Ankle FracturesA-FORM-TRNCT07620015
Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study
An observational study of Ankle Fractures and Ankle Injuries, run by Utku Gürhan at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures, Ankle Injuries
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Jul 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Cyprus2 sites
University of Kyrenia, Dr. Suat Gunsel Hospital - Department of Orthopaedics and Traumatology
Kyrenia
Near East University Hospital - Department of Orthopaedics and Traumatology
Nicosia
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital - Department of Orthopaedics and Traumatology
Ankara, Ankara, 06800
About this study
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
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.
Read the 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: The analysis plan was locked before any field data were collected; all decision rules are pre-specified. 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, reported with the K-index (greater than or equal to 0.70 acceptable for group-level comparison, greater than or equal to 0.90 desirable for individual-level decisions). Measurement error is evaluated separately from reliability as the standard error of measurement and the smallest detectable change. Rasch measurement analysis is the primary framework and 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; pre-specified decision rules govern the handling of item misfit, disordered thresholds and differential item functioning. Confirmatory factor analysis provides a complementary structural test of the prespecified single-factor model, with exploratory factor analysis run as a supplementary check. Construct validity is assessed via pre-specified hypotheses about correlation patterns with the AOFAS and OMAS-TR, and by known-groups comparison across time-since-injury strata. Criterion validity is assessed in a bilingual sub-study of approximately 30 participants completing both the A-FORM-TR and the original English-language A-FORM in counterbalanced order, with agreement quantified by correlation, intraclass correlation and Bland-Altman analysis. Responsiveness is assessed at 3 months against a Global Rating of Change anchor using the standardised response mean (SRM), effect size and receiver operating characteristic (ROC) analysis, with the minimal important change compared against the smallest detectable change. Cross-cultural measurement invariance is examined against the original English calibration, conditional on the source data available from the instrument developer. 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 examined at the scale level. Missing data are reported per item; the primary analysis is complete-case, with multiple imputation as a sensitivity analysis where item-level missingness exceeds 5 percent.
- Conditions
- Ankle Fractures, Ankle Injuries
- Keywords
- patient-reported outcome measure, PROM, cross-cultural adaptation, psychometric validation, ankle fracture, rehabilitation, Rasch analysis, Turkish
- Medical subject headings
- Ankle Fractures, Ankle Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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. The K-index of agreement is reported alongside the ICC. Thresholds: greater than or equal to 0.70 acceptable for group-level comparison; greater than or equal to 0.90 desirable for individual-level decisions.
Measured: Second administration at day 7 and third administration at day 14 after baseline
Secondary outcomes (10)
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.
Measured: At the single study visit (baseline administration)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the single study visit (baseline administration)
Known-groups validity by time since injury and treatment modality
Known-groups validity assessed by testing whether A-FORM-TR Summary Scores differ across pre-specified clinical subgroups. Pre-specified hypotheses: H4, patients in the 3-week to 3-month post-injury subgroup will score significantly lower (greater impairment) than patients in the 6- to 12-month subgroup; H5, A-FORM-TR Summary Scores will differ between surgically treated and conservatively treated patients (no a priori directional hypothesis). Analyses by independent-samples t-test or Mann-Whitney U as appropriate, with Cohen's d or effect size reporting. Added in response to peer review feedback from the original instrument developer.
Measured: At the single study visit (baseline administration)
Measurement error of the A-FORM-TR
Standard error of measurement (SEM) derived from the test-retest data, and the smallest detectable change (SDC) calculated as 1.96 x square root of 2 x SEM. Bland-Altman plots with limits of agreement are reported. Measurement error is evaluated as a property distinct from reliability, in line with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework.
Measured: Between baseline and the day 14 administration
Responsiveness of the A-FORM-TR
Ability of the A-FORM-TR to detect change over time, assessed against an anchor. Change scores from baseline to 3 months are correlated with a single-item Global Rating of Change (expected r greater than or equal to 0.50). The standardised response mean (SRM) and effect size are computed separately in patients reporting improvement and in those reporting no change (expected SRM greater than or equal to 0.80 versus less than 0.20). Discrimination between improved and stable patients is assessed by receiver operating characteristic (ROC) analysis, with the area under the curve (AUC) expected to be greater than or equal to 0.70. The minimal important change derived from the ROC optimal cut-point is compared against the smallest detectable change.
Measured: Baseline and 3 months
Criterion validity against the original English A-FORM
In a bilingual sub-study of approximately 30 Turkish Cypriot participants who are functionally literate in both Turkish and English, both the A-FORM-TR and the original English-language A-FORM are administered in counterbalanced order with at least 30 minutes between administrations. Agreement between the two language versions is assessed by Pearson or Spearman correlation (expected r greater than or equal to 0.80), intraclass correlation coefficient (expected greater than or equal to 0.80), and Bland-Altman analysis to detect systematic differences. Bilingual eligibility requires documented criteria beyond self-report. This subgroup is not representative of the main sample and this is reported as a limitation.
Measured: Baseline (Day 1); both language versions administered in the same session, at least 30 minutes apart
Cross-cultural measurement invariance
Comparison of the Turkish item calibration against the original English-language calibration reported by McPhail et al. 2014. The analysis is conditional on the level of source data available from the instrument developer: with raw item-level data, multi-group confirmatory factor analysis testing configural, metric and scalar invariance; with item difficulty estimates only, anchored Rasch calibration with comparison of item difficulty hierarchies. If neither is available, within-sample differential item functioning by sex, age group, treatment modality, recruiting centre and time since injury is reported together with a descriptive comparison against the published psychometric profile.
Measured: At the single study visit (baseline administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start24 Jul 2026
- Primary completion11 Oct 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utku Gürhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Utku Gürhan, University of Kyrenia
- Investigators
- Utku Gurhan, MD, Principal investigator, University of Kyrenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620015
- Sponsor's protocol ID
- AFORM-TR-2026
- Other IDs
- ETK26-GD-0094
- Acronym
- A-FORM-TR
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 24853921Cruchinho 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.
PubMed 38840704Beaton 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.
PubMed 11124735Mokkink 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.
PubMed 20169472
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07620015
- Acronym / sponsor ID
- A-FORM-TR / AFORM-TR-2026
- Conditions
- Ankle Fractures, Ankle Injuries
- Keywords
- patient-reported outcome measure, PROM, cross-cultural adaptation, psychometric validation, ankle fracture, rehabilitation, Rasch analysis, Turkish
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Utku GürhanUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 11 Oct 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: The analysis plan was locked before any field data were collected; all decision rules are pre-specified. 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, reported with the K-index (greater than or equal to 0.70 acceptable for group-level comparison, greater than or equal to 0.90 desirable for individual-level decisions). Measurement error is evaluated separately from reliability as the standard error of measurement and the smallest detectable change. Rasch measurement analysis is the primary framework and 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; pre-specified decision rules govern the handling of item misfit, disordered thresholds and differential item functioning. Confirmatory factor analysis provides a complementary structural test of the prespecified single-factor model, with exploratory factor analysis run as a supplementary check. Construct validity is assessed via pre-specified hypotheses about correlation patterns with the AOFAS and OMAS-TR, and by known-groups comparison across time-since-injury strata. Criterion validity is assessed in a bilingual sub-study of approximately 30 participants completing both the A-FORM-TR and the original English-language A-FORM in counterbalanced order, with agreement quantified by correlation, intraclass correlation and Bland-Altman analysis. Responsiveness is assessed at 3 months against a Global Rating of Change anchor using the standardised response mean (SRM), effect size and receiver operating characteristic (ROC) analysis, with the minimal important change compared against the smallest detectable change. Cross-cultural measurement invariance is examined against the original English calibration, conditional on the source data available from the instrument developer. 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 examined at the scale level. Missing data are reported per item; the primary analysis is complete-case, with multiple imputation as a sensitivity analysis where item-level missingness exceeds 5 percent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal consistency of the A-FORM-TR
Time frame: At the single study visit (baseline administration)
Cronbach's alpha coefficient calculated across all scored items of the A-FORM-TR. Target greater than or equal to 0.80.
Test-retest reliability of the A-FORM-TR
Time frame: Second administration at day 7 and third administration at day 14 after baseline
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. The K-index of agreement is reported alongside the ICC. Thresholds: greater than or equal to 0.70 acceptable for group-level comparison; greater than or equal to 0.90 desirable for individual-level decisions.
10 secondary outcomes
Rasch model fit of the A-FORM-TR
Time frame: At the single study visit (baseline administration)
Structural validity by confirmatory factor analysis
Time frame: At the single study visit (baseline administration)
Construct validity assessed by a priori hypothesis testing
Time frame: At the single study visit (baseline administration)
Content validity of the A-FORM-TR
Time frame: Pre-testing phase, prior to field testing
Distribution properties: floor and ceiling effects
Time frame: At the single study visit (baseline administration)
Known-groups validity by time since injury and treatment modality
Time frame: At the single study visit (baseline administration)
Measurement error of the A-FORM-TR
Time frame: Between baseline and the day 14 administration
Responsiveness of the A-FORM-TR
Time frame: Baseline and 3 months
Criterion validity against the original English A-FORM
Time frame: Baseline (Day 1); both language versions administered in the same session, at least 30 minutes apart
Cross-cultural measurement invariance
Time frame: At the single study visit (baseline administration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 24853921McPhail 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.
- Background: PubMed 38840704Cruchinho 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.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 20169472Mokkink 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Utku Gurhan, MD principal investigator
University of Kyrenia
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures and Ankle Injuries, run by Utku Gürhan at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cyprus, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency of the A-FORM-TR (time frame: At the single study visit (baseline administration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07620015, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.