Effects of Gait Retraining With Auditory Feedback (NCT04302961) | Clinical Trial Compass
CompletedEarly Phase 1
Effects of Gait Retraining With Auditory Feedback
United States28 participantsStarted 2020-10-05
Plain-language 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. 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from baseline in lower extremity kinetics during walking