- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816058
Turkish Version of the Ankle Instability Instrument
August 11, 2023 updated by: Özgül Öztürk, Acibadem University
Reliability and Validity of the Turkish Version of the Ankle Instability Instrument
This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population.
Ankle Instability Instrument was developed to determine the ankle instability level of individuals with a history of ankle injury.
Assessment of ankle instability is particularly useful in determining the complaints and functional levels of individuals with a history of functional or chronic ankle instability.
It is anticipated that introducing this scale to our language will contribute to other studies in this field.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul, Turkey
- Acıbadem University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants with a history of ankle injury and healthy population.
Description
Inclusion Criteria:
- History of ankle injury or sprain at least one time
- Aged between 18 to 40 years
Exclusion Criteria:
- Neurological or orthopedic disorders that may affect ankle instability.
Inclusion criteria for healthy population are; no history of ankle injury or sprain before and. aged between 18 to 40 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ankle Instability Group
Patients with a history of ankle instability or injury.
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Ankle instability
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Healthy Group
Participants without a history of ankle injury
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Ankle instability
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle Instability Instrument
Time Frame: 2 weeks
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The Ankle Instability Instrument includes 9 questions that can be answered with yes or no.
The first version was developed with 21 questions and later modified into 9 questions.
The Ankle Instability Instrument determines the development of functional ankle instability in individuals with an ankle injury.
The International Ankle Consortium reported that answering yes to 5 of 9 questions will confirm the presence of functional ankle instability.
There are French and Iran versions of the Ankle Instability Instrument.
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2 weeks
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Cumberland Ankle Instability Tool
Time Frame: 1 day
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The ankle instability levels of the participants included in the study will be determined by the Cumberland Ankle Instability Tool.
The Cumberland Ankle Instability Tool is a self-assessment scale that determines the presence of functional or chronic ankle instability and the severity of the instability.
This scale consists of 9 items and the total score varies between 0 and 30.
Lower scores indicate more severe instability.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form 12
Time Frame: 1 day
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Short Form 12 is a valid and reliable scale for determining the level of quality of life.
This scale consists of 12 items and can be scored as 8 subscales.
These subscales are; physical function, restricted roles due to physical problems, pain, general health, energy / vitality, social functions and mental health with restricted roles due to mental problems.
All items are evaluated with a 5-point Likert-type scale, and higher scores indicate better quality of life while lower scores indicate poor quality of life.
This scale is used to evaluate the quality of life of healthy individuals with any pathology.
Short Form 12 can be scored between 0-100 for each domain.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2021
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 15, 2023
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATADEK-2021-05/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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