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
At the single study visit (baseline administration)2
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.
Time frame
7 to 14 days between the two administrationsSecondary outcomes
1
Rasch model fit of the A-FORM-TR
Rasch measurement analysis serves as the primary framework for evaluating dimensionality and measurement properties of the A-FORM-TR. Examined: 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. A priori decision rules: items showing substantive misfit will be reviewed for rescoring or removal; disordered thresholds will trigger response category collapsing and re-analysis; items showing significant DIF will be split or removed and the analysis re-run on the modified scale.
Time frame
At the single study visit (baseline administration)2
Structural validity by confirmatory factor analysis
Confirmatory factor analysis testing the prespecified single-factor (unidimensional) structure established in the original A-FORM development by McPhail et al. (2014). CFA serves as a complementary structural check from a latent-variable perspective alongside the primary Rasch analysis. 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).
Time frame
At the single study visit (baseline administration)3
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.
Time frame
At the single study visit (baseline administration)4
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.
Time frame
Pre-testing phase, prior to field testingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Utku Gürhan
Lead sponsor
University of Kyrenia
Sponsor institution
Source ClinicalTrials.gov