Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy

Recruiting now · Not applicable

Conditions studied: Diabetic Peripheral Neuropathy, Diabetes Mellitus

In brief

This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN). The primary goals are to evaluate: * Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN * Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN The participants will be required to complete * Questionnaires * Clinical examination * 3-Dimensional gait analysis on an instrumented treadmill * Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking

Key facts

Study ID

NCT06591780

Run by

Florida Institute for Human and Machine Cognition

People needed

25

Starts

2025-10-20

Expected to finish

2027-06-01

Last updated by the study team

2026-03-11

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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