Clinical trial NCT04644601: Italian Version of The Cumberland Ankle Instability Tool (CAIT)
Official title: Translation, Cross-cultural Adaptation and and Psychometric Properties of "The Cumberland Ankle Instability Tool (CAIT)" in Italian Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Instability, Joint
Ankle Sprains
Ankle Injuries
Sport Injury
Chronic Instability of Joint
Chronic Instability, Capsular Ligament
Ankle Inversion Sprain
Keywords: Instability; Ankle; Sprain, Translation, Runners
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be invited to partecipate in this study through contacts with the authors and other colleagues.

Brief summary: Study Design: Evaluation of the psychometric properties of a translated, culturally adapted questionnaire.

Objective: Translating, culturally adapting, and validating the Italian version of the Cumberland Ankle Instability Tool (CAIT-I), allowing its use with Italian-speaking population to monitor both state of health and functional limitation deriving from ankle instability problems, in order to evaluate the degree of severity, without using the comparison with the opposite limb.

Summary of Background Data: Lateral ankle sprain is the most common injury during sports activity, often cause of disability and of numerous complications following repeated episodes, including chronic ankle instability (CAI), which affects 32% to 74% of the aforementioned cases.

Growing attention is devoted to standardized outcome measures to improve interventions for injured population.

A translated form of the Cumberland Ankle Instability Tool (CAIT), a simple and specific tool for diagnosing chronic lateral ankle instability with excellent psychometric characteristics of both reliability and validity, has never been validated within the Italian speaking population.

Detailed description: The Cumberland Ankle Instability Tool (CAIT) is a simple 9-item, validated and specific tool for diagnosing chronic lateral ankle instability. This rating scale was first published in 2006, and it is a useful tool as a diagnostic criterion, as a screening tool, a prognostic tool, a outcome and clinical picture severity measure tool.

The CAIT-I questionnaire will be developed involving forward-backward translation, a final re-evaluation made by a representative multidisciplinary expert committee and the realization of a prefinal version to establish a proper correspondence with the original English version.

Once an acceptability analysis has been conducted, the following will be analyzed: 1- The validity of the construct by comparing the CAIT-I data with those of the SF-36 using Pearson's correlations ; 2- An Exploratory Factorial Analysis and one of Internal Consistency; 3 Sensitivity analysis through the development of ROC curves and analysis of the area under the curve. In a subset of at least 36 participants the investigators will determine the internal responsiveness on 4 points using an ANOVA (P \<.05). The scores of participants with Chronic Instability will be analyzed to determine the presence of ceiling or floor effects. Standard psychometric techniques will be used.

The validation of the psychometric properties of the instrument will start after it will been administered digitally, via a link to a website built using LimeSurvey, an application based on a MySQL database that allows the realization of online surveys, to a sample population of at least 197 subjects (a priori sample number calculated through the G \* Power program) aged 18 or more recruited through sports associations and health professionals who work with sports subjects. Through this link, from the time it will be online up to 16 November 2021, the participants will be able to access the online questionnaire, only after accepting a form for requesting consent to the processing of personal data updated pursuant to article 13 of the GDPR 2016 / 679, in force in all European Union countries from 25 May 2018. Inclusion criteria: - Age ≥18 years - Agreement to voluntarily sign informed consent to participate in the study. Exclusion criteria: - Inability to understand the written Italian language - Pregnancy - Having undergone an ankle-foot surgery in the last 6 months.

Upon enrollment, participants will answer a demographics questionnaire, the CAIT-I, and the SF-36. If they will take part in the reliability portion, then they filled out the CAIT-I and SF-36 a second time within 4 to 9 days.

For the statistical analysis standard psychometric techniques will be used, such as reliability assessments, convergent and discriminant validity tests of each item and of the construct in its entirety, empirical validity tests in relation to the clinical status and formal tests to assess their accuracy to ends to test the hypotheses.

The investigators hypothesize to be able to reproduce a tool that reflects the characteristics of the CAIT in the original language and therefore it will prove to have, even in its Italian version, an acceptable psychometric performance as an outcome and screening measure for chronic ankle instability. The CAIT-I will show to be a useful tool that can be used as a functional outcome measure for the Italian population, to monitor both the state of health and residual functional limitation in adults.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Agreement to voluntarily sign informed consent to participate in the study.

Exclusion Criteria:

* Inability to understand the written Italian language
* Pregnancy
* Having undergone a surgery on the ankle-foot area in the last 6 months.

Primary outcomes:
measure: CAIT Score
timeFrame: November 2021
measure: Validate the Italian translation of the CAIT-I
timeFrame: November 2021
Secondary outcomes:
measure: CAIT-I test-retest reliability
timeFrame: November 2021
measure: CAIT-I construct validity
timeFrame: June 2022
measure: CAIT-I factor analysis and internal consistency
timeFrame: June 2022
measure: CAIT-I sensitivity
timeFrame: June 2022
measure: CAIT-I Internal responsiveness
timeFrame: June 2022
measure: CAIT-I Floor and Ceiling Effects
timeFrame: June 2022
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi
state: BO
Study officials:
affiliation: University of Bologna
name: Francesco Ballardin, BSc, OMPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: Angela Contri, MA, OMPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: Matteo Gaucci, MSc, OMPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: Gian Luca De Marco, BSc, OMPT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bologna
name: Veronica Zannoni, BSc, OMPT
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
citation: Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
citation: Wright CJ, Arnold BL, Ross SE, Linens SW. Recalibration and validation of the Cumberland Ankle Instability Tool cutoff score for individuals with chronic ankle instability. Arch Phys Med Rehabil. 2014 Oct;95(10):1853-9. doi: 10.1016/j.apmr.2014.04.017. Epub 2014 May 9.
citation: Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty C, Fourchet F, Fong DT, Hertel J, Hiller C, Kaminski T, McKeon P, Refshauge K, van der Wees P, Vicenzino B, Wikstrom E. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. Br J Sports Med. 2014 Jul;48(13):1014-8. doi: 10.1136/bjsports-2013-093175. Epub 2013 Nov 19.