Chronic Ankle InstabilityNCT04064502
Chronıc Ankle Instabılıty And Assocıated Factors
An observational study of Chronic Ankle Instability, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:
- How many people
- 273 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 1 Sep 2018
- 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 34 years
- All sexes
- No healthy volunteers
- Adult
Study population: The cross-sectional study group consisted of 273 adult volunteers, ranging from 18-78 years old, who were recruited via social media to maximize outreach and insure a diverse target group.
Who may be able to join
- being volunteer
- volunteers above 18 years old
Who cannot join
- history of acute ankle sprain
- acute ankle fracture
- receiving/having received physiotherapy and rehabilitation programs for foot and ankle problems
- within the last 6 months,history of foot, ankle, and/or knee surgery
- neuromuscular disorders
- disorders affecting balance
- diabetes mellitus complications
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors. The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.
Read the detailed description
Chronic ankle instability (CAI) is a common condition encountered with persistent symptoms of giving way, pain, and weakness and recurrent risk, which may lead to functional insufficiency. The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors.
The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot. 273 adult volunteers participated in the study, through face to face or online. Subjects are classified as having CAI with a CAIT score ≤27.
- Conditions
- Chronic Ankle Instability
- Being tested
- CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:
- Keywords
- Chronic Ankle Instability, Cumberland Ankle Instability Tool, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:Diagnostic test
Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.
| Study group | Role | What they receive |
|---|---|---|
| volunteers | 273 adult volunteers ranging from 18-78 years old Receives: Diagnostic Test: CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS: |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic ankle instability
Cumberland Ankle Instability Tool
(CAIT) is a 9-item questionnaire generating a score from 0 to 30 for each ankle, in which 0 is the worst possible score, meaning severe instability, and 30 is the best possible score, meaning stability. The CAIT is considered a reliable instrument to distinguish between stable and unstable ankles, meanwhile, measuring the severity of functional ankle instability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 May 2017
- Primary completion1 Dec 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University Hospital
- Responsible party
- Sponsor
- Investigators
- Uğur Şaylı, MD, Prof., Study chair, Yeditepe University HospitalŞule Demirbaş, Asst.Prof., Study chair, editepe University, Faculty of Health Sciences, Deparment of Physiotherapy and RehabilitationFeryal Subaşı, PT, Prof., Study chair, Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and RehabilitationEbru Akbuğa, MSc, PT, Principal investigator, Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and RehabilitationElif Tuğçe Çil, MSc, PT, Principal investigator, Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064502
- Sponsor's protocol ID
- YeditepeYUPTR
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronıc Ankle Instabılıty And Assocıated Factors
- ClinicalTrials.gov ID
- NCT04064502
- Acronym / sponsor ID
- YeditepeYUPTR
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic Ankle Instability, Cumberland Ankle Instability Tool, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Yeditepe University Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 22 Aug 2019 (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.
The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors. The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.
Detailed description
Chronic ankle instability (CAI) is a common condition encountered with persistent symptoms of giving way, pain, and weakness and recurrent risk, which may lead to functional insufficiency. The purpose of this study was to evaluate the prevalence of chronic ankle instability using the Cumberland Ankle Instability Tool (CAIT) and investigate the independent associated factors.
The data was collected from adult volunteers by questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot. 273 adult volunteers participated in the study, through face to face or online. Subjects are classified as having CAI with a CAIT score ≤27.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | – | Diagnostic Test: CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:273 adult volunteers ranging from 18-78 years old |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The cross-sectional study group consisted of 273 adult volunteers, ranging from 18-78 years old, who were recruited via social media to maximize outreach and insure a diverse target group.
Key inclusion criteria (2 listed)
- being volunteer
- volunteers above 18 years old
Key exclusion criteria (7 listed)
- history of acute ankle sprain
- acute ankle fracture
- receiving/having received physiotherapy and rehabilitation programs for foot and ankle problems
- within the last 6 months,history of foot, ankle, and/or knee surgery
- neuromuscular disorders
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 |
|---|---|---|
| CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot. | Diagnostic test | volunteers |
Primary outcome
chronic ankle instability
Time frame: 6 months
Cumberland Ankle Instability Tool (CAIT) is a 9-item questionnaire generating a score from 0 to 30 for each ankle, in which 0 is the worst possible score, meaning severe instability, and 30 is the best possible score, meaning stability. The CAIT is considered a reliable instrument to distinguish between stable and unstable ankles, meanwhile, measuring the severity of functional ankle instability.
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 22 Aug 2019.
- Individual participant dataSharing planned: Yes
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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.
Uğur Şaylı, MD, Prof. study chair
Yeditepe University Hospital
Şule Demirbaş, Asst.Prof. study chair
editepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
Feryal Subaşı, PT, Prof. study chair
Yeditepe University, Faculty of Health Sciences, Deparment of Physiotherapy and Rehabilitation
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 Chronic Ankle Instability, run by Yeditepe 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 2 inclusion and 7 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 22 Aug 2019. 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?
chronic ankle instability (time frame: 6 months). 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 22 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.