Italian Version of The Cumberland Ankle Instability Tool (CAIT)

NCT04644601 | Completed

• 1 other identifier: 273082
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• CAIT-I test-retest reliability

  November 2021

• CAIT-I construct validity

  June 2022

• CAIT-I factor analysis and internal consistency

  June 2022

• CAIT-I sensitivity

  June 2022

• CAIT-I Internal responsiveness

  June 2022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

Related Publications (5)

• 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.

  PMID: 29258155 BACKGROUND

• 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.

  PMID: 11124735 BACKGROUND

• 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.

  PMID: 16935061 RESULT

• 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.

  PMID: 24814563 RESULT

• 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.

  PMID: 24255768 RESULT

MeSH Terms

Conditions

Joint Instability; Ankle Injuries; Sprains and Strains

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: January 7, 2021
• Primary Completion: March 16, 2022
• Study Completion: June 16, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Forever
• Access Criteria: Free

Locations

IT (1)