Investigating the Effects of Cognitive Functional Therapy on Pain, Physical Function, and Kinesiophobia in Individuals With Chronic Ankle Sprain

March 3, 2026 updated by: Yeditepe University
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).

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

    • 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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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

  • 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

This is where you will find people and organizations involved with this study.

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

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)

January 6, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

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

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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