Cognitive Behavioral Based Physical Therapy for Patients With Chronic Ankle Instability

NCT07237581 | Completed

• 1 other identifier: 2003479
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Sprains; Chronic Ankle Instability

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Change from baseline center of force anterior-posterior excursion balance (cm)

  3 weeks

• Change from baseline center of force left-right excursion balance (cm)

  3 weeks

• Change from baseline foot and ankle muscle strength (Newtons)

  3 weeks

• Change from baseline center of force total area (cm^2)

  3 weeks

Study Arms (2)

CBPT/HEP Group

EXPERIMENTAL

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

HEP Only Group

ACTIVE COMPARATOR

Participants receive 3 weeks of a home exercise physical therapy program, consisting of flexibility, foot and ankle strengthening, and balance exercises.

Behavioral: HEP Only

Interventions

CBPT/HEP BEHAVIORAL

6 sessions of CBPT program and 3 weeks HEP

CBPT/HEP Group

HEP Only BEHAVIORAL

3 weeks HEP

HEP Only Group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Rehabilitation Science Research Lab

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: investigators involved in participant screening, outcome measures, and intervention administration
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: November 20, 2025
• Study Start: April 14, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)