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Validation of the Identification of Functional Ankle Instability (IdFAI) in Italian

Cross-cultural Translation, Adaptation and Psychometric Validation of the Functional Ankle Instability (IdFAI) in an Italian Population With or Without Ankle Instability - A Non-interventional Web-based Cross-sectional Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04516980
Acronym
IdFAI-I
Enrollment
200
Registered
2020-08-18
Start date
2021-05-31
Completion date
2022-06-30
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

Brief summary

The purpose of the study is actually the translation, cultural adaptation and psychometric validation in the Italian Version of the Identification of Functional Ankle Instability (IdFAI) English Version for use in outpatient clinics in non-English subjects to objectify chronic ankle instability.

Detailed description

The hypothesis is to translate and culturally adapt the scale successfully and demonstrate a good factorial structure and psychometric properties, replicating the results of the original English version of the questionnaire

Interventions

Administration of Identification of Functional Ankle Instability (IdFAI) and the following assessment scales: Self-reported question assess the ankle instability as functional/stable or not functional/unstable, Foot and Ankle ability Measure Italian Version - Activity Daily Living (FAAM-I/ADL), Short-form 36-item Health Survey Italian Version (SF-36), Numeric Rate Scale pain (NRS Pain), Visual Analogic Scale Ankle Instability (VAS ankle instability). After a week the participants will fill in the following questionnaires: Identification of Functional Ankle Instability (IdFAI), Numeric Rate Scale pain (NRS Pain), Visual Analogic Scale Ankle Instability (Vas ankle instability) with the additional question to measure the change in complaints.

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants without ankle sprain. 1. Age ≥ 18aa 2. Speak Italian on a daily basis 3. No pathologies or surgical treatments in the lower limbs currently or in the past Participants with ankle sprain. Inclusion Criteria 1. Age ≥ 18aa 2. Speak Italian on a daily basis 3. At least one ankle sprain 4. Recurrent sprain to the same ankle and/or sensation of ankle instability and/or 'giving way'

Exclusion criteria

1. Inability to understand written Italian 2. Acute lower extremity injury occurred in the three months preceding the compilation of the questionnaire 3. History of others lower extremity musculoskeletal diseases or injuries of other joints (i.e, hip, knee), previous ankle fractures or systemic pathologies (i.e., neurological disorders, rheumatoid arthritis) currently or in the past 4. History of surgical treatments in either lower limb (bones, joints, nerves)

Design outcomes

Primary

MeasureTime frameDescription
Psychometric parameter 1 validation of the IdFAI scale.One weekSample Size homogeneity
Psychometric parameter 2 validation of the IdFAI scale.One weekDiscriminant validity
Psychometric parameter 3 validation of the IdFAI scale.One weekInternal consistency
Psychometric parameter 4 validation of the IdFAI scale.One weekConstruct validity
Psychometric parameter 5 validation of the IdFAI scale.One weekTest-retest reliability
Psychometric parameter 6 validation of the IdFAI scale.One weekCriterion validity: convergent and divergent validity
Psychometric parameter 7 validation of the IdFAI scale.One weekFloor and ceiling effects

Contacts

Primary ContactMatteo Martinato, PhD
matteo.martinato@unipd.it+393472306806
Backup ContactService for Clinical Trials and Biometrics
sctb.dctv@unipd.it+390498275646

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026