Biofeedback Gait Training for Diabetic Peripheral Neuropathy

Recruiting at 2 trial locations

Overseen By Nicole Rendos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Amputation, Ulceration, Charcot, others

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

Compensation: Varies

Number of Visits: 9

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with diabetic peripheral neuropathy (DPN), a condition affecting nerve function in those with diabetes, improve their walking patterns. It will test two types of biofeedback gait training, which provide real-time feedback on walking form, to determine their effectiveness in changing and enhancing walking function. Individuals diagnosed with diabetes and DPN who can walk independently without an assistive device may be suitable for this study. Participants will be randomly assigned to begin with either plantar pressure or propulsion biofeedback training and will complete several walking sessions to evaluate the effects. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance walking ability.

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

The trial protocol 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 this gait training is safe for individuals with diabetic peripheral neuropathy?

Research has shown that biofeedback gait training is generally safe for people with diabetic peripheral neuropathy. In one study, biofeedback lowered foot pressure without causing new problems for those with diabetes and nerve issues, reducing existing risks without adding new ones.

For plantar pressure biofeedback, another study found a significant decrease in the highest pressure on the feet among diabetic participants. This suggests the technique effectively reduces pressure and is safe, as no side effects were reported.

However, less direct safety information exists for propulsion biofeedback. Most research focuses on biofeedback's effectiveness in different situations, but no specific safety concerns have been identified for this type of training.

Overall, these findings suggest that both types of biofeedback gait training are well-tolerated and pose minimal risk to participants with diabetic peripheral neuropathy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about biofeedback gait training for diabetic peripheral neuropathy (DPN) because it offers a novel way to improve walking patterns in people affected by this condition. Unlike traditional treatments that focus on medication or physical therapy exercises, this method uses real-time feedback to help patients adjust their walking mechanics. By using sensors to provide immediate information about plantar pressure and propulsion forces, participants can make instant, informed changes to their gait, potentially leading to improved balance and reduced risk of falls. This technique not only empowers patients with immediate insights into their movement but also aims to retain these benefits over time, which could make a significant difference in their daily mobility and quality of life.

What evidence suggests that this trial's gait training treatments could be effective for diabetic peripheral neuropathy?

Research has shown that biofeedback gait training can help people with diabetic peripheral neuropathy (DPN) improve their walking. In this trial, participants will receive either Plantar Pressure Biofeedback Gait Training followed by Propulsion Biofeedback Gait Training, or the reverse order. One study found that visual feedback helped older adults with DPN reduce foot pressure, making walking safer. Another study demonstrated that biofeedback can lower foot pressure without introducing new injury risks. For propulsion biofeedback, studies have shown it can teach a new walking method that reduces foot pressure, with lasting benefits. Both methods hold promise for helping those with DPN walk better and more safely. ^{1 2 3 5 6}

Who Is on the Research Team?

Nicole Rendos, PhD

Principal Investigator

Research Scientist

Are You a Good Fit for This Trial?

This trial is for adults aged 45 and older with diabetic peripheral neuropathy (DPN) who can walk independently without aids. Participants must have a diabetes diagnosis, be able to walk on a treadmill, and have had a foot exam in the last six months. People with certain lower limb conditions, surgeries affecting walking, cardiovascular issues that impact safety while walking, or those pregnant cannot join.

Inclusion Criteria

Physician's clearance

I have been diagnosed with diabetic peripheral neuropathy.

I can walk on a treadmill for 1 minute at my own pace.

Exclusion Criteria

I have had surgery to lengthen muscles in the back of my leg.

I am not pregnant, imprisoned, or under the legal adult age.

You cannot talk to the researchers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation and Baseline Testing

Participants undergo clinical evaluation, gait biomechanics, and gait biofeedback for baseline comparison

1-2 weeks

3 sessions (in-person)

Biofeedback Gait Training

Participants with DPN receive biofeedback gait training focusing on plantar pressure and propulsion

3-4 weeks

4 sessions (in-person)

Follow-up

Participants are monitored for changes in biomechanics and propulsion after training

4 weeks

2 sessions (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gait Biofeedback
• Plantar Pressure Biofeedback Gait Training
• Propulsion Biofeedback Gait Training

Trial Overview The study aims to compare walking function between individuals with DPN and healthy adults. It will test if gait training with biofeedback improves walking patterns in people with DPN. The trial includes clinical evaluations of movement and stiffness as well as specialized gait training sessions.

How Is the Trial Designed?

Group I: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training Experimental Treatment 6 Interventions

Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.

Group II: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training Experimental Treatment 6 Interventions

Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.

Group III: Able-Bodied Participants Active Control 4 Interventions

Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.

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+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A 12-week group-based foot-ankle exercise program for individuals with diabetic neuropathy led to significant improvements in hip extensor moments at push-off and increased hallux contact area, indicating better propulsion during walking.

While the exercise program showed some positive effects on specific aspects of foot-ankle function, it did not significantly change overall lower limb biomechanics or plantar pressure in other areas, suggesting that more intensive or individualized interventions may be necessary for broader improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of foot-ankle exercises on foot-ankle kinematics, plantar pressure, and gait kinetics in people with diabetic neuropathy: Secondary outcomes from a randomized controlled trial. Monteiro, RL., Ferreira, JSSP., Silva, ÉQ., 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]

A 12-week internet-based foot-ankle exercise program for individuals with diabetic peripheral neuropathy (DPN) showed significant improvements in ankle and first metatarsophalangeal joint motion, as well as reduced foot pain and improved foot function after 24 weeks.

The study involved 30 participants and demonstrated good adherence to the exercise program with only mild adverse events, suggesting that this intervention is safe and feasible for enhancing clinical and biomechanical outcomes in DPN patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could an Internet-Based Foot-Ankle Therapeutic Exercise Program Modify Clinical Outcomes and Gait Biomechanics in People with Diabetic Neuropathy? A Clinical Proof-of-Concept Study. Cruvinel-Júnior, RH., Ferreira, JSSP., Veríssimo, JL., et al.[2023]

In a study of 38 patients with diabetic peripheral neuropathy (DPN), an 8-week program of sensorimotor and gait training significantly improved proprioception and nerve function compared to a control group that only received education.

The training also enhanced muscle activation in key areas, such as the medial gastrocnemius and multifidus, during both standing and walking, indicating its potential as an effective intervention for improving physical function in DPN patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensorimotor and gait training improves proprioception, nerve function, and muscular activation in patients with diabetic peripheral neuropathy: a randomized control trial. Ahmad, I., Verma, S., Noohu, MM., et al.[2021]

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 review of 173 studies on biofeedback for improving gait outcomes found that visual feedback was the most commonly used method, but the overall study designs were poor, with only 8% including a control group and retention test.

The findings suggest a need for better-designed studies that directly compare different types of feedback and assess their long-term effects in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of biofeedback for gait retraining: A mapping review. van Gelder, LMA., Barnes, A., Wheat, JS., et al.[2019]

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]

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]

The study involved 20 able-bodied adults and found that haptic biofeedback can influence gait by modulating peak ankle moment and peak ankle power during walking, with significant changes observed in response to feedback conditions.

While participants could increase peak ankle power with feedback to raise ankle moment, they did not successfully increase peak ankle moment itself, indicating that further research is needed to optimize biofeedback strategies for enhancing ankle function during gait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haptic biofeedback induces changes in ankle push-off during walking. Schenck, C., Bakke, D., Besier, T.[2020]

In a study involving nine individuals with post-stroke hemiparesis, real-time biofeedback targeting anterior ground reaction forces (AGRF) significantly improved paretic propulsion during gait, with effects lasting up to 30 minutes post-training.

The biofeedback training was more effective than a control condition without feedback, indicating that this method could be a promising strategy for enhancing walking function in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Genthe, K., Schenck, C., Eicholtz, S., et al.[2019]

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 ... Exercise training appears to have potential benefits for certain aspects of DPN, neuropathic symptoms, and functional capacity. However, the ...

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

Biofeedback can reduce foot pressure to a safe level and ... Biofeedback can reduce foot pressure to a safe level and without causing new at-risk zones in patients with diabetes and peripheral neuropathy.

4. 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 ...

5. 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 ...

6. balimedicaljournal.ejournals.ca balimedicaljournal.ejournals.ca/index.php/bmj/article/download/5122/3286/26951

Immediate effects of gait biofeedback on peak plantar ... 18. Patients with diabetic neuropathy proved that the learning technique using PEDAR-X® results charts regarding plantar pressure in an effort to control ...