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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04816058
Other study ID # ATADEK-2021-05/09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 25, 2021
Est. completion date July 15, 2023

Study information

Verified date August 2023
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date July 15, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Determining the level of ankle instability
Ankle instability

Locations

Country Name City State
Turkey Acibadem University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ankle Instability Instrument 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. 2 weeks
Primary Cumberland Ankle Instability Tool 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. 1 day
Secondary Short Form 12 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. 1 day
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