- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449078
Investigating the Effects of Cognitive Functional Therapy on Pain, Physical Function, and Kinesiophobia in Individuals With Chronic Ankle Sprain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdullah Omar A PT, MSc
- Phone Number: 0090 531 699 4226
- Email: abdullah.alwakil@std.yeditepe.edu.tr
Study Contact Backup
- Name: Dr. Öğr. Üyesi Elif Tuğçe Çil Elif Tuğçe Çil
- Phone Number: 0090 554 481 10 92
- Email: tugce.cill@gmail.com
Study Locations
-
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Ataşehir
-
Istanbul, Ataşehir, Turkey (Türkiye), 34775
- Recruiting
- Yeditepe University
-
Contact:
- Dr. Öğr. Üyesi Elif Tuğçe Çil Dr. Öğr. Üyesi Elif Tuğçe Çil, Dr. Ogr. Uyesi
- Phone Number: 0090 554 481 10 92
- Email: tugce.cill@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Functional Therapy Group
Cognitive Functional Therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FAAM
Time Frame: 12 Weeks
|
Foot and Ankle Ability Measure
|
12 Weeks
|
|
TSK-17
Time Frame: 12 Weeks
|
Tampa Scale of Kinesiophobia
|
12 Weeks
|
|
VAS
Time Frame: 12 Weeks
|
Visual Analogue Scale
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abdullah Omar Alwakil, Bachelor, Yeditepe University
- Study Chair: Dr. Öğr. Üyesi Elif Tuğçe Çil Çil, Dr. Ogr. Uyesi, Yeditepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abdullah Omar A, PT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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