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-本研究的目的是实现和测试神经机械步态辅助（NMGA）设备 纠正偏瘫退伍军人肌肉无力、不协调或过度紧张的步态 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的中风 在个人、职业和社会角色中发挥作用。 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 用户的意志努力与表面肌肉刺激和电动膝关节辅助协调。 支架安装传感器将用于开发步态事件检测器（GED），这将有助于FSC推进 通过步态或爬楼梯的阶段。此外，基于监督规则的意图检测算法将 使用支架安装的传感器和用户界面输入来在各种功能中进行选择 包括行走、爬楼梯、从坐到站和从站到坐的动作。FSC控制器整定和 意图算法的开发和评估将在三名因中风而有步态缺陷的飞行员身上进行。 开发过程中的结果测量将为新的原型NMGA设计提供规范， 将对三名试点受试者进行评估，以检验NMGA改善步行速度、距离和 步行的能量消耗。这些基线数据和器械将用于设计后续临床试验 测量NMGA对家庭和社区日常生活活动的矫正影响。 方法-在满足入选标准后，飞行员受试者将接受EMG基线步态评估 膝关节屈伸肌、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 阻力他们将配备NMGA结合膝踝足矫形器与机动膝关节， 足底屈肌、背屈肌、股直肌和股前肌的四个表面神经肌肉刺激通道。 支架安装传感器数据将用于步态事件检测器（GED）算法开发和评价。 GED将为FSC提供服务，以基于监督规则的用户意图识别为基础，通过步态阶段进行 通过支架安装传感器和用户输入界面检测算法。FSC将协调前馈 根据需要控制调谐刺激模式和闭环控制膝关节动力辅助，以控制足部 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，一个新的原型NMGA将设计，建造和评估三个试点 受试者测试假设NMGA器械改善了安全性和稳定性，增加了行走速度， 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学显著性所需的重复次数，或 0.2 m/s，行走速度的最小临床重要改善。 临床意义-预期结果是步态稳定性改善，摆动膝关节屈曲改善， 因此，增加了安全性并防止了患有中风偏瘫的能走动的个体的伤害性福尔斯跌倒 在老龄化的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。