NCT07449078

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Chronic Ankle SprainCASCFTCognitive Functional TherapyBehaviorBeliefs

Outcome Measures

Primary Outcomes (3)

  • FAAM

    Foot and Ankle Ability Measure

    12 Weeks

  • TSK-17

    Tampa Scale of Kinesiophobia

    12 Weeks

  • VAS

    Visual Analogue Scale

    12 Weeks

Study Arms (1)

Cognitive Functional Therapy Group

EXPERIMENTAL

Cognitive Functional Therapy

Procedure: Cognitive Functional Therapy

Interventions

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.

Cognitive Functional Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34775, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

  • Abdullah Omar Alwakil, Bachelor

    Yeditepe University

    PRINCIPAL INVESTIGATOR
  • Dr. Öğr. Üyesi Elif Tuğçe Çil Çil, Dr. Ogr. Uyesi

    Yeditepe University

    STUDY CHAIR

Central Study Contacts

Dr. Öğr. Üyesi Elif Tuğçe Çil Elif Tuğçe Çil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

January 6, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations