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Walking Function in Diabetic Peripheral Neuropathy

Sponsor: Florida Institute for Human and Machine Cognition • ClinicalTrials.gov ID: NCT05965336

Registry updated: 2026-08-18

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Description

The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.

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 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.
Evaluation of Passive Ankle Stiffness (Other)
Participants will be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. EMG activity will be recorded from lower limb muscles (gastrocnemius, soleus, tibialis anterior) during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness (i.e., active + passive) at a fixed activation. In three additional trials, the dynamometer will move the ankle joint through the same motion without active subject resistance and the same analytical procedures will derive passive ankle joint stiffness.
Gait Biomechanics (Other)
Three-dimensional gait analysis is performed as participants walk at a self-selected speed on an instrumented treadmill. Reflective markers are attached to lower extremity segments. Elastic bands are wrapped around the thighs, calves, and pelvis to which small, thermoplastic shells containing reflective markers are attached. Additional markers are taped to the participant's shoes and on the upper back, shoulder, hip, knee, and ankle joints with adhesive skin tape. Marker data is collected using a 7-camera motion analysis system (Vicon Inc., USA). Vicon motion analysis cameras will collect the location of the retroreflective markers in Vicon Nexus software.
Gait Biofeedback (Other)
Audio-visual biofeedback will be 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 will represent the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target will be provided using the heat map colors of red and target line on the bar graph. For propulsion biofeedback, a visual display with a marker will represent the current propulsion (peak AGRF) and a target provided to modulate propulsion. The plantar pressure and AGRF measurements from the participant's baseline walking trials will be used to determine customized biofeedback targets.
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.
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.

Eligibility criteria

Inclusion Criteria for All Participants: 1. Age 45+ years 2. Able to walk 10-meters independently without an assistive device 3. Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed Inclusion Criteria for Participants with DPN: 1. Diagnosis of DM 2. Diagnosis of DPN by a physician 3. Foot examination within the past 6 months to document ambulatory status 4. Physician's clearance Exclusion Criteria for Healthy Able-Bodied Individuals: 1. History of neurologic disease 2. History of orthopaedic disease affecting the lower extremities 3. History of injury or pain affecting the lower extremity or walking function within the past 6 months Exclusion Criteria for All Participants: 1. History of amputation 2. Active ulceration 3. Medial column deformity 4. History of Charcot osteoarthropathy 5. History of posterior muscle group lengthening 6. History of lower extremity joint replacement 7. History of lower extremity and/or foot surgery affecting walking mechanics 8. Orthopaedic problems of the lower limbs or spine due to other medical conditions (not DM or DPN) that limit walking or cause pain during walking 9. Improper footwear for walking and community ambulation 10. Cardiovascular or medical condition affecting ability to walk safely 11. History of unexplained dizziness or fainting in the past 2 months 12. Allergy to adhesive tape or rubbing alcohol 13. Individuals who are pregnant, prisoners, or not yet adults 14. Inability to communicate with the investigators 15. Inability to provide written informed consent

Conditions

Diabetic Peripheral Neuropathy

Locations

Florida Institute for Human and Machine Cognition — Pensacola, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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