Italian Version of The Cumberland Ankle Instability Tool (CAIT)

Ankle Injuries Clinical Trial

— CAIT-I  

Official title:

Translation, Cross-cultural Adaptation and and Psychometric Properties of "The Cumberland Ankle Instability Tool (CAIT)" in Italian Language

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644601
• Other study ID #: 273082
• Status: Completed
• Start date: January 7, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: October 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: June 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Inversion Sprain
• Ankle Sprains
• Athletic Injuries
• Chronic Instability of Joint
• Chronic Instability, Capsular Ligament
• Instability, Joint
• Joint Instability
• Sport Injury
• Sprains and Strains
• Wounds and Injuries

Locations

Country	Name	City	State
Italy	Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View 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 — View Citation

Harriss DJ, Macsween A, Atkinson G. Standards for Ethics in Sport and Exercise Science Research: 2018 Update. Int J Sports Med. 2017 Dec;38(14):1126-1131. doi: 10.1055/s-0043-124001. Epub 2017 Dec 19. — View 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. — View 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAIT Score	The Cumberland Ankle Instability Tool is a 9-item questionnaire designed to evaluate both ankles concerning pain in each ankle for daily activities, ankle instability in different types of physical activities, ankle control when recurrent sprain occurring and recovery period after recurrent ankle sprains. The nine items generate a total score from 0 to 30 for each foot, in which 0 is the worst possible score, meaning severe instability, 30 is the best possible score, meaning normal stability	November 2021
Primary	Validate the Italian translation of the CAIT-I	The score between the CAIT-I versus the italian validated version of the Short Form Health Survey (SF-36) will be compared	November 2021
Secondary	CAIT-I test-retest reliability	Assess CAIT-I test-retest reliability in adults with and without chronic ankle instability. Test-retest reliability will be assessed with 1 group (including "healthy" and "injured" participants), 2 measurements (test-retest), with an effect size change of 0.25, power of 0.95, and a significance level of a = .05. Test-retest reliability analysis separately will compare combined, healthy, and injured groups for the CAIT total score. The ICC values of 0.49 or less will be considered low, 0.50 to 0.69 moderate, 0.70 to 0.89 high, and 0.90 to 1.00 very high.	November 2021
Secondary	CAIT-I construct validity	Assess CAIT-I construct validity in with 1 group (adult with and without chronic ankle instability), with an effect-size change of 0.25, power of 0.95, and a significance level of a = .05	June 2022
Secondary	CAIT-I factor analysis and internal consistency	Assess CAIT-I factor analysis and internal consistency in adults with and without chronic ankle instability. Cronbach's alpha will be calculate to estimate internal item consistency.	June 2022
Secondary	CAIT-I sensitivity	Assess CAIT-I sensitivity in adults with and without chronic ankle instability. To conduct sensitivity analyses in the healthy group and injured group, the researchers will conduct a t test for equal variances not assumed and a significant Levene's test.	June 2022
Secondary	CAIT-I Internal responsiveness	To determine internal responsiveness, differences in CAIT-I and SF-36 scores in injured participants across 4 time points using repeated-measures (time) analysis of variance in SPSS.	June 2022
Secondary	CAIT-I Floor and Ceiling Effects	Assess CAIT-I Floor and Ceiling Effects in the injured group	June 2022