Cognitive Behavioral Based Physical Therapy for Patients With Chronic Ankle Instability

NCT ID: NCT07237581

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2024-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Ankle Sprains Chronic Ankle Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
investigators involved in participant screening, outcome measures, and intervention administration

Study Groups

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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.

Group Type EXPERIMENTAL

CBPT/HEP

Intervention Type BEHAVIORAL

6 sessions of CBPT program and 3 weeks HEP

HEP Only Group

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

Group Type ACTIVE_COMPARATOR

HEP Only

Intervention Type BEHAVIORAL

3 weeks HEP

Interventions

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CBPT/HEP

6 sessions of CBPT program and 3 weeks HEP

Intervention Type BEHAVIORAL

HEP Only

3 weeks HEP

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Abbis Jaffri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rehabilitation Science Research Lab

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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2003479

Identifier Type: -

Identifier Source: org_study_id

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