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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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 plant
• Другое 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

Первичные конечные точки

• Biomechanical plantar pressure [Срок оценки: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)]
• Biomechanical Propulsion [Срок оценки: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)]

Вторичные конечные точки (3)

• Changes induced by biofeedback in plantar pressure [Срок оценки: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)]
• Changes induced by biofeedback in propulsion [Срок оценки: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)]
• Changes induced by biofeedback in biomechanics during gait [Срок оценки: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Florida Institute for Human and Machine Cognition — Pensacola

Идентификаторы

NCT: NCT06591780 · IRB-2025-0002.1 · P30DK111024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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