- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064502
Chronıc Ankle Instabılıty And Assocıated Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Uğur Şaylı
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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volunteers
273 adult volunteers ranging from 18-78 years old
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Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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chronic ankle instability
Time Frame: 6 months
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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Uğur Şaylı, MD, Prof., Yeditepe University Hospital
- Study Chair: Şule Demirbaş, Asst.Prof., editepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
- Study Chair: Feryal Subaşı, PT, Prof., Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
- Principal Investigator: Ebru Akbuğa, MSc, PT, Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
- Principal Investigator: Elif Tuğçe Çil, MSc, PT, Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeditepeYUPTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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