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Recruiting NCT07449078

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

No phase Interventional Chronic Ankle Sprain Chronic Ankle Sprains

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Functional Therapy.
Who it may be relevant to
Registry conditions: Chronic Ankle Sprain, Chronic Ankle Sprains. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • FAAM [Time frame: 12 Weeks]
  • TSK-17 [Time frame: 12 Weeks]
  • VAS [Time frame: 12 Weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Yeditepe University — Istanbul

Identifiers

NCT: NCT07449078 · Abdullah Omar A, PT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗