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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04064502
Other study ID # YeditepeYUPTR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date September 1, 2018

Study information

Verified date July 2019
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors. The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.


Description:

Chronic ankle instability (CAI) is a common condition encountered with persistent symptoms of giving way, pain, and weakness and recurrent risk, which may lead to functional insufficiency. The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors.

The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot. 273 adult volunteers participated in the study, through face to face or online. Subjects are classified as having CAI with a CAIT score ≤27.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date September 1, 2018
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 34 Years
Eligibility Inclusion Criteria:

- being volunteer

- volunteers above 18 years old

Exclusion Criteria:

- history of acute ankle sprain

- acute ankle fracture

- receiving/having received physiotherapy and rehabilitation programs for foot and ankle problems

- within the last 6 months,history of foot, ankle, and/or knee surgery

- neuromuscular disorders

- disorders affecting balance

- diabetes mellitus complications

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:
Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.

Locations

Country Name City State
Turkey Ugur Sayli Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Yeditepe University Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary chronic ankle instability Cumberland Ankle Instability Tool
(CAIT) is a 9-item questionnaire generating a score from 0 to 30 for each ankle, in which 0 is the worst possible score, meaning severe instability, and 30 is the best possible score, meaning stability. The CAIT is considered a reliable instrument to distinguish between stable and unstable ankles, meanwhile, measuring the severity of functional ankle instability.
6 months
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