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

Trial Summary

What is the purpose of this trial?

This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN). The primary goals are to evaluate: * Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN * Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN The participants will be required to complete * Questionnaires * Clinical examination * 3-Dimensional gait analysis on an instrumented treadmill * Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking

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 data supports the idea that Biofeedback Gait Training for Diabetic Neuropathy is an effective treatment?

The available research shows that Biofeedback Gait Training helps reduce foot pressure in people with diabetic neuropathy, which is important for healing foot ulcers and preventing amputations. Studies have shown that this treatment can teach patients a new way of walking that lowers pressure on the feet, and these changes can last for at least a week. This suggests that Biofeedback Gait Training is effective in managing foot pressure and improving walking patterns in diabetic patients. ^{1 2 3 4 5}

What safety data exists for biofeedback gait training in diabetic neuropathy?

The provided research does not directly address safety data for biofeedback gait training specifically in diabetic neuropathy. However, studies on similar biofeedback interventions, such as those for chronic ankle instability, suggest that biofeedback can improve gait biomechanics and patient-reported outcomes without significant adverse effects. This implies a potential for safe application in diabetic neuropathy, but specific safety data for this condition is not detailed in the available research. ^{2 4 5 6 7}

Is Plantar Pressure Biofeedback Gait Training a promising treatment for diabetic neuropathy?

Yes, Plantar Pressure Biofeedback Gait Training is promising because it helps reduce foot pressure, which is important for healing and preventing foot ulcers in people with diabetic neuropathy. It teaches a new way of walking that can be remembered over time, and it uses feedback to improve walking patterns and reduce pressure on the feet. ^{1 2 3 4 8}

Research Team

Nicole K Rendos, PhD

Principal Investigator

Florida Institute for Human and Machine Cognition

Eligibility Criteria

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.

I had a foot exam in the last 6 months that checked my ability to walk.

Physician clearance

Exclusion Criteria

I have severe difficulty seeing.

I currently have an open sore that is not healing.

Severe cognitive impairment (MoCA < 10)

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2013]

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

Motor learning of a gait pattern to reduce forefoot plantar pressures in individuals with diabetic peripheral neuropathy. [2019]

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

Biofeedback for foot offloading in diabetic patients with peripheral neuropathy. [2010]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Under pressure: design and validation of a pressure-sensitive insole for ankle plantar flexion biofeedback during neuromuscular gait training. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of Task-Oriented Motor Training on gait characteristics of patients with type 2 diabetes neuropathy. [2020]