Actively Recruiting

Phase Not Applicable
Age: 45Years - 90Years
All Genders
NCT06591780

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

84 weeks

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

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to walk 10 meters independently without using an assistive device
  • Good enough 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 confirmed by a physician
  • Foot examination within the past 6 months showing ambulatory status
  • Physician clearance to participate
Not Eligible

You will not qualify if you...

  • History of amputation
  • Current active foot ulcer
  • Medial column foot deformity
  • Severe cognitive impairment (MoCA score less than 10)
  • Severe visual impairment
  • History of Charcot osteoarthropathy
  • History of posterior muscle group lengthening surgery
  • History of lower limb joint replacement
  • History of lower limb or foot surgery affecting walking mechanics
  • Orthopaedic problems of lower limbs or spine from other medical conditions limiting walking or causing pain
  • Wearing improper footwear for walking and community ambulation
  • Cardiovascular or medical conditions that affect safe walking
  • 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

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Trial Site Locations

Total: 1 location

1

Florida Institute for Human and Machine Cognition

Pensacola, Florida, United States, 32502

Actively Recruiting

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Research Team

N

Nicole K Rendos, PhD

CONTACT

C

Craig Tuggle

CONTACT

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