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

March 23, 2021 updated by: University of Padova

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Service for Clinical Trials and Biometrics
  • Phone Number: +390498275646
  • Email: sctb.dctv@unipd.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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'

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with ankle sprain.
Participants with ankle sprain
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.
Participants without ankle sprain
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychometric parameter 1 validation of the IdFAI scale.
Time Frame: One week
Sample Size homogeneity
One week
Psychometric parameter 2 validation of the IdFAI scale.
Time Frame: One week
Discriminant validity
One week
Psychometric parameter 3 validation of the IdFAI scale.
Time Frame: One week
Internal consistency
One week
Psychometric parameter 4 validation of the IdFAI scale.
Time Frame: One week
Construct validity
One week
Psychometric parameter 5 validation of the IdFAI scale.
Time Frame: One week
Test-retest reliability
One week
Psychometric parameter 6 validation of the IdFAI scale.
Time Frame: One week
Criterion validity: convergent and divergent validity
One week
Psychometric parameter 7 validation of the IdFAI scale.
Time Frame: One week
Floor and ceiling effects
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Matteo Martinato, PhD, University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IdFAI-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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