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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: Propulsion Biofeedback Gait Training; Other: Clinical Evaluation; Other: Plantar Pressure Biofeedback Gait Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole K Rendos, PhD; Phone Number: (404) 202-4442; Email: nrendos@ihmc.org
• Study Contact Backup: Name: Craig Tuggle; Phone Number: 850-202-4462; Email: ctuggle@ihmc.org

Study Locations

• United States
  • Florida
    • Pensacola, Florida, United States, 32502
      • Recruiting
      • Florida Institute for Human and Machine Cognition
      • Contact: Nicole K Rendos, PhD; Phone Number: 850-202-4442

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; Other Names: Intervention B; 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 Names: Intervention A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanical plantar pressure	Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.	Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
Biomechanical Propulsion	Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.	Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes induced by biofeedback in plantar pressure	Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized.	Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Changes induced by biofeedback in propulsion	Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion.	Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Changes induced by biofeedback in biomechanics during gait	Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.	Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)

Collaborators and Investigators

• Sponsor: Florida Institute for Human and Machine Cognition
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nicole K Rendos, PhD, Florida Institute for Human and Machine Cognition

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: diabetic peripheral neuropathy; anterior ground reaction force; biofeedback-induced changes in plantar pressure
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB-2025-0002.1; P30DK111024 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data on demographics, medical history, clinical evaluation, questionnaires, walking biomechanics, and plantar pressure data will be collected from individuals (N = 25) with diabetic peripheral neuropathy. Subject-level de-identified data will be preserved and shared in raw and pre-processed forms in ".csv" and ".xlsx" format. Biomechanics data will be processed and saved in ".c3d" formatted files as per standard practice in the field of biomechanics.
• IPD Sharing Time Frame: All data will be deposited 6 months following the completion of the study. At a minimum, the data will be made available for 3 years after the completion of the study.
• IPD Sharing Access Criteria: Raw and pre-processed data will be archived through the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). Processed biomechanics data will be archived through SimTK. The archived data will be assigned digital object identifiers (DOI). Both NICHD DASH and SimTK are made available through web-accessible repositories at no cost to users.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No