Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
NCT ID: NCT06591780
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-08-31
2026-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
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.
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
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.
Interventions
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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.
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
90 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Florida Institute for Human and Machine Cognition
OTHER
Responsible Party
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Nicole Rendos
Research Scientist
Principal Investigators
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Nicole K Rendos, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida Institute for Human and Machine Cognition
Locations
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Florida Institute for Human and Machine Cognition
Pensacola, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Nicole K Rendos, PhD
Role: primary
Other Identifiers
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IRB-2025-0002.1
Identifier Type: -
Identifier Source: org_study_id
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