Biofeedback Gait Training for Ankle Injury

Recruiting at 1 trial location

Overseen By Danielle M Torp, PhD, ATC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Kentucky

Disqualifiers: Recent ankle sprain, Surgery, Fracture, Neurological disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests auditory biofeedback gait training, a method using sounds to help individuals with ankle issues walk better. The goal is to determine if this approach can enhance leg movement, protect ankle cartilage, and reduce feelings of instability. Participants will wear special insoles that provide feedback while walking, marching, and running over six weeks. It suits active adults who have sprained their ankle and experienced it "giving way" twice in the last six months. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for ankle stability.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that auditory biofeedback gait training is safe for ankle injury rehabilitation?

Research has shown that sound feedback can aid individuals with ongoing ankle issues. It reduces pressure on specific foot areas and enhances muscle function, indicating improved safety. Other studies have examined walking training programs and found they improve walking ability without causing serious problems.

These studies reported no major side effects, suggesting the treatment is well-tolerated. Since this clinical trial focuses on exercises and sound feedback, it likely poses fewer risks than medication or surgery, making it a safer option for many participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auditory biofeedback gait training for ankle injuries because it offers a new, interactive way to help patients improve their walking patterns. Unlike traditional physical therapy, which often relies on visual cues and therapist guidance, this method uses auditory signals delivered through in-shoe insoles to provide real-time feedback. This innovative approach could enhance a patient's ability to adjust their gait immediately, potentially speeding up recovery and reducing the risk of future injuries.

What evidence suggests that auditory biofeedback gait training is effective for ankle injury?

Research has shown that auditory biofeedback (AudFB) gait training, which participants in this trial may receive, can help people with chronic ankle instability (CAI). Studies have found that this training improves walking by altering leg movements. One study discovered that after just two weeks of AudFB training, participants improved and maintained better movement patterns. Another study suggested that a 6-week program can lead to both short- and long-term walking improvements. AudFB training aims to reduce pressure on certain parts of the foot and enhance muscle control, making it a promising option for those with ankle issues. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic ankle instability (CAI) due to syndesmotic injury or a sprained ankle. Participants should be able to complete gait training sessions and follow-up tests. Specific eligibility criteria are not provided, but typically include age range, health status, and the severity of CAI.

Inclusion Criteria

Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)

Must answer 'yes' to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)

My knee has given way twice in the last 6 months.

Exclusion Criteria

Current participation in a formal ankle joint rehabilitation program

A concussion in the last 12 months

I sprained my ankle in the last 4 weeks or had another leg injury in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 6 weeks of gait training with auditory biofeedback, including 12 sessions of walking, ruck marching, and running.

6 weeks

12 sessions (in-person)

Post-Intervention Testing

Participants complete testing sessions to assess lower extremity biomechanics, talar cartilage deformation, and ankle instability.

Immediately following intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months post-intervention.

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Auditory Biofeedback Gait Training

Trial Overview The study examines if auditory biofeedback (AudFB) during gait training over six weeks can improve walking biomechanics, reduce ankle cartilage damage, and decrease episodes of the ankle giving way in people with CAI compared to a control group without AudFB.

How Is the Trial Designed?

Group I: auditory biofeedback (AudFB) gait training Experimental Treatment 3 Interventions

AudFB group will wear the Loadsol Pros in-shoe insoles with the audible noise emitted from the iOS device

Group II: Control Active Control 3 Interventions

Control group will wear the Loadsol Pros in-shoe insoles, with the auditory biofeedback function disabled

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

Published Research Related to This Trial

Biofeedback training can significantly improve biomechanical parameters in individuals with chronic ankle instability (CAI), including reducing foot inversion and altering pressure distribution during gait, based on a review of 13 studies with 226 participants.

Auditory biofeedback was found to be particularly effective in modifying plantar pressure, suggesting that different types of feedback may have varying impacts on gait mechanics in CAI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of biofeedback on biomechanical factors associated with chronic ankle instability: a systematic review with meta-analysis. Mousavi, SH., Khorramroo, F., Minoonejad, H., et al.[2023]

Rhythmic stimulation, whether through vibrotactile or auditory methods, significantly improves stance time symmetry ratio (STSR) in healthy adults with induced gait asymmetry, suggesting its potential for gait rehabilitation.

Both types of rhythmic stimulation were equally effective in enhancing gait parameters, indicating that either method could be used to aid individuals with mobility impairments in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. Michelini, A., Sivasambu, H., Andrysek, J.[2023]

In a study involving 27 individuals with chronic ankle instability, those who received visual gait biofeedback (GBF) showed a significant reduction in ankle inversion during walking compared to those who did not receive biofeedback (NBF).

The GBF group also reported greater improvements in patient-reported outcomes related to daily activities and sports, indicating that combining visual biofeedback with rehabilitation can enhance recovery in individuals with chronic ankle instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait biofeedback and impairment-based rehabilitation for chronic ankle instability. Koldenhoven, RM., Jaffri, AH., DeJong, AF., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636222000844

Effects of gait training with auditory biofeedback on ... Patients with CAI improved and retained biomechanics after 2-week gait training. Talar cartilage characteristics were not changed after 8-sessions of gait ...

2. trialx.com trialx.com/clinical-trials/listings/299332/auditory-biofeedback-gait-training-individuals-with-chronic-ankle-instability/?&geo_lat=38.0174&geo_lng=-84.4854&radius=10&place=Lexington&user_country=United%20States

Auditory Biofeedback Gait Training Individuals With ... Our central hypothesis is that a 6-week (12 sessions) gait training program with AudFB will lead to short and long-term improvements in walking, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10720076/

Effects of biofeedback on biomechanical factors associated ... Biofeedback may alter the biomechanics of lower extremities in patients with chronic ankle instability (CAI). We aimed to systematically review ...

4. withpower.com withpower.com/trial/phase-ankle-injuries-2-2025-60b97

Biofeedback Gait Training for Ankle Injury Research shows that auditory biofeedback can help people with chronic ankle instability by reducing pressure on certain parts of the foot and improving muscle ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03507803

Study Details | NCT03507803 | Effects of Gait Biofeedback ... Biofeedback about the foot position during walking may help improve gait biomechanics. The purpose is to determine whether a 4-week rehabilitation program that ...

6. mdpi.com mdpi.com/2076-3417/15/4/1688

Integrating Biofeedback in Dynamic Biomechanical Gait ... This study aimed to investigate the dynamic biomechanical characteristics of CAI patients using a gait-training device following a 6-week intervention program.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39136092/

Gait-Training Interventions for Individuals With Chronic ... Conclusions: Gait-training protocols improved some lower extremity biomechanical outcomes in individuals with CAI. Plantar-pressure outcome ...