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

Ankle Sprains Clinical Trial

— IdFAI-I  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04516980
• Other study ID #: IdFAI-I
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: June 2022

Study information

• Verified date: March 2021
• Source: University of Padova
• Contact: Matteo Martinato, PhD
• Phone: +393472306806
• Email: matteo.martinato[@]unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Outcome

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