Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Biomechanical plantar pressure
研究概览
简要总结
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.
详细描述
Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals with DM. Consequences of DPN include reduced sensation and feedback from the foot and lower limb and increased plantar pressures, predisposing patients to ulcers and lower extremity amputation. Individuals with DPN experience decreased quality of life compared with their healthy and non-neuropathic DM peers, and report problems with mobility, daily activities, pain, and discomfort. Additionally, people with DPN display reduced functional ambulation, step counts, and walking speed. Though increases in physical activity and functional capacity have been associated with improvements in quality of life, DPN poses a unique challenge in mitigating risk while pursuing traditional exercise and walking programs.
Traditional gait training programs used to improve walking function may increase ulceration risk, making these interventions unsuitable if not tailored for people with DPN. The goal of this study is to elucidate the underlying biomechanical mechanisms contributing to the inter-relationships between plantar pressure and propulsion in individuals with DPN, and to examine the safety and feasibility of using real-time biofeedback to modify plantar pressure and propulsion during gait.
The aims of this study are to evaluate (1) biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN; (2) biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN and age-similar controls; and (3) the acceptability, feasibility, safety, and preliminary effects of gait training in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow for the design of 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.
Able-bodied participants will complete three experimental sessions and participants with DPN will complete a total of seven experimental sessions. Each session will be approximately 2-3 hours in duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for All Participants:
- •Age 45+ years
- •Able to walk 10-meters independently without an assistive device
- •Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed
- •Inclusion Criteria for Participants with DPN:
- •Diagnosis of DM
- •Diagnosis of DPN by a physician
- •Foot examination within the past 6 months to document ambulatory status
- •Physician's clearance
排除标准
- •for Healthy Able-Bodied Individuals:
- •History of neurologic disease
- •History of orthopaedic disease affecting the lower extremities
- •History of injury or pain affecting the lower extremity or walking function within the past 6 months
- •Exclusion Criteria for All Participants:
- •History of amputation
- •Active ulceration
- •Medial column deformity
- •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 DM 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
- •Individuals who are pregnant, prisoners, or not yet adults
- •Inability to communicate with the investigators
- •Inability to provide written informed consent
研究组 & 干预措施
Able-Bodied Participants
Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
干预措施: Gait Biofeedback (Other)
Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
干预措施: Clinical Evaluation (Other)
Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
干预措施: Plantar Pressure Biofeedback Gait Training (Other)
Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
干预措施: Propulsion Biofeedback Gait Training (Other)
Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
干预措施: Evaluation of Passive Ankle Stiffness (Other)
Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
干预措施: Gait Biomechanics (Other)
Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
干预措施: Propulsion Biofeedback Gait Training (Other)
Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
干预措施: Clinical Evaluation (Other)
Able-Bodied Participants
Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
干预措施: Clinical Evaluation (Other)
Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
干预措施: Plantar Pressure Biofeedback Gait Training (Other)
Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
干预措施: Gait Biomechanics (Other)
Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
干预措施: Gait Biofeedback (Other)
Able-Bodied Participants
Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
干预措施: Evaluation of Passive Ankle Stiffness (Other)
Able-Bodied Participants
Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
干预措施: Gait Biomechanics (Other)
Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
干预措施: Evaluation of Passive Ankle Stiffness (Other)
Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
干预措施: Gait Biofeedback (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 Day 1)
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 Day 1)
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
Biomechanical modulation of ankle stiffness
时间窗: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Participants will walk for 3 minutes on a treadmill at their self-selected speed to enable stabilization of movement patterns, warmup, and preconditioning of lower extremity muscles prior to dynamometer tasks. Participants will then 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. Electromyography (EMG) activity will be recorded from lower limb muscles 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 at a fixed activation.
次要结局
- Changes induced by biofeedback in biomechanics during gait(Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6))
- Changes induced by biofeedback in propulsion(Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6))
- Changes induced by biofeedback in plantar pressure(Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6))
研究者
Nicole Rendos
Research Scientist
Florida Institute for Human and Machine Cognition