Ankle SprainsNCT07237581
Cognitive Behavioral Based Physical Therapy for Patients With Chronic Ankle Instability
A study testing CBPT/HEP and HEP Only in people with Ankle Sprains and Chronic Ankle Instability, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the feasibility of a psychologically informed physical therapy intervention in individuals with Chronic Ankle Instability. Read more about this study
- Who is it for?
- Ages 19 to 35 years
- Conditions the study is for
- Ankle Sprains, Chronic Ankle Instability
- What is being tested?
- CBPT/HEP and HEP Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Science Research Lab
Omaha, Nebraska, 68131
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Sprains, Chronic Ankle Instability
- Being tested
- CBPT/HEP, HEP Only
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBPT/HEPBehavioural
6 sessions of CBPT program and 3 weeks HEP
HEP OnlyBehavioural
3 weeks HEP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: HEP Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (%).
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start14 Apr 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbis Jaffri, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237581
- Sponsor's protocol ID
- 2003479
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Based Physical Therapy to Improve Functional Outcomes in Patients With Chronic Ankle Instability: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07237581
- Acronym / sponsor ID
- 2003479
- Conditions
- Ankle Sprains, Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBPT/HEP Group | Experimental | Behavioral: CBPT/HEPParticipants 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. |
| HEP Only Group | Active comparator | Behavioral: HEP OnlyParticipants receive 3 weeks of a home exercise physical therapy program, consisting of flexibility, foot and ankle strengthening, and balance exercises. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBPT/HEP6 sessions of CBPT program and 3 weeks HEP | Behavioural | CBPT/HEP Group |
| HEP Only3 weeks HEP | Behavioural | HEP Only Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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 (%).
4 secondary outcomes
Change from baseline center of force anterior-posterior excursion balance (cm)
Time frame: 3 weeks
Change from baseline center of force left-right excursion balance (cm)
Time frame: 3 weeks
Change from baseline foot and ankle muscle strength (Newtons)
Time frame: 3 weeks
Change from baseline center of force total area (cm^2)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBPT/HEP and HEP Only in people with Ankle Sprains and Chronic Ankle Instability, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Prescribed Sessions Attended per Subject (time frame: 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.