Ankle SprainsNCT04789369
Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
An observational study of Ankle Sprains, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Athletes who are participating in sportive activities regularly
Who may be able to join
- No injury to the upper or lower extremities during data collection,
- Being older than 18 years of age,
- Individuals who volunteer to participate.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ankle Sprains
- Being tested
- Questionnaires
- Keywords
- Quality of life, Fear of movement, Functionality, Ankle sprain
- Medical subject headings
- Ankle Injuries, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Assessing the behavioral metrics (quality of life, functionality and fear of movement) with appropriate measurement tools
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start15 Mar 2021
- Primary completion15 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789369
- Sponsor's protocol ID
- 2020-04/14
- Status last verified
- Jun 2022
- First submitted
- 5 Mar 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
- ClinicalTrials.gov ID
- NCT04789369
- Acronym / sponsor ID
- 2020-04/14
- Conditions
- Ankle Sprains
- Keywords
- Quality of life, Fear of movement, Functionality, Ankle sprain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Athletes who are participating in sportive activities regularly
Key inclusion criteria (3 listed)
- No injury to the upper or lower extremities during data collection,
- Being older than 18 years of age,
- Individuals who volunteer to participate.
Key exclusion criteria (3 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAssessing the behavioral metrics (quality of life, functionality and fear of movement) with appropriate measurement tools | Behavioural | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprains, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.