Cognitive Behavioral Based Physical Therapy for Patients With Chronic Ankle Instability

November 17, 2025 updated by: Abbis Jaffri, Creighton University

Cognitive Behavioral Based Physical Therapy to Improve Functional Outcomes in Patients With Chronic Ankle Instability: a Pilot Randomized Control Trial

The purpose of this study is to investigate the feasibility of a psychologically informed physical therapy intervention in individuals with Chronic Ankle Instability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project will target the psychological impairments in addition to pathomechanical and motor behavior impairment in individuals with Chronic Ankle Instability, using a cognitive behavioral based physical therapy approach. All participants will first complete a baseline assessment, then will be randomly assigned to treatment groups (CBPT/home exercise program (HEP) or HEP only) using a random number generator by an investigator not involved in participant screening, outcome measures, or intervention administration. Individuals in the CBPT/HEP group will participate in six sessions of 45 minutes each for three weeks (two sessions a week). After three weeks, a post-assessment will be completed for both groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Rehabilitation Science Research Lab

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of at least one ankle sprain (initial sprain at least 1 year prior to participation)
  • Reported foot and ankle ability measure-sports scale (FAAM-sport) <85, identification of functional ankle instability (IdFAI) >10

Exclusion Criteria:

  • History of other lower extremity fracture or surgery
  • Ankle sprain within the past 6-weeks
  • Any conditions known to affect balance
  • Pregnancy
  • Any neurological or psychological problems
  • Individuals already participating in rehabilitation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBPT/HEP Group
Participants receive six sessions (45 minutes each) of a CBPT program, consisting of behavioral self-management, problem solving, cognitive restructuring, and relaxation training. Participants also receive 3 weeks of a home exercise physical therapy program, consisting of flexibility, foot and ankle strengthening, and balance exercises.
Behavioral: CBPT/HEP
6 sessions of CBPT program and 3 weeks HEP
Active Comparator: HEP Only Group
Participants receive 3 weeks of a home exercise physical therapy program, consisting of flexibility, foot and ankle strengthening, and balance exercises.
Behavioral: HEP Only
3 weeks HEP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Prescribed Sessions Attended per Subject
Time Frame: 3 weeks
At least 85% of subjects must complete follow-up testing. A subject who attends post-intervention visit at 3 weeks has completed the follow-up testing.
3 weeks
Percentage of Subjects Completing All Prescribed Sessions Within 3 Weeks
Time Frame: 3 weeks
At least 80% of subjects must attend all the sessions prescribed. Attendance means the subject has showed up and completed the tasks for the session.
3 weeks
Number of Intervention-Related Serious Adverse Events Per Group Within 3 Weeks
Time Frame: 3 weeks
Adverse events are recorded as unfavorable events in which a subject has unintentional and abnormal signs or symptoms temporarily associated with participation in the intervention. The number of adverse events in the intervention group should be similar to that of the control group and will not exceed three serious adverse events related to the intervention.
3 weeks
Change from baseline kinesiophobia at 3 weeks (post-intervention)
Time Frame: 3 weeks
The Tampa Scale of Kinesiophobia (11-question version), which uses a 4-point Likert scale, will be used to assess fear of movement. Individual item scores range from 1-4. Total score is the sum of all scores. Minimum possible total score is 11 and maximum possible total score is 44. Higher scores indicate a worse outcome or greater fear of movement.
3 weeks
Change from baseline self-efficacy at 3 weeks (post-intervention)
Time Frame: 3 weeks
Self-efficacy will be assessed using the 17-item self-efficacy questionnaire. 17 statements of physical activity are scored from 0-100% according to subject's perceived ability to carry out the tasks in the statement. Total score is the average of all scores. Higher scores represent a better outcome or greater self-efficacy.
3 weeks
Change from baseline health related quality of life at 3 weeks (post-intervention)
Time Frame: 3 weeks
Health related quality of life will be assessed using the Disablement in the Physically Active Scale. Individual scores range from 0-4. Total scores are calculated as a sum of individual scores. 2 sub-scales (physical summary component and mental summary component) are calculated along with a total score. Physical summary component scores range from 0-48. Mental summary component scores range from 0-16. Total scores range from 0-64. Higher scores represent worse outcome or worse health related quality of life.
3 weeks
Change from baseline physical activity at 3 weeks (post-intervention)
Time Frame: 3 weeks
Physical activity will be measured by daily steps recorded using Actigraph activity monitor watches.
3 weeks
Change from baseline foot and ankle range of motion at 3 weeks (post-intervention)
Time Frame: 3 weeks
Foot and ankle range of motion will be measured using clinical goniometry techniques and recorded in the unit of degrees.
3 weeks
Change from baseline dynamic balance at 3 weeks (post-intervention)
Time Frame: 3 weeks
Dynamic balance will be measured using a modified Star Excursion Balance Test and reported as a relative distance (%).
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline center of force anterior-posterior excursion balance (cm)
Time Frame: 3 weeks
Measurements will be taken using a Tekscan pressure mat in a single-leg balance test and recorded in units of cm.
3 weeks
Change from baseline center of force left-right excursion balance (cm)
Time Frame: 3 weeks
Measurements will be taken using a Tekscan pressure mat in a single-leg balance test and recorded in units of cm.
3 weeks
Change from baseline foot and ankle muscle strength (Newtons)
Time Frame: 3 weeks
Foot and ankle muscle strength will be measured using hand held dynamometry and reported in units of Newtons.
3 weeks
Change from baseline center of force total area (cm^2)
Time Frame: 3 weeks
Center of force will be measured using a Tekscan pressure mat in a single-leg balance test and recorded in units of cm^2.
3 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Creighton 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2003479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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