Chronic Ankle SprainNCT07449078
Investigating the Effects of Cognitive Functional Therapy on Pain, Physical Function, and Kinesiophobia in Individuals With Chronic Ankle Sprain
A study testing Cognitive Functional Therapy in people with Chronic Ankle Sprain and Chronic Ankle Sprains, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Ankle Sprain, Chronic Ankle Sprains
- What is being tested?
- Cognitive Functional Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing pain or swelling, "giving way" episodes, and re-injury during sports or daily activity
- Adults aged 18-65 years
- History of lateral ankle sprain with symptoms persisting for more than 3 months
- Continuing symptoms such as pain, instability, or activity limitations
- Ability to understand and communicate in English or Arabic
Who cannot join
- History of ankle surgery within the past 12 months
- Advanced ankle osteoarthritis or systemic inflammatory, neurological, or vestibular conditions
- Currently undergoing physiotherapy for the same condition
- Cognitive impairment or severe psychological disorder that could interfere with participation
- Pregnancy or planned pregnancy during the study period
- Any other condition deemed unsuitable by the research team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe University
Istanbul, Ataşehir, 34775
Dr. Öğr. Üyesi Elif Tuğçe Çil Dr. Öğr. Üyesi Elif Tuğçe Çil, Dr. Ogr. Uyesi, 0090 554 481 10 92, tugce.cill@gmail.com
About this study
The aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS).
Read the detailed description
The aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS). This study will follow a structured clinical research protocol designed to evaluate the effects of Cognitive Functional Therapy (CFT) on individuals with chronic ankle sprain.
This study is an experimental clinical intervention with a two-time-point measurement design. The Cognitive Functional Therapy (CFT) program will be applied to individuals with chronic ankle sprain, and its effects will be evaluated at baseline (before intervention) and after the 12-week intervention.
The study will take place between January 2026 and June 2026. All participants will undergo an initial eligibility screening by an orthopedic specialist prior to enrollment. Following informed consent, eligible participants will attend a baseline assessment session, complete validated self-report questionnaires, and then begin a 12-week individualized CFT program consisting of seven sessions. Interventions will be delivered by a trained physiotherapist with clinical experience in musculoskeletal rehabilitation and certification in CFT principles. All data collection, including digital files and paper records, will be securely stored in encrypted systems accessible only to the research team. At the conclusion of the 12-week program, participants will fill the same questionnaires they filled at the beginning of the study as an outcome measurement.
The outcome measurements are VAS, TSK-17, and FAAM questionnaires.
- Conditions
- Chronic Ankle Sprain, Chronic Ankle Sprains
- Being tested
- Cognitive Functional Therapy
- Keywords
- Chronic Ankle Sprain, CAS, CFT, Cognitive Functional Therapy, Behavior, Beliefs
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Functional TherapyProcedure or surgery
Cognitive Functional Therapy is an integrated behavioral approach for individualizing the management of people with chronic pain, originally developed for Low Back Pain Patients. It uses a multidimensional "clinical reasoning framework" to identify key modifiable targets for management on the basis of careful listening to the individual's story and examining the individual's behavioral responses to pain. This approach enables the treating clinician to take individuals on a journey to effectively self-manage their chronic pain with a program that is tailored to their unique clinical presentation and context.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy Group | Experimental | Cognitive Functional Therapy Receives: Procedure: Cognitive Functional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAAM
Foot and Ankle Ability Measure
Measured: 12 Weeks
TSK-17
Tampa Scale of Kinesiophobia
Measured: 12 Weeks
VAS
Visual Analogue Scale
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start6 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle SprainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdullah Omar Alwakil, Bachelor, Principal investigator, Yeditepe UniversityDr. Öğr. Üyesi Elif Tuğçe Çil Çil, Dr. Ogr. Uyesi, Study chair, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449078
- Sponsor's protocol ID
- Abdullah Omar A, PT
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Cognitive Functional Therapy on Pain, Physical Function, and Kinesiophobia in Individuals With Chronic Ankle Sprain
- ClinicalTrials.gov ID
- NCT07449078
- Acronym / sponsor ID
- Abdullah Omar A, PT
- Conditions
- Chronic Ankle Sprain, Chronic Ankle Sprains
- Keywords
- Chronic Ankle Sprain, CAS, CFT, Cognitive Functional Therapy, Behavior, Beliefs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Mar 2026 (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 aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS).
Detailed description
The aim of this study is to investigate the effects of Cognitive Functional Therapy (CFT) on pain, physical function, and kinesiophobia in individuals with chronic ankle sprain (CAS). This study will follow a structured clinical research protocol designed to evaluate the effects of Cognitive Functional Therapy (CFT) on individuals with chronic ankle sprain.
This study is an experimental clinical intervention with a two-time-point measurement design. The Cognitive Functional Therapy (CFT) program will be applied to individuals with chronic ankle sprain, and its effects will be evaluated at baseline (before intervention) and after the 12-week intervention.
The study will take place between January 2026 and June 2026. All participants will undergo an initial eligibility screening by an orthopedic specialist prior to enrollment. Following informed consent, eligible participants will attend a baseline assessment session, complete validated self-report questionnaires, and then begin a 12-week individualized CFT program consisting of seven sessions. Interventions will be delivered by a trained physiotherapist with clinical experience in musculoskeletal rehabilitation and certification in CFT principles. All data collection, including digital files and paper records, will be securely stored in encrypted systems accessible only to the research team. At the conclusion of the 12-week program, participants will fill the same questionnaires they filled at the beginning of the study as an outcome measurement.
The outcome measurements are VAS, TSK-17, and FAAM questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Functional Therapy Group | Experimental | Procedure: Cognitive Functional TherapyCognitive Functional Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ongoing pain or swelling, "giving way" episodes, and re-injury during sports or daily activity
- Adults aged 18-65 years
- History of lateral ankle sprain with symptoms persisting for more than 3 months
- Continuing symptoms such as pain, instability, or activity limitations
- Ability to understand and communicate in English or Arabic
Key exclusion criteria (6 listed)
- History of ankle surgery within the past 12 months
- Advanced ankle osteoarthritis or systemic inflammatory, neurological, or vestibular conditions
- Currently undergoing physiotherapy for the same condition
- Cognitive impairment or severe psychological disorder that could interfere with participation
- Pregnancy or planned pregnancy during the study period
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 |
|---|---|---|
| Cognitive Functional TherapyCognitive Functional Therapy is an integrated behavioral approach for individualizing the management of people with chronic pain, originally developed for Low Back Pain Patients. It uses a multidimensional "clinical reasoning framework" to identify key modifiable targets for management on the basis of careful listening to the individual's story and examining the individual's behavioral responses to pain. This approach enables the treating clinician to take individuals on a journey to effectively self-manage their chronic pain with a program that is tailored to their unique clinical presentation and context. | Procedure or surgery | Cognitive Functional Therapy Group |
Primary outcome
FAAM
Time frame: 12 Weeks
Foot and Ankle Ability Measure
TSK-17
Time frame: 12 Weeks
Tampa Scale of Kinesiophobia
VAS
Time frame: 12 Weeks
Visual Analogue Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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.
Abdullah Omar Alwakil, Bachelor principal investigator
Yeditepe University
Dr. Öğr. Üyesi Elif Tuğçe Çil Çil, Dr. Ogr. Uyesi study chair
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Functional Therapy in people with Chronic Ankle Sprain and Chronic Ankle Sprains, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Omar A PT, MSc (0090 531 699 4226, abdullah.alwakil@std.yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAAM (time frame: 12 Weeks). 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 4 Mar 2026.