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Chronıc Ankle Instabılıty And Assocıated Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064502
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Yeditepe University Hospital
Information provided by (Responsible Party):
Yeditepe University

Brief 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.

Condition or disease Intervention/treatment
Chronic Ankle Instability Diagnostic Test: CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:

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.

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Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Chronıc Ankle Instabılıty And Assocıated Factors
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : September 1, 2018

Group/Cohort Intervention/treatment
volunteers
273 adult volunteers ranging from 18-78 years old
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.




Primary Outcome Measures :
  1. chronic ankle instability [ Time Frame: 6 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The cross-sectional study group consisted of 273 adult volunteers, ranging from 18-78 years old, who were recruited via social media to maximize outreach and insure a diverse target group.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064502


Locations
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Turkey
Uğur Şaylı
Istanbul, Turkey
Sponsors and Collaborators
Yeditepe University
Yeditepe University Hospital
Investigators
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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
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Responsible Party: Yeditepe University
ClinicalTrials.gov Identifier: NCT04064502    
Other Study ID Numbers: YeditepeYUPTR
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeditepe University:
Chronic Ankle Instability
Cumberland Ankle Instability Tool
Pain
Additional relevant MeSH terms:
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Joint Instability
Joint Diseases
Musculoskeletal Diseases