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

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

Conditions

• Diabetic Peripheral Neuropathy
• Diabetes Mellitus

Interventions

OTHER

Clinical Evaluation

A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function. Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and a 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.

OTHER

Plantar Pressure Biofeedback Gait Training

Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target

OTHER

Propulsion Biofeedback Gait Training

Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant\'s immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Florida Institute for Human and Machine Cognition

  lead OTHER

Principal Investigators

• Nicole K Rendos, PhD · Florida Institute for Human and Machine Cognition

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-20

Primary Completion

2027-06-01

Completion

2027-06-01

Countries

• United States

Study Locations