Biofeedback Gait Training for Diabetic Neuropathy

Recruiting at 1 trial location

Overseen By Craig Tuggle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Amputation, Ulceration, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 sessions over 2 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving walking in individuals with Diabetic Peripheral Neuropathy (DPN) through biofeedback. The researchers aim to study how guided feedback affects foot pressure and push-off strength during walking. Participants will walk on a treadmill while receiving real-time visual and sound feedback to help adjust their gait. This process is known as Plantar Pressure Biofeedback Gait Training. Individuals diagnosed with diabetes and DPN who can walk 10 meters without assistance may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mobility for those with DPN.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your physician for guidance.

What prior data suggests that this biofeedback gait training is safe for individuals with Diabetic Peripheral Neuropathy?

Studies have shown that biofeedback gait training is safe for people with diabetic peripheral neuropathy. Research indicates that plantar pressure biofeedback can safely reduce foot pressure without causing new problem areas. One study demonstrated a reduction in peak foot pressure from 262 kPa to safer levels in 13 patients.

For propulsion biofeedback, specific safety data is not detailed, but similar biofeedback systems are commonly used to improve walking. These systems assist with balance and even out foot pressure. Overall, research suggests these biofeedback methods are well-tolerated and do not lead to any reported harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the biofeedback gait training for diabetic neuropathy because it offers a unique way to improve walking function and gait mechanics. Traditional treatments for diabetic neuropathy often focus on pain management or medication, but this approach uses real-time biofeedback to directly address how patients walk. By providing immediate feedback on plantar pressure and propulsion, this method helps patients adjust their gait in a way that could lead to better mobility and balance. This innovative use of biofeedback technology has the potential to enhance quality of life for individuals with diabetic neuropathy by targeting the root of mobility issues directly.

What evidence suggests that this biofeedback gait training is effective for diabetic neuropathy?

Research has shown that biofeedback gait training can help people with diabetic peripheral neuropathy (DPN) walk better. In this trial, participants will undergo both Plantar Pressure Biofeedback Gait Training and Propulsion Biofeedback Gait Training. One study with 29 older adults with DPN found that visual feedback helped lower pressure on the front part of the foot, potentially preventing foot injuries. Another study demonstrated that biofeedback and specific exercises improved pressure distribution across the foot, reducing fall risk. For propulsion biofeedback, studies suggest it can enhance walking and reduce foot pressure. Overall, these biofeedback methods appear promising for improving walking and balance in people with DPN. ^{1 3 4 6 7}

Who Is on the Research Team?

Nicole K Rendos, PhD

Principal Investigator

Florida Institute for Human and Machine Cognition

Are You a Good Fit for This Trial?

This trial is for individuals with Diabetic Peripheral Neuropathy, which can lead to foot problems like ulcers. Participants should be able to complete questionnaires, undergo a clinical exam, and perform gait analysis on a treadmill. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have been diagnosed with diabetes.

Physician clearance

I can walk on a treadmill for 6 minutes at my own pace.

Exclusion Criteria

I have severe difficulty seeing.

I currently have an open sore that is not healing.

Severe cognitive impairment (MoCA < 10)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete questionnaires, clinical examination, and 3-D gait analysis

1 session

1 visit (in-person)

Treatment

Participants receive real-time biofeedback on propulsion and plantar pressure during walking

3 sessions over 2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in gait mechanics and biomechanics post-treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plantar Pressure Biofeedback Gait Training
• Propulsion Biofeedback Gait Training

Trial Overview The study tests how biofeedback training affects walking in people with diabetic nerve damage in their feet. It uses visual and auditory cues to help improve plantar pressure (how the foot presses on the ground) and propulsion (how the foot pushes off).

How Is the Trial Designed?

Group I: Real-Time Biofeedback Walking Trials Experimental Treatment 3 Interventions

Real-time biofeedback of propulsion and plantar pressure to measure the immediate effects of biofeedback on walking function and gait mechanics. Permuted block randomization (blocks of 4) will be used to allocate the order of the biofeedback stimulus (plantar pressure-intervention A or propulsion-intervention B). Participants will receive both interventions in session 3, but the order will be randomized.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Florida Institute for Human and Machine Cognition

Lead Sponsor

Trials

6

Recruited

540+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A new biofeedback-based method significantly reduced peak plantar pressure in 13 diabetic patients with peripheral neuropathy, showing a decrease from 262 kPa to 191 kPa after training, which is crucial for preventing foot ulcers.

The positive effects of this training persisted even 10 days after the initial learning period, suggesting that this method could effectively promote foot offloading in at-risk patients, although further research is needed to confirm long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback for foot offloading in diabetic patients with peripheral neuropathy. Pataky, Z., de León Rodriguez, D., Allet, L., et al.[2010]

Task-Oriented gait training significantly improved gait biomechanics in 14 patients with Diabetes Neuropathy over 12 weeks, enhancing vertical and horizontal ground reaction forces and reducing the risk of falling.

Participants showed improved confidence in daily activities and better muscle timing and coordination, as evidenced by decreased Time Get up and Go scores and increased Fall Efficacy Scale-International scores after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Task-Oriented Motor Training on gait characteristics of patients with type 2 diabetes neuropathy. Salsabili, H., Bahrpeyma, F., Esteki, A.[2020]

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]

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]

A new walking strategy learned through biofeedback significantly reduced peak plantar pressure (PPP) in at-risk zones for diabetic patients, with measurements showing a decrease from 242 kPa at baseline to 165 kPa after training.

The biofeedback method was effective and safe, as it did not create new areas of high pressure on the feet, indicating a balanced pressure distribution during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback can reduce foot pressure to a safe level and without causing new at-risk zones in patients with diabetes and peripheral neuropathy. De León Rodriguez, D., Allet, L., Golay, A., et al.[2013]

In a study involving 29 older adults with diabetic peripheral neuropathy, visual feedback significantly reduced peak plantar pressures in the forefoot area immediately after training, but this effect did not persist long-term (1 week).

Despite initial improvements, participants were unable to maintain the new gait pattern to reduce plantar pressures over time, indicating that visual feedback alone may not be sufficient for long-term gait adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor learning of a gait pattern to reduce forefoot plantar pressures in individuals with diabetic peripheral neuropathy. York, RM., Perell-Gerson, KL., Barr, M., et al.[2019]

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]

A plantar pressure-based biofeedback system was developed and validated for improving ankle muscle recruitment in individuals with cerebral palsy, showing significant increases in muscle activation during walking without the complexities of EMG systems.

Both the EMG-based and plantar pressure-based systems effectively enhanced muscle activation in the soleus and gastrocnemius muscles, indicating that the new system could be a viable, low-cost alternative for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Under pressure: design and validation of a pressure-sensitive insole for ankle plantar flexion biofeedback during neuromuscular gait training. Conner, BC., Fang, Y., Lerner, ZF.[2023]

Citations

1. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-8-2023-dc3be

Biofeedback Gait Training for Diabetic Peripheral Neuropathy In a study involving 29 older adults with diabetic peripheral neuropathy, visual feedback significantly reduced peak plantar pressures in the forefoot area ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167735/

Impact of Exercise Training in Patients with Diabetic ... Strength-based exercise interventions showed improvements in static and dynamic balance, neuropathic signs and symptoms, strength, and foot ...

3. ctv.veeva.com ctv.veeva.com/study/walking-function-in-diabetic-peripheral-neuropathy

Walking Function in Diabetic Peripheral Neuropathy Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-13-36

Effects of a combined strengthening, stretching and functional ... The main outcome is plantar pressure during foot rollover, and the secondary outcomes are kinetic and kinematic parameters of gait, neuropathy ...

5. jneuroscience.com jneuroscience.com/?smd_process_download=1&download_id=1279

Improving Planter Pressure Distribution Could Reduce the ... Biofeedback and task specific training led to decreased risk of fall by improving planter pressure distribution.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23081857/

Biofeedback can reduce foot pressure to a safe level and ... The foot off-loading by biofeedback leads to a safe and regular plantar pressure distribution without inducing any new 'at-risk' area under both feet.

7. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-9-2024-3a3ee

Biofeedback Gait Training for Diabetic Neuropathy A new biofeedback-based method significantly reduced peak plantar pressure in 13 diabetic patients with peripheral neuropathy, showing a decrease from 262 kPa ...