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Italian Version of The Cumberland Ankle Instability Tool (CAIT) (CAIT-I)

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ClinicalTrials.gov Identifier: NCT04644601
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Angela Contri, University of Bologna

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.


Condition or disease
Instability, Joint Ankle Sprains Ankle Injuries Sport Injury Chronic Instability of Joint Chronic Instability, Capsular Ligament Ankle Inversion Sprain

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 we 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.

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Study Type : Observational
Estimated Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Translation, Cross-cultural Adaptation and and Psychometric Properties of "The Cumberland Ankle Instability Tool (CAIT)" in Italian Language
Actual Study Start Date : January 7, 2021
Estimated Primary Completion Date : November 16, 2021
Estimated Study Completion Date : June 16, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. CAIT Score [ Time Frame: November 2021 ]
    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

  2. Validate the Italian translation of the CAIT-I [ Time Frame: November 2021 ]
    The score between the CAIT-I versus the italian validated version of the Short Form Health Survey (SF-36) will be compared


Secondary Outcome Measures :
  1. CAIT-I test-retest reliability [ Time Frame: November 2021 ]
    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 α = .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.

  2. CAIT-I construct validity [ Time Frame: June 2022 ]
    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 α = .05

  3. CAIT-I factor analysis and internal consistency [ Time Frame: June 2022 ]
    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.

  4. CAIT-I sensitivity [ Time Frame: June 2022 ]
    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.

  5. CAIT-I Internal responsiveness [ Time Frame: June 2022 ]
    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.

  6. CAIT-I Floor and Ceiling Effects [ Time Frame: June 2022 ]
    Assess CAIT-I Floor and Ceiling Effects in the injured group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644601


Contacts
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Contact: Angela Scariato, BSc, OMPT +393477685990 scariato.fisiosport@gmail.com
Contact: Angela Contri, MA, OMPT +393478824741 angela.contri@libero.it

Locations
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Italy
Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi Recruiting
Bologna, BO, Italy, 40138
Contact: Paolo Pillastrini, Pt, MSc    +390512142496    paolo.pillastrini@unibo.it   
Principal Investigator: Angela Scariato, BSc, OMPT         
Principal Investigator: Francesco Ballardin, BSc, OMPT         
Principal Investigator: Angela Contri, MA, OMPT         
Principal Investigator: Matteo Gaucci, MSc, OMPT         
Principal Investigator: Gianluca De Marco, BSc, OMPT         
Principal Investigator: Veronica Zannoni, BSc, OMPT         
Sub-Investigator: Vanti Carla, MSc, OMPT         
Sub-Investigator: Paolo Pillastrini, MSc, OMPT         
Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Francesco Ballardin, BSc, OMPT University of Bologna
Principal Investigator: Angela Contri, MA, OMPT University of Bologna
Principal Investigator: Matteo Gaucci, MSc, OMPT University of Bologna
Principal Investigator: Gian Luca De Marco, BSc, OMPT University of Bologna
Principal Investigator: Veronica Zannoni, BSc, OMPT University of Bologna
Publications of Results:
Other Publications:
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Responsible Party: Angela Contri, Principal Investigator, University of Bologna
ClinicalTrials.gov Identifier: NCT04644601    
Other Study ID Numbers: 273082
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: Forever
Access Criteria: Free

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela Contri, University of Bologna:
Instability; Ankle; Sprain, Translation, Runners
Additional relevant MeSH terms:
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Joint Instability
Wounds and Injuries
Sprains and Strains
Ankle Injuries
Athletic Injuries
Leg Injuries
Joint Diseases
Musculoskeletal Diseases