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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: nrendos@ihmc.org
• Phone: (850) 202-4442

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.