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

NCT06591780 | Recruiting

• 2 other identifiers: IRB-2025-0002.1P30DK111024
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus; Diabetic Peripheral Neuropathy

Keywords

anterior ground reaction force; biofeedback-induced changes in plantar pressure; diabetic peripheral neuropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes induced by biofeedback in plantar pressure

  Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)

• Changes induced by biofeedback in propulsion

  Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)

• Changes induced by biofeedback in biomechanics during gait

  Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)

Study Arms (1)

Real-Time Biofeedback Walking Trials

EXPERIMENTAL

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: Clinical Evaluation; Other: Plantar Pressure Biofeedback Gait Training; Other: Propulsion Biofeedback Gait Training

Interventions

Clinical Evaluation OTHER

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.

Real-Time Biofeedback Walking Trials

Plantar Pressure Biofeedback Gait Training OTHER

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

Also known as: Intervention A

Real-Time Biofeedback Walking Trials

Propulsion Biofeedback Gait Training OTHER

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.

Also known as: Intervention B

Real-Time Biofeedback Walking Trials

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Florida Institute for Human and Machine Cognition: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Florida Institute for Human and Machine Cognition

Pensacola, Florida, 32502, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicole K Rendos, PhD

  Florida Institute for Human and Machine Cognition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole K Rendos, PhD

CONTACT

(404) 202-4442; nrendos@ihmc.org

Craig Tuggle

CONTACT

850-202-4462; ctuggle@ihmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)