Improving walking ability in people with diabetic nerve damage using biofeedback
Official title: Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Run by Florida Institute for Human and Machine Cognition · NCT06591780 · Data updated 2026-11-12
This study is testing if using real-time feedback on walking can help people with diabetic nerve damage improve their walking ability and reduce the risk of serious foot problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 90 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Florida Institute for Human and Machine Cognition Academic / other |
| Locations | 1 site (Pensacola, Florida) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT06591780 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with diabetes mellitus and diabetic peripheral neuropathy who can walk independently without assistive devices.
✕Probably not a fit
Patients with severe cognitive or visual impairments, active ulcers, or significant orthopedic issues unrelated to diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance gait performance in individuals suffering from Diabetic Peripheral Neuropathy (DPN) by utilizing innovative biofeedback techniques. Participants will undergo clinical evaluations and 3-Dimensional gait analysis on a treadmill, receiving real-time visual and auditory feedback on their walking mechanics. The study focuses on understanding the biomechanical factors affecting plantar pressure and propulsion during gait, with the goal of developing personalized biofeedback interventions to improve walking function and reduce the risk of complications such as ulcers and amputations.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking ability and quality of life for patients with diabetic peripheral neuropathy.
How similar studies have gone: While the use of biofeedback in rehabilitation is promising, this specific multi-variable approach in the context of diabetic peripheral neuropathy is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to walk 10-meters independently without an assistive device * Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 6 minutes at a self-selected speed * Diagnosis of diabetes mellitus * Diagnosis of diabetic peripheral neuropathy by a physician * Foot examination within the past 6 months documenting ambulatory status * Physician clearance Exclusion Criteria: * History of amputation * Active ulceration * Medial column deformity * Severe cognitive impairment (MoCA \< 10) * Severe visual impairment * History of Charcot osteoarthropathy * History of posterior muscle group lengthening * History of lower extremity joint replacement * History of lower extremity and/or foot surgery affecting walking mechanics * Orthopaedic problems of the lower limbs or spine due to other medical conditions (not diabetes or DPN) that limit walking or cause pain during walking * Improper footwear for walking and community ambulation * Cardiovascular or medical condition affecting ability to walk safely * History of unexplained dizziness or fainting in the past 2 months * Allergy to adhesive tape or rubbing alcohol
Where it's running
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Florida Institute for Human and Machine Cognition
Pensacola, Florida, United States Recruiting
Study contacts
- Principal investigator: Nicole K Rendos, PhD — Florida Institute for Human and Machine Cognition
- Study coordinator: Nicole K Rendos, PhD
- Email: nrendos@ihmc.org
- Phone: (404) 202-4442
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.