An interventional study of Clinical Evaluation and Plantar Pressure Biofeedback Gait Training in Diabetic Peripheral Neuropathy and Diabetes Mellitus, sponsored by Florida Institute for Human and Machine Cognition. Recruiting at 1 site in United States. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Florida Institute for Human and Machine Cognition · Not applicable, Interventional, and Basic science
This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN).
The primary goals are to evaluate:
The participants will be required to complete
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.
Exclusion Criteria:
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
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.
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
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
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.
Time frame: 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.
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
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.
Time frame: 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.
Time frame: 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.
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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Florida Institute for Human and Machine Cognition