Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Who can join
Ages 45 to 90 · All sexes
Full eligibility 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
About the study
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
What is being tested
- Clinical Evaluation (other)
- Plantar Pressure Biofeedback Gait Training (other)
- Propulsion Biofeedback Gait Training (other)
Sponsor: Florida Institute for Human and Machine Cognition · Participants: 25 · Started: Oct 20, 2025
Contact the study team
- Nicole K Rendos, PhD · Phone: (404) 202-4442
- Craig Tuggle · Phone: 850-202-4462
Official record on ClinicalTrials.gov — NCT06591780
Locations in the U.S.
| Florida | Florida Institute for Human and Machine Cognition, Pensacola |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.