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

NCT ID: NCT04516980

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-31

Study Completion Date

2022-06-30

Brief Summary

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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

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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

Conditions

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Ankle Sprains

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants with ankle sprain.

Participants with ankle sprain

Questionnaires administration

Intervention Type 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 without ankle sprain

Participants without ankle sprain

Questionnaires administration

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matteo Martinato, PhD

Role: STUDY_DIRECTOR

University of Padova

Central Contacts

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Matteo Martinato, PhD

Role: CONTACT

+393472306806

Service for Clinical Trials and Biometrics

Role: CONTACT

+390498275646

Other Identifiers

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IdFAI-I

Identifier Type: -

Identifier Source: org_study_id

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