Cognitive Behavioral Based Physical Therapy for Patients With Chronic Ankle Instability

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: Completed
• Conditions: Chronic Ankle Instability; Ankle Sprains
• Intervention / Treatment: Behavioral: CBPT/HEP; Behavioral: HEP Only

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: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Prescribed Sessions Attended per Subject	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	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	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)	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)	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)	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)	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)	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)	Dynamic balance will be measured using a modified Star Excursion Balance Test and reported as a relative distance (%).	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline center of force anterior-posterior excursion balance (cm)	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)	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)	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)	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

• Sponsor: Creighton University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID 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