UnknownNot Applicable

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

200 participantsStarted 2021-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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'

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychometric parameter 1 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 2 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 3 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 4 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 5 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 6 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 7 validation of the IdFAI scale.

Timeframe: One week

Trial details

NCT IDNCT04516980

SponsorUniversity of Padova

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05

Contact for this trial

Matteo Martinato, PhD

+393472306806 matteo.martinato@unipd.it

View on ClinicalTrials.gov More Ankle Sprains trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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'

Exclusion criteria

. 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)

What they're measuring

Psychometric parameter 1 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 2 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 3 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 4 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 5 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 6 validation of the IdFAI scale.

Timeframe: One week

Psychometric parameter 7 validation of the IdFAI scale.

Timeframe: One week