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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Florida Institute for Human and Machine Cognition
RECRUITING
Pensacola
Contact Information
Primary
Nicole K Rendos, PhD
nrendos@ihmc.org
(404) 202-4442
Backup
Craig Tuggle
ctuggle@ihmc.org
850-202-4462
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 25
Treatments
Experimental: Real-Time Biofeedback Walking Trials
Real-time biofeedback of propulsion and plantar pressure to measure the immediate effects of biofeedback on walking function and gait mechanics.~Permuted block randomization (blocks of 4) will be used to allocate the order of the biofeedback stimulus (plantar pressure-intervention A or propulsion-intervention B).~Participants will receive both interventions in session 3, but the order will be randomized.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Florida Institute for Human and Machine Cognition

This content was sourced from clinicaltrials.gov