Walking and foot-pressure biofeedback for people with diabetic peripheral neuropathy

Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining

This project will test whether real-time biofeedback about foot pressure and push-off can change walking patterns and improve walking function in adults with diabetic peripheral neuropathy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Florida Institute for Human and Machine Cognition (other)
• Locations: 1 site (Pensacola, Florida)
• Trial ID: NCT05965336 on ClinicalTrials.gov

What this trial studies

This interventional study compares walking mechanics between adults with diabetic peripheral neuropathy (DPN) and healthy controls and then uses real-time gait and plantar-pressure biofeedback to attempt to modify walking patterns. Participants complete clinical and biomechanical evaluations including treadmill walking, plantar pressure measurements, and passive ankle stiffness testing. Those with DPN receive supervised biofeedback gait training to target reductions in harmful plantar pressures and to modify propulsion patterns while monitoring safety and tolerability. The study will report feasibility, safety outcomes, and preliminary effects on walking speed, step counts, and plantar pressure distribution.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 or older with physician-diagnosed diabetic peripheral neuropathy who can walk 10 meters independently and have medical clearance to walk on a treadmill.

Not a fit: Patients with active foot ulceration, prior lower-extremity amputation, major foot deformities, Charcot osteoarthropathy, recent lower-extremity surgery, or those unable to walk independently are unlikely to benefit.

Why it matters

Potential benefit: If successful, the approach could lower high plantar pressures, improve walking speed and mobility, and potentially reduce ulceration risk for people with DPN.

How similar studies have performed: Gait biofeedback has shown benefits in other populations, but targeted plantar-pressure biofeedback specifically for DPN is relatively novel and only preliminarily tested.

Eligibility criteria

Inclusion Criteria for All Participants:

1. Age 45+ years
2. Able to walk 10-meters independently without an assistive device
3. Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed

Inclusion Criteria for Participants with DPN:

1. Diagnosis of DM
2. Diagnosis of DPN by a physician
3. Foot examination within the past 6 months to document ambulatory status
4. Physician's clearance

Exclusion Criteria for Healthy Able-Bodied Individuals:

1. History of neurologic disease
2. History of orthopaedic disease affecting the lower extremities
3. History of injury or pain affecting the lower extremity or walking function within the past 6 months

Exclusion Criteria for All Participants:

1. History of amputation
2. Active ulceration
3. Medial column deformity
4. History of Charcot osteoarthropathy
5. History of posterior muscle group lengthening
6. History of lower extremity joint replacement
7. History of lower extremity and/or foot surgery affecting walking mechanics
8. Orthopaedic problems of the lower limbs or spine due to other medical conditions (not DM or DPN) that limit walking or cause pain during walking
9. Improper footwear for walking and community ambulation
10. Cardiovascular or medical condition affecting ability to walk safely
11. History of unexplained dizziness or fainting in the past 2 months
12. Allergy to adhesive tape or rubbing alcohol
13. Individuals who are pregnant, prisoners, or not yet adults
14. Inability to communicate with the investigators
15. Inability to provide written informed consent

Where this trial is running

Pensacola, Florida

• Florida Institute for Human and Machine Cognition — Pensacola, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Nicole Rendos, PhD — Research Scientist
• Study coordinator: Nicole Rendos, PhD

Conditions: Diabetic Peripheral Neuropathy, Diabetes, Biofeedback-induced changes