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NCT Number: NCT07449078

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University

Istanbul, Ataşehir, 34775, Turkey (Türkiye)

Location status: Recruiting

Location contact

Dr. Öğr. Üyesi Elif Tuğçe Çil Dr. Öğr. Üyesi Elif Tuğçe Çil, Dr. Ogr. Uyesi

CONTACT

[email protected]

0090 554 481 10 92

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). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Functional Therapy

Procedure

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.

Primary outcomes

  1. FAAM

    Time frame: 12 Weeks

    Foot and Ankle Ability Measure

  2. TSK-17

    Time frame: 12 Weeks

    Tampa Scale of Kinesiophobia

  3. VAS

    Time frame: 12 Weeks

    Visual Analogue Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah Omar A PT, MSc

CONTACT

[email protected]

0090 531 699 4226

Dr. Öğr. Üyesi Elif Tuğçe Çil Elif Tuğçe Çil

CONTACT

[email protected]

0090 554 481 10 92

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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