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

Overview

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

Detailed description

Over 38 million adults in the United States (\~1 in 7) are living with Diabetes Mellitus (DM), of which diabetic peripheral neuropathy (DPN) is the most common complication, affecting more than 50% of individuals with DM. DPN causes both sensory and motor impairments of the foot and ankle, leading to reduced functional mobility and increased ulceration and amputation risk. Propulsion and plantar pressure are two key interrelated gait parameters contributing to walking function and ulceration risk, respectively. Real-time biofeedback is a non-invasive rehabilitation strategy with significant promise for targeting gait impairments by providing the user with quantitative information regarding a targeted performance variable.

In this study, the team will evaluate multi-joint lower extremity biomechanical responses to univariate propulsion and plantar pressure biofeedback. Secondly, the team will use identified biomechanical compensations to propulsion and plantar pressure biofeedback to develop a multi-variable, implicit, individualized visual biofeedback program to improve gait function in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow us to design more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics.

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 plant
• 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

Primary outcome measures

• Biomechanical plantar pressure [Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)]
• Biomechanical Propulsion [Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)]

Secondary outcome measures (3)

• Changes induced by biofeedback in plantar pressure [Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)]
• Changes induced by biofeedback in propulsion [Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)]
• Changes induced by biofeedback in biomechanics during gait [Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Florida Institute for Human and Machine Cognition — Pensacola

Identifiers

NCT: NCT06591780 · IRB-2025-0002.1 · P30DK111024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗