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: 10543078
• 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 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10543078
• 关键词: Abnormal coordination; Acceleration; Activities of Daily Living; Address; Affect; Aging; Algorithms; Ankle; Back; Clinical; Clinical Trials; Communities; Data; Detection; Development; Device Designs; Devices; Disabled Persons; Energy consumption; 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; 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; Recreation; Religion; Research; Resistance; Role; Safety; Self-Help Devices; Societies; Specific qualifier value; Stroke; Surface; System; Systems Development; Testing; Toes; Traumatic Brain Injury; Veterans; 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; gait correction; 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聚集辅助设备（NMGA）设备 纠正以肌肉无力，不协调或超过偏瘫的退伍军人的音调为特征的步态 从中风，不利地影响他们走路，锻炼，执行日常生活的活动和参与的能力 充分扮演个人，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）以协调 用户的自愿努力与表面肌肉模拟和电动膝盖辅助协调。 支架安装的传感器将用于开发步态事件探测器（GED），该检测器将为FSC提供前进 穿过攀登或雄鹿攀爬的阶段。此外，监督规则基础意图检测算法将 可以使用支架安装的传感器和用户界面输入开发以在各种功能中进行选择 包括散步，爬楼梯，坐下来和站立的演习。 FSC控制器调整和 意图算法的开发和评估将在三个具有步态定义的试点受试者上。 开发过程中的结果指标将为新的原型NMGA设计提供规格 将对三个试点受试者进行评估，以测试NMGA提高步行速度，距离和 步行的能耗。这些基线数据和设备将用于设计后续临床试验 衡量NMGA对在家和社区日常生活活动中的矫正影响。 方法论 - 符合纳入标准后，试点受试者将接受基线收集评估 膝盖屈肌和伸展的活动，脚踝和背屈者以及等速膝强度和被动 反抗。他们将配备NMGA，将膝盖 - 骨骼正他骨与电动膝关节和 底部和背膜的四个表面神经肌肉刺激，股骨和直肌。 支架安装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将在基于基于监督规则的用户意图识别的基于步态的阶段进行FSC进行。 通过支撑传感器和用户输入接口检测到的算法。 FSC将协调前馈 根据需要控制调谐刺激模式和闭环控制的膝关节功率辅助 挥杆和膝盖稳定性期间的间隙。基于在控制器期间获得的数据 开发和评估，将在三个飞行员上设计，构建和评估一个新的NMGA原型 受试者测试假设，即NMGA设备可提高安全性和稳定性，提高步行速度和 距离并最小化用户工作。对于所有实验条件，使用90％的统计功率 确定单个主题设计中所需的重复数量，以检测具有统计学意义或 0.2m/s的步行速度最小临床上重要的改善。 临床意义 - 预期的结果将改善轴线稳定性，并改善了膝盖屈曲， 因此，提高安全性并防止偏瘫患者中风引起的伤害性跌倒 在老年退伍军人人口中发现的数量众多。纠正步态应导致 改善生活质量和参与。