Biofeedback Gait Training for Diabetic Peripheral Neuropathy

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.

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

The available research shows that Biofeedback Gait Training can help people with diabetic peripheral neuropathy by teaching them a new way to walk that reduces pressure on their feet. This is important because too much pressure can lead to foot ulcers, which are common in people with this condition. One study found that using biofeedback to learn a new walking strategy helped lower foot pressure to safer levels without creating new problem areas. Another study highlighted that biofeedback can improve walking patterns by using rhythmic cues, which helps people walk more evenly and with less effort. Overall, these studies suggest that Biofeedback Gait Training is a promising treatment for improving walking and reducing foot pressure in people with diabetic peripheral neuropathy. ^{1 2 3 4 5}

What safety data exists for biofeedback gait training?

The research provided does not directly address safety data for biofeedback gait training. However, it suggests that biofeedback is used in various contexts, such as improving gait asymmetries, reducing ankle inversion, and enhancing propulsion in post-stroke individuals. These studies focus on the effectiveness and biomechanical outcomes rather than safety. For specific safety data, further research or clinical trial results would be needed. ^{1 3 6 7 8}

Is Gait Biofeedback a promising treatment for people with diabetic peripheral neuropathy?

Yes, Gait Biofeedback is a promising treatment for people with diabetic peripheral neuropathy. It helps reduce foot pressure, which is important for healing and preventing foot ulcers. It also improves nerve function, muscle activation, and foot movement, making walking safer and more comfortable. ^{1 2 9 10 11}

Research Team

Nicole Rendos, PhD

Principal Investigator

Assistant Professor

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

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 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]

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 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 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]

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]

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 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]

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]

References

1. 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]

2. 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]

3. 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]

4. Brazil 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. [2023]

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

The use of biofeedback for gait retraining: A mapping review. [2019]

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

Haptic biofeedback induces changes in ankle push-off during walking. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. [2019]

9. Greece 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. [2021]

10. Switzerland 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

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