NCT05977660

Brief Summary

Cumberland Ankle Instability Tool (CAIT) is a valid patient-reported outcome measure (PROM) to determine the presence of ankle instability (AI) and assess its severity. The aim of current study is to adapt the CAIT into the Turkish language, test its psychometric properties and determine cut-off score in the Turkish population with AI compare to healthy counterparts. In order to evaluate the Turkish version of CAIT (CAIT-TR), data will obtaine from 200-250 participants with and without AI. Test-retest reliability, internal consistency, cut-off score, and ceiling and floor effects will evaluate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 29, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

July 28, 2023

Last Update Submit

February 16, 2024

Conditions

Keywords

ankle instabilitychronic ankle instabilitycumberland ankle instability toolcross-cultural adaptationvalidity and reliabilityself-reported questionnaireCAITTurkish language and cultural adaptation

Outcome Measures

Primary Outcomes (1)

  • Cumberland Ankle Instabililty Tool (CAIT)

    CAIT is a very simple, reliable, and valid measurement tool that is used without comparing with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30, developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle instability. Low scores of the participants indicate poor ankle stability, while high scores indicate good ankle stability .

    two weeks

Study Arms (2)

With chronic ankle instability (CAI)

Participations with CAI diagnosed by a medical doctor

Diagnostic Test: Cumberland ankle instability tool for diagnose to determine ankle instability and its severity

control (without CAI)

Participations without CAI who didn't have any ankle injury 2 years before the study recruitment

Diagnostic Test: Cumberland ankle instability tool for diagnose to determine ankle instability and its severity

Interventions

CAIT is a Patient-reported measures of outcome (PROM) and it is very simple, reliable, and valid measurement tool that is used without comparing with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30, developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle instability. Low scores of the participants indicate poor ankle stability, while high scores indicate good ankle stability.

With chronic ankle instability (CAI)control (without CAI)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

During the research process, the participants will divide into 2 groups, then data will collect. Group 1 includes individuals with or without ankle sprain. These are individuals who do not have a history of injury from sprains and are not seeking treatment for similar reasons. Group 2 consisted of participants who have at least one sprained ankle injury/injury at least 2 months ago and who were seeking treatment in the past or on an ongoing basis.

You may qualify if:

  • Participants consisted of women and men aged between 18 and 35.
  • The volunteers to be included in the study are male and female individuals who have a history of ankle instabililty in the last two months at least for the study group and healthy individuals without any injury and the selection will be made at randomly.

You may not qualify if:

  • As criteria for excluding the participants in the study; Those who have a risk of heart disease, use of pacemaker, epilepsy, transient ischemic attack, stroke or similar nervous disorders and any similar health problems,
  • Those with psychiatric, cardiac, pulmonary diseases, pregnant women, those who use drugs that affect the heart rate and blood pressure, those with systemic, neuroplastic, inflammation disorders, those with structural back anomalies, and those who have had lumbar disc herniation complications will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Technical University

Eskişehir, Tepebaşı, 26555, Turkey (Türkiye)

Location

Related Publications (1)

  • Mercanoglu AO, Kacoglu C, Atalay E. Cross-Cultural Adaptation and Cutoff Score Determination of the Turkish Version of the Cumberland Ankle Instability Tool in Recreationally Active Individuals. Orthop J Sports Med. 2025 Aug 19;13(8):23259671251358407. doi: 10.1177/23259671251358407. eCollection 2025 Aug.

MeSH Terms

Conditions

Ankle InjuriesJoint Instability

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Erdem Atalay, Md. Phd.

    Department of Sport Medicine, Eskişehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated profesor

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 4, 2023

Study Start

July 29, 2023

Primary Completion

September 10, 2023

Study Completion

October 25, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations