- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789369
Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
June 2, 2022 updated by: Özgül Öztürk, Acibadem University
The Relationship Between Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
80
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
- Sportomed Fulya Physiotherapy Center
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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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Athletes who are participating in sportive activities regularly
Description
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 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot and Ankle Ability Measure
Time Frame: 1 day
|
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.
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1 day
|
Short Form-12
Time Frame: 1 day
|
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.
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1 day
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Fear Avoidance Beliefs Questionnaire
Time Frame: 1 day
|
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.
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1 day
|
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 15, 2021
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
May 30, 2022
Study Registration Dates
First Submitted
March 5, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 2, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-04/14
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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