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

NCT04516980 | Unknown

• 1 other identifier: IdFAI-I
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Sprains

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Participants with ankle sprain.

Participants with ankle sprain

Other: Questionnaires administration

Participants without ankle sprain

Participants without ankle sprain

Other: Questionnaires administration

Interventions

Questionnaires administration OTHER

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 with ankle sprain.; Participants without ankle sprain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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'

You may qualify if:

• Age ≥ 18aa
• Speak Italian on a daily basis
• At least one ankle sprain
• Recurrent sprain to the same ankle and/or sensation of ankle instability and/or 'giving way'

You may not qualify if:

• Inability to understand written Italian
• Acute lower extremity injury occurred in the three months preceding the compilation of the questionnaire
• 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
• History of surgical treatments in either lower limb (bones, joints, nerves)

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Matteo Martinato, PhD

  University of Padova

  STUDY DIRECTOR

Central Study Contacts

Matteo Martinato, PhD

CONTACT

+393472306806; matteo.martinato@unipd.it

Service for Clinical Trials and Biometrics

CONTACT

+390498275646; sctb.dctv@unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 24, 2021

Record last verified: 2021-03