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

Trial Summary

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 data supports the effectiveness of the treatment Auditory 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 activity during walking. This suggests that auditory biofeedback might be effective in improving walking patterns for those with ankle injuries. ^{1 2 3 4 5}

Is biofeedback gait training safe for humans?

Research on biofeedback gait training, including auditory and visual methods, for chronic ankle instability shows no reported safety concerns. These studies focus on improving walking patterns and muscle activity, suggesting the treatment is generally safe for humans. ^{1 2 3 5 6}

How does Auditory Biofeedback Gait Training differ from other treatments for ankle injuries?

Auditory Biofeedback Gait Training is unique because it uses sound cues to help patients adjust their walking patterns, focusing on improving balance and stability by providing real-time feedback on their movements. This approach is different from traditional physical therapy as it directly engages the patient's auditory senses to promote better gait mechanics, which can be particularly beneficial for those with chronic ankle instability. ^{1 3 4 7 8}

What is the purpose of this trial?

The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective: * Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI. * Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI. * Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI. Participants will: * Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig. * Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Within-session and between-session effects of auditory biofeedback training on center of pressure location during gait in patients with chronic ankle instability. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of an auditory biofeedback device on plantar pressure in patients with chronic ankle instability. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effects of biofeedback on biomechanical factors associated with chronic ankle instability: a systematic review with meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Auditory biofeedback in spastic diplegia. [2013]

5. Denmark pubmed.ncbi.nlm.nih.gov

Gait biofeedback and impairment-based rehabilitation for chronic ankle instability. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Gluteal Activity During Gait in Patients With Chronic Ankle Instability Following Rehabilitation: A Randomized Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Use of audio biofeedback to reduce tibial impact accelerations during running. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. [2023]