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Completed

NCT Number: NCT07237581

Cognitive Behavioral Based Physical Therapy for Patients With Chronic Ankle Instability

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

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Key information

Conditions

Ankle Sprains Ankle Injuries Chronic Ankle Instability Leg Injuries Wounds and Injuries

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Science Research Lab

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CBPT/HEP

Behavioral

6 sessions of CBPT program and 3 weeks HEP

HEP Only

Behavioral

3 weeks HEP

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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 (%).

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

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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