Actively Recruiting
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Led by Florida Institute for Human and Machine Cognition · Updated on 2026-03-11
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Florida Institute for Human and Machine Cognition
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying gait function in adults with Diabetic Peripheral Neuropathy (DPN), a common complication affecting foot and ankle sensation and movement in people with diabetes. The study aims to understand biomechanical factors that cause abnormal foot pressure and propulsion during walking and to test how real-time biofeedback can change these factors to improve gait in individuals with DPN. Participants will undergo clinical evaluations and 3-dimensional gait analyses on an instrumented treadmill. They will receive two types of biofeedback interventions—plantar pressure and propulsion biofeedback—delivered via visual and auditory cues on a projector screen while walking. The order of these biofeedback interventions will be randomized, and each participant will experience both types during the study sessions. Throughout the study, participants will complete questionnaires, clinical exams, and gait analyses at multiple sessions. Researchers will measure biomechanical plantar pressure and propulsion, as well as changes induced by biofeedback, to assess immediate effects on walking function and gait mechanics. The study includes follow-up assessments occurring 24 hours up to two weeks after each session to capture lasting biomechanical changes.
CONDITIONS
Brief Title
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants complete a clinical evaluation assessing walking function, mobility, lower extremity sensation, quality of life, and foot function.
1 visit (in-person)
Duration - Single session
Participants undergo a dynamometer-based evaluation of passive ankle stiffness and a 3-dimensional gait analysis to evaluate baseline biomechanics.
1 visit (in-person)
Duration - Single session
Participants complete real-time plantar pressure and propulsion biofeedback gait training to measure immediate effects on walking function and biomechanics using individualized audio-visual feedback.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Florida Institute for Human and Machine Cognition
Pensacola, Florida, United States, 32502
Actively Recruiting
Research Team
N
Nicole K Rendos, PhD
C
Craig Tuggle
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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