Ankle InjuriesEarly Phase 1NCT04302961
Effects of Gait Retraining With Auditory Feedback
A Early Phase 1 study testing Auditory Feedback and No 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
There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. 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?
- Auditory Feedback and No Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 30 Jun 2021
- Phase
- Early Phase 1
- 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
- History of at least one ankle sprain
- Index ankle sprain > 12 months prior to study enrollment
- Most recent ankle sprain > 12 weeks prior to study enrollment
- Score >10 on the Identification of Functional Ankle Instability (IdFAI) survey.
- Score <95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a <85% on the Sport subscales
- Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week.
Who cannot join
- History of ankle surgery
- History of other musculoskeletal injuries within the past 6 weeks
- Any condition affecting plantar pressure distribution
- Neurological or vestibular disorders affecting balance
- 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: Effects of Gait Retraining With Auditory Feedback on Biomechanics and Ankle Joint Health in Individuals With Chronic Ankle Instability
There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.
- Conditions
- Ankle Injuries, Ankle Inversion Sprain
- Being tested
- Auditory 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.
Auditory FeedbackOther
Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.
No FeedbackOther
Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.
| Study group | Role | What they receive |
|---|---|---|
| Auditory Feedback | Experimental | Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback. Receives: Other: Auditory Feedback |
| No Feedback | Active comparator | Participants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving 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 kinetics during walking
Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system
Measured: Immediate post-intervention, 1-week post-intervention
Changes from baseline in talar cartilage deformation before and after walking
Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging system
Measured: Immediate post-intervention, 1-week 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-week post-intervention
Secondary outcomes (2)
Changes from baseline in static balance
Static balance will be measured via a force plate
Measured: Immediate post-intervention, 1-week post-intervention
2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down
Plantar pressure during forward lunges, lateral hops, and a step-down will be recorded with an in-shoe insole system.
Measured: Immediate post-intervention, 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start5 Oct 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 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
- NCT04302961
- Sponsor's protocol ID
- 19-0552
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2020
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torp DM, Thomas AC, Hubbard-Turner T, Donovan L. Plantar pressure profile during walking is associated with talar cartilage characteristics in individuals with chronic ankle instability. Clin Biomech (Bristol). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.
PubMed 35504121
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
- Effects of Gait Retraining With Auditory Feedback on Biomechanics and Ankle Joint Health in Individuals With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04302961
- Acronym / sponsor ID
- 19-0552
- Conditions
- Ankle Injuries, Ankle Inversion Sprain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Mar 2020 (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.
There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory Feedback | Experimental | Other: Auditory FeedbackParticipants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback. |
| No Feedback | Active comparator | Other: No FeedbackParticipants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving feedback. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- History of at least one ankle sprain
- Index ankle sprain > 12 months prior to study enrollment
- Most recent ankle sprain > 12 weeks prior to study enrollment
- Score >10 on the Identification of Functional Ankle Instability (IdFAI) survey.
- Score <95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a <85% on the Sport subscales
Key exclusion criteria (5 listed)
- History of ankle surgery
- History of other musculoskeletal injuries within the past 6 weeks
- Any condition affecting plantar pressure distribution
- Neurological or vestibular disorders affecting balance
- Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
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 |
|---|---|---|
| Auditory FeedbackParticipants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise. | Other | Auditory Feedback |
| No FeedbackParticipants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics. | Other | No Feedback |
Primary outcome
Changes from baseline in lower extremity kinetics during walking
Time frame: Immediate post-intervention, 1-week post-intervention
Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system
Changes from baseline in talar cartilage deformation before and after walking
Time frame: Immediate post-intervention, 1-week post-intervention
Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging system
Changes from baseline in self-reported ankle function
Time frame: Immediate post-intervention, 1-week 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).
2 secondary outcomes
Changes from baseline in static balance
Time frame: Immediate post-intervention, 1-week post-intervention
2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down
Time frame: Immediate post-intervention, 1-week 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.
- Derived from this study: PubMed 35504121Torp DM, Thomas AC, Hubbard-Turner T, Donovan L. Plantar pressure profile during walking is associated with talar cartilage characteristics in individuals with chronic ankle instability. Clin Biomech (Bristol). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.
- 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 Early Phase 1 study testing Auditory Feedback and No 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 6 inclusion and 5 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 kinetics during walking (time frame: Immediate post-intervention, 1-week post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302961, which also lists 1 linked publication.
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.