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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Sprains
• Intervention / Treatment: Other: Questionnaires administration

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Matteo Martinato, PhD; Phone Number: +393472306806; Email: matteo.martinato@unipd.it
• Study Contact Backup: Name: Service for Clinical Trials and Biometrics; Phone Number: +390498275646; Email: sctb.dctv@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects, speaking Italian, without lower limbs current disease or history of lower limbs disease or surgical tretmens in the lower limbs.

Adult subjects, speaking Italian, with at least one ankle sprain and recurrent sprain to the same ankle and/or sensation of ankle instability and/or 'giving way'

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with ankle sprain.; Participants with ankle sprain	Other: Questionnaires administration; 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.
Participants without ankle sprain	Other: Questionnaires administration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychometric parameter 1 validation of the IdFAI scale.	Sample Size homogeneity	One week
Psychometric parameter 2 validation of the IdFAI scale.	Discriminant validity	One week
Psychometric parameter 3 validation of the IdFAI scale.	Internal consistency	One week
Psychometric parameter 4 validation of the IdFAI scale.	Construct validity	One week
Psychometric parameter 5 validation of the IdFAI scale.	Test-retest reliability	One week
Psychometric parameter 6 validation of the IdFAI scale.	Criterion validity: convergent and divergent validity	One week
Psychometric parameter 7 validation of the IdFAI scale.	Floor and ceiling effects	One week

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Study Director: Matteo Martinato, PhD, University of Padova

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: IdFAI-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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