Ankle InjuriesNCT04131842
External Versus Internal Feedback in Patients With Chronic Ankle Instability
A study testing External focus of attention visual feedback, External focus of attention auditory feedback and Internal focus of attention video feedback in people with Ankle Injuries and Ankle Inversion Sprain, run by University of North Carolina, Charlotte at 1 site in United States.
Trial summary
Although altered biomechanics has been well documented as an impairment associated with chronic ankle instability (CAI), effective interventions targeting biomechanics with long-term outcomes measuring patient-reported outcomes (PROs) are absent. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Injuries, Ankle Inversion Sprain
- What is being tested?
- External focus of attention visual feedback, External focus of attention auditory feedback and Internal focus of attention video feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Characterized as having chronic ankle instability (CAI) by reporting a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI.
- All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
Who cannot join
- Neurological or vestibular disorders affecting balance
- Currently seeking medical care for CAI
- History of ankle surgery
- History of ankle sprain within the past 6 weeks
- History of other musculoskeletal injuries within the past 6 weeks
- Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Versus Internal Feedback on Biomechanics and Self-reported Function in Patients With Chronic Ankle Instability
Although altered biomechanics has been well documented as an impairment associated with chronic ankle instability (CAI), effective interventions targeting biomechanics with long-term outcomes measuring patient-reported outcomes (PROs) are absent. Evidence suggests that external focus of attention (ExFOCUS), internal focus of attention (InFOCUS) feedback, and auditory feedback during movement training can alter biomechanics in other patient populations, with ExFOCUS and auditory enhancing retention of learned biomechanics. Therefore, this randomized controlled trial will determine if a 4-week (12 session) impairment-based rehabilitation program that includes feedback (ExFOCUS or InFOCUS or Auditory) can (1) decrease ankle inversion kinematics and lateral plantar pressure during walking and (2) improve self-reported function.
- Conditions
- Ankle Injuries, Ankle Inversion Sprain
- Being tested
- External focus of attention visual feedback, External focus of attention auditory feedback, Internal focus of attention video feedback, No feedback
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External focus of attention visual feedbackOther
Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.
External focus of attention auditory feedbackOther
Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.
Internal focus of attention video feedbackOther
Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.
No feedbackOther
Patients will receive no feedback during the impairment-based rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| ExFOCUS Visual | Experimental | Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive external focus of attention visual feedback. Receives: Other: External focus of attention visual feedback |
| ExFOCUS Auditory | Experimental | Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive auditory feedback. Receives: Other: External focus of attention auditory feedback |
| InFOCUS Visual | Experimental | Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive internal focus of attention visual feedback via video. Receives: Other: Internal focus of attention video feedback |
| NoFeedback | Active comparator | Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and receive no feedback. Receives: Other: No feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in lower extremity kinematics and kinetics during walking
Ankle, knee, and hip motion and moments during walking measured by a 3D motion capture system and in shoe plantar pressure system
Measured: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Changes from baseline in self-reported ankle function
Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sport questionnaire. Scores range from 100% (no decrease in function) to 0% (complete loss of function).
Measured: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary outcomes (3)
Changes from baseline in ankle range of motion measured in degrees
Four different ankle ranges of motion will be measured
Measured: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Changes from baseline in ankle maximum voluntary isometric strength
Ankle maximum voluntary isometric strength will be measured during four different ankle positions using a hand-held dynamometer.
Measured: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Changes from baseline in static and dynamic balance
Static balance will be measured via a force plate and dynamic balance will be measured using the Star Excursion Balance Test
Measured: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start18 Feb 2020
- 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 InjuriesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Donovan, University of North Carolina, Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131842
- Sponsor's protocol ID
- IRBIS-19-0263
- Status last verified
- Aug 2024
- First submitted
- 16 Oct 2019
- Last updated
- 19 Aug 2024
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Versus Internal Feedback on Biomechanics and Self-reported Function in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04131842
- Acronym / sponsor ID
- IRBIS-19-0263
- Conditions
- Ankle Injuries, Ankle Inversion Sprain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 Oct 2019 (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.
Although altered biomechanics has been well documented as an impairment associated with chronic ankle instability (CAI), effective interventions targeting biomechanics with long-term outcomes measuring patient-reported outcomes (PROs) are absent. Evidence suggests that external focus of attention (ExFOCUS), internal focus of attention (InFOCUS) feedback, and auditory feedback during movement training can alter biomechanics in other patient populations, with ExFOCUS and auditory enhancing retention of learned biomechanics. Therefore, this randomized controlled trial will determine if a 4-week (12 session) impairment-based rehabilitation program that includes feedback (ExFOCUS or InFOCUS or Auditory) can (1) decrease ankle inversion kinematics and lateral plantar pressure during walking and (2) improve self-reported function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ExFOCUS Visual | Experimental | Other: External focus of attention visual feedbackParticipants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive external focus of attention visual feedback. |
| ExFOCUS Auditory | Experimental | Other: External focus of attention auditory feedbackParticipants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive auditory feedback. |
| InFOCUS Visual | Experimental | Other: Internal focus of attention video feedbackParticipants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive internal focus of attention visual feedback via video. |
| NoFeedback | Active comparator | Other: No feedbackParticipants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and receive no feedback. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Characterized as having chronic ankle instability (CAI) by reporting a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI.
- All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
Key exclusion criteria (6 listed)
- Neurological or vestibular disorders affecting balance
- Currently seeking medical care for CAI
- History of ankle surgery
- History of ankle sprain within the past 6 weeks
- History of other musculoskeletal injuries within the past 6 weeks
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 |
|---|---|---|
| External focus of attention visual feedbackPatients will receive external focus of attention visual feedback during the impairment-based rehabilitation program. | Other | ExFOCUS Visual |
| External focus of attention auditory feedbackPatients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program. | Other | ExFOCUS Auditory |
| Internal focus of attention video feedbackPatients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program. | Other | InFOCUS Visual |
| No feedbackPatients will receive no feedback during the impairment-based rehabilitation program. | Other | NoFeedback |
Primary outcome
Changes from baseline in lower extremity kinematics and kinetics during walking
Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Ankle, knee, and hip motion and moments during walking measured by a 3D motion capture system and in shoe plantar pressure system
Changes from baseline in self-reported ankle function
Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sport questionnaire. Scores range from 100% (no decrease in function) to 0% (complete loss of function).
3 secondary outcomes
Changes from baseline in ankle range of motion measured in degrees
Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Changes from baseline in ankle maximum voluntary isometric strength
Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Changes from baseline in static and dynamic balance
Time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
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 19 Aug 2024.
- 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 External focus of attention visual feedback, External focus of attention auditory feedback and Internal focus of attention video feedback in people with Ankle Injuries and Ankle Inversion Sprain, run by University of North Carolina, Charlotte 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 19 Aug 2024. 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?
Changes from baseline in lower extremity kinematics and kinetics during walking (time frame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention). The study lists 2 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 19 Aug 2024.