Instability, JointCAIT-INCT04644601
Italian Version of The Cumberland Ankle Instability Tool (CAIT)
An observational study of Instability, Joint and Ankle Sprains, run by University of Bologna at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Instability, Joint, Ankle Sprains, Ankle Injuries
- How many people
- 550 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2021to 16 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: The subjects will be invited to partecipate in this study through contacts with the authors and other colleagues.
Who may be able to join
- Age ≥18 years
- Agreement to voluntarily sign informed consent to participate in the study.
Who cannot join
- Inability to understand the written Italian language
- Pregnancy
- Having undergone a surgery on the ankle-foot area in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi
Bologna, BO, 40138
About this study
Official title: Translation, Cross-cultural Adaptation and and Psychometric Properties of "The Cumberland Ankle Instability Tool (CAIT)" in Italian Language
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.
Read more
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.
Read the 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.
- Conditions
- Instability, Joint, Ankle Sprains, Ankle Injuries, Sport Injury, Chronic Instability of Joint, Chronic Instability, Capsular Ligament
- Keywords
- Instability; Ankle; Sprain, Translation, Runners
- Medical subject headings
- Joint Instability, Ankle Injuries, Sprains and Strains
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: November 2021
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
Measured: November 2021
Secondary outcomes (6)
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 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.
Measured: November 2021
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 α = .05
Measured: June 2022
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.
Measured: June 2022
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.
Measured: June 2022
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.
Measured: June 2022
CAIT-I Floor and Ceiling Effects
Assess CAIT-I Floor and Ceiling Effects in the injured group
Measured: June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start7 Jan 2021
- Primary completion16 Mar 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Instability, JointStudies 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
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Contri, University of Bologna
- Investigators
- Francesco Ballardin, BSc, OMPT, Principal investigator, University of BolognaAngela Contri, MA, OMPT, Principal investigator, University of BolognaMatteo Gaucci, MSc, OMPT, Principal investigator, University of BolognaGian Luca De Marco, BSc, OMPT, Principal investigator, University of BolognaVeronica Zannoni, BSc, OMPT, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644601
- Sponsor's protocol ID
- 273082
- Acronym
- CAIT-I
- Status last verified
- Oct 2022
- First submitted
- 19 Nov 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request the investigators can provide participants (anonymous) data
Publications
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. No abstract available.
PubMed 29258155Beaton 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.
PubMed 11124735Hiller 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.
PubMed 16935061Wright 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.
PubMed 24814563Gribble 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.
PubMed 24255768
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-cultural Adaptation and and Psychometric Properties of "The Cumberland Ankle Instability Tool (CAIT)" in Italian Language
- ClinicalTrials.gov ID
- NCT04644601
- Acronym / sponsor ID
- CAIT-I / 273082
- Conditions
- Instability, Joint, Ankle Sprains, Ankle Injuries, Sport Injury, Chronic Instability of Joint, Chronic Instability, Capsular Ligament
- Keywords
- Instability; Ankle; Sprain, Translation, Runners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 25 Nov 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects will be invited to partecipate in this study through contacts with the authors and other colleagues.
Key inclusion criteria (2 listed)
- Age ≥18 years
- Agreement to voluntarily sign informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Inability to understand the written Italian language
- Pregnancy
- Having undergone a surgery on the ankle-foot area in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
6 secondary outcomes
CAIT-I test-retest reliability
Time frame: November 2021
CAIT-I construct validity
Time frame: June 2022
CAIT-I factor analysis and internal consistency
Time frame: June 2022
CAIT-I sensitivity
Time frame: June 2022
CAIT-I Internal responsiveness
Time frame: June 2022
CAIT-I Floor and Ceiling Effects
Time frame: June 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 29258155Harriss 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. No abstract available.
- Background: PubMed 11124735Beaton 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.
- Results publication: PubMed 16935061Hiller 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.
- Results publication: PubMed 24814563Wright 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.
- Results publication: PubMed 24255768Gribble 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.
- Individual participant dataSharing planned: Yes. On request the investigators can provide participants (anonymous) data
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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.
Francesco Ballardin, BSc, OMPT principal investigator
University of Bologna
Angela Contri, MA, OMPT principal investigator
University of Bologna
Matteo Gaucci, MSc, OMPT principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Instability, Joint and Ankle Sprains, run by University of Bologna at 1 site in Italy.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAIT Score (time frame: November 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644601, which also lists 5 linked publications.
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 13 Oct 2022.