Stimulation combined with externally powered motorized orthoses for stroke

刺激结合外部动力电动矫形器治疗中风

• 批准号: 10329995
• 负责人: RONALD J TRIOLO
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329995
• 关键词: Abnormal coordination; Acceleration; Activities of Daily Living; Address; Affect; Aging; Algorithms; Ankle; Back; Clinical; Clinical Trials; Communities; Consumption; Data; Detection; Development; Device Designs; Devices; Disabled Persons; Evaluation; Event; Exercise; Extensor; Family; Family member; Feedback; Flexor; Future; Gait; Goals; Health Benefit; Hemiplegia; Hip region structure; Home; Hybrids; Individual; Intervention; Intuition; Isotonic Exercise; Joints; Knee; Knee joint; Laboratories; Lead; Limb structure; Manuals; Measures; Metabolic; Methodology; Motor; Movement; Muscle; Muscle Weakness; Neuromechanics; Orthotic Devices; Outcome; Outcome Measure; Outcome Study; Output; Pattern; Phase; Population; Preparation; Professional Role; Quality of life; Religion and Spirituality; Research; Resistance; Role; Safety; Self-Help Devices; Societies; Stroke; Surface; System; Systems Development; Testing; Toes; Traumatic Brain Injury; Veterans; Volition; Walking; Work; algorithm development; base; clinically significant; design; design and construction; detector; dexterity; exoskeleton; experience; fall injury; fall risk; feasibility testing; follow-up; foot; functional outcomes; hemiparesis; improved; inclusion criteria; instrument; meetings; military veteran; neural stimulation; neuromuscular stimulation; novel; pilot test; prevent; prototype; rectus femoris; sensor; social; stroke survivor; synergism; walking speed

Objective - The objective of this study is to implement and test a neuro-mechanical gait assist (NMGA) device to correct gait characterized by muscle weakness, incoordination or excessive tone in veterans with hemiplegia from stroke that adversely affect their ability to walk, exercise, perform activities of daily living, and participate fully in personal, professional and social roles. Research Plan – Prototype NMGA device will be used to develop a finite state controller (FSC) to coordinate user’s volitional effort coordinated with surface muscle stimulation and motorized knee assist as needed. Brace mounted sensors will be used to develop gait event detector (GED) which will serve the FSC to advance through the phases of gait or stair climbing. In addition, a supervisory rule-base intent detection algorithm will be developed using brace mounted sensors and user interface input to select among various functions including walking, stairs climbing, sit-to-stand and stand-to-sit maneuvers. The FSC controller tuning and intent algorithm development and evaluation will be on three pilot subjects with gait deficits from stroke. Outcome measures during development will provide specifications for a new prototype NMGA design which will be evaluated on three pilot subjects to test hypothesis that NMGA improves walking speed, distance and energy consumption of walking. These baseline data and device will be used to design a follow-up clinical trial to measure orthotic impact of NMGA on mobility in activities of daily living at home and community. Methodology – After meeting inclusion criteria, pilot subjects will undergo baseline gait evaluation with EMG activities of knee flexors and extensors, ankle plantar and dorsiflexors and isokinetic knee strength and passive resistance. They will be fitted with NMGA combining knee-ankle-foot-orthosis with motorized knee joint and four channels of surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. Brace mounted sensor data will be used for gait event detector (GED) algorithm development and evaluation. GED will serve FSC to proceed through phases of gait based on supervisory rule-based user intent recognition algorithm detected by brace mounted sensors and user input interface. FSC will coordinate feed-forward control of tuned stimulation patterns and closed-loop controlled knee power assist as needed to control foot clearance during swing and stability of the knee during stance. Based on data attained during controller development and evaluation, a new prototype NMGA will be design, constructed and evaluated on three pilot subjects to test hypothesis that NMGA device improves safety and stability, increases walking speed and distance and minimizes user effort. For all experimental conditions, a statistical power of 90% was used to determine the number of repetitions required in the single subject design to detect statistically significant or 0.2m/s minimal clinically important improvement in walking speed. Clinical Significance - The anticipated outcome is improved gait stability with improved swing knee flexion, thus, increasing the safety and preventing injurious falls of ambulatory individuals with hemiplegia due to stroke found in large and ever-increasing numbers in the aging veteran population. Correcting gait should lead to improved quality of life and participation.

目的 - 本研究的目的是实施和测试神经机械步态辅助 (NMGA) 设备 纠正偏瘫退伍军人以肌肉无力、不协调或过度紧张为特征的步态 中风对他们的行走、锻炼、日常生活活动和参与能力产生不利影响 充分发挥个人、专业和社会角色。 研究计划——原型 NMGA 设备将用于开发有限状态控制器 (FSC) 来协调 根据需要，用户的意志努力与表面肌肉刺激和机动膝盖辅助相协调。 安装支架的传感器将用于开发步态事件检测器 (GED)，该检测器将服务于 FSC 推进 通过步态或爬楼梯的阶段。此外，监督规则库意图检测算法将 使用支架安装的传感器和用户界面输入进行开发，以在各种功能之间进行选择 包括步行、爬楼梯、从坐到站和从站到坐的动作。 FSC 控制器调整和 意图算法的开发和评估将针对三名因中风而出现步态缺陷的试点受试者。 开发期间的成果衡量将为新的 NMGA 原型设计提供规范，该设计 将在三个试点受试者上进行评估，以检验 NMGA 提高步行速度、距离和步行速度的假设 步行的能量消耗。这些基线数据和设备将用于设计后续临床试验 衡量 NMGA 对家庭和社区日常生活活动活动能力的影响。 方法 - 满足纳入标准后，试点受试者将接受肌电图基线步态评估 膝关节屈肌和伸肌、踝关节跖屈肌和背屈肌的活动以及等速膝关节力量和被动 反抗。他们将配备结合膝踝足矫形器和机动膝关节的 NMGA 跖屈肌、背屈肌、股直肌和股直肌的表面神经肌肉刺激的四个通道。 安装支架的传感器数据将用于步态事件检测器 (GED) 算法的开发和评估。 GED 将服务 FSC，以基于基于监管规则的用户意图识别来完成步态阶段 由支架安装的传感器和用户输入界面检测的算法。 FSC 将协调前馈 根据控制足部的需要控制调谐刺激模式和闭环控制膝关节动力辅助 摆动时的间隙和站立时膝盖的稳定性。基于控制器期间获得的数据 开发和评估，新的 NMGA 原型机将在三个试点上进行设计、建造和评估 测试 NMGA 装置提高安全性和稳定性、提高行走速度和 距离并最大限度地减少用户的工作量。对于所有实验条件，使用 90% 的统计功效 确定单个受试者设计中检测统计显着性或显着性所需的重复次数 0.2m/s 步行速度的最小临床重要改善。 临床意义 - 预期结果是通过改善摆动膝关节屈曲来改善步态稳定性， 因此，提高中风偏瘫患者的安全性并防止其跌倒受伤 在老龄化退伍军人中发现了大量且不断增加的数量。纠正步态应该会导致 提高生活质量和参与度。