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Recruiting NCT06591780

NCT06591780 Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy

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Clinical Trial Summary
NCT ID NCT06591780
Status Recruiting
Phase
Sponsor Florida Institute for Human and Machine Cognition
Condition Diabetic Peripheral Neuropathy
Study Type INTERVENTIONAL
Enrollment 25 participants
Start Date 2025-10-20
Primary Completion 2027-06-01

Trial Parameters

Condition Diabetic Peripheral Neuropathy
Sponsor Florida Institute for Human and Machine Cognition
Study Type INTERVENTIONAL
Phase N/A
Enrollment 25
Sex ALL
Min Age 45 Years
Max Age 90 Years
Start Date 2025-10-20
Completion 2027-06-01
Interventions
Clinical EvaluationPlantar Pressure Biofeedback Gait TrainingPropulsion Biofeedback Gait Training

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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

Eligibility Criteria

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 med

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