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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04789369
Other study ID # 2020-04/14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date May 30, 2022

Study information

Verified date June 2022
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ankle sprain is frequently experienced by individuals participating in different sports activities. Ankle sprains have been shown to result in a decrease in level of physical activity and persistence of some symptoms for a long time. In this case, it is predicted that ankle sprains may affect the quality of life as well as functionality. Also, ankle sprain history may result in increased fear of movement, which may delay return to sports. This study aimed to examine the relationship between foot and ankle functionality, fear of movement and quality of life of elite athletes with a history of ankle sprain.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 30, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - No injury to the upper or lower extremities during data collection, - Being older than 18 years of age, - Individuals who volunteer to participate. Exclusion Criteria: . Having had ankle surgery, - Has had an injury to his lower extremity in the last 3 months, - Individuals with a history of neurological / neuropsychiatric disease or arthritis will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaires
Assessing the behavioral metrics (quality of life, functionality and fear of movement) with appropriate measurement tools

Locations

Country Name City State
Turkey Sportomed Fulya Physiotherapy Center Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Foot and Ankle Ability Measure The Foot and Ankle Ability Measure will be used to determine the ankle functionality. This scale was developed to determine lower extremity functional level. It evaluates the level of difficulty of the person in activities in daily life in 21 items with a 5-point Likert-type scale, which means "4 = not difficult at all" and "0 = I cannot do it". At the same time, it can be reported within the scope of the scale that the specified activity cannot be implemented. High score means better functions. 1 day
Primary 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 which are physical function, restricted roles due to physical problems, pain, general health, energy / vitality, social functions, mental health and mental health with restricted roles due to emotional problems. All items are evaluated with a 5-point Likert-type scale, and higher scores indicate better quality of life. 1 day
Primary Fear Avoidance Beliefs Questionnaire The FABQ measures athletes' fear of pain and consequent avoidance of physical activity or sports because of their increased fear. The questionnaire contains 16 items between 0 and 6 while 0 indicates completely disagree and 6 indicates completely agree. The maximum score is 96 and higher scores indicates increased level of fear avoidance beliefs. 1 day
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