Ankle SprainsIdFAI-INCT04516980
Validation of the Identification of Functional Ankle Instability (IdFAI) in Italian
An observational study of Ankle Sprains, run by University of Padova.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Questionnaires administration
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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'
Who may be able to join
- 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'
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Conditions
- Ankle Sprains
- Being tested
- Questionnaires administration
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires administrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with ankle sprain. | Participants with ankle sprain Receives: Other: Questionnaires administration | |
| Participants without ankle sprain | Participants without ankle sprain Receives: Other: Questionnaires administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric parameter 1 validation of the IdFAI scale.
Sample Size homogeneity
Measured: One week
Psychometric parameter 2 validation of the IdFAI scale.
Discriminant validity
Measured: One week
Psychometric parameter 3 validation of the IdFAI scale.
Internal consistency
Measured: One week
Psychometric parameter 4 validation of the IdFAI scale.
Construct validity
Measured: One week
Psychometric parameter 5 validation of the IdFAI scale.
Test-retest reliability
Measured: One week
Psychometric parameter 6 validation of the IdFAI scale.
Criterion validity: convergent and divergent validity
Measured: One week
Psychometric parameter 7 validation of the IdFAI scale.
Floor and ceiling effects
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Martinato, PhD, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516980
- Sponsor's protocol ID
- IdFAI-I
- Acronym
- IdFAI-I
- Status last verified
- Mar 2021
- First submitted
- 13 Aug 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04516980
- Acronym / sponsor ID
- IdFAI-I / IdFAI-I
- Conditions
- Ankle Sprains
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with ankle sprain. | – | Other: Questionnaires administrationParticipants with ankle sprain |
| Participants without ankle sprain | – | Other: Questionnaires administrationParticipants without ankle sprain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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'
Key inclusion criteria (4 listed)
- 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'
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires administrationAdministration 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. | Other | Participants with ankle sprain., Participants without ankle sprain |
Primary outcome
Psychometric parameter 1 validation of the IdFAI scale.
Time frame: One week
Sample Size homogeneity
Psychometric parameter 2 validation of the IdFAI scale.
Time frame: One week
Discriminant validity
Psychometric parameter 3 validation of the IdFAI scale.
Time frame: One week
Internal consistency
Psychometric parameter 4 validation of the IdFAI scale.
Time frame: One week
Construct validity
Psychometric parameter 5 validation of the IdFAI scale.
Time frame: One week
Test-retest reliability
Psychometric parameter 6 validation of the IdFAI scale.
Time frame: One week
Criterion validity: convergent and divergent validity
Psychometric parameter 7 validation of the IdFAI scale.
Time frame: One week
Floor and ceiling effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: Undecided
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Martinato, PhD study director
University of Padova
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprains, run by University of Padova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Martinato, PhD (+393472306806, matteo.martinato@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric parameter 1 validation of the IdFAI scale. (time frame: One week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.