Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Biomechanical plantar pressure
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Clinical Evaluation (Other)
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.
干预措施: Plantar Pressure Biofeedback Gait Training (Other)
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.
干预措施: Propulsion Biofeedback Gait Training (Other)
结局指标
主要结局
Biomechanical plantar pressure
时间窗: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
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.
Biomechanical Propulsion
时间窗: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
次要结局
- Changes induced by biofeedback in plantar pressure(Study Session 3 (occurs 24 hours up to 2 weeks after Session 3))
- Changes induced by biofeedback in propulsion(Study Session 3 (occurs 24 hours up to 2 weeks after Session 3))
- Changes induced by biofeedback in biomechanics during gait(Study Session 3 (occurs 24 hours up to 2 weeks after Session 3))
研究者
Nicole Rendos
Research Scientist
Florida Institute for Human and Machine Cognition