Automatic Control of Standing Balance and Gait with Implanted Neuroprostheses

利用植入神经假体自动控制站立平衡和步态

• 批准号: 10231225
• 负责人: Musa L Audu
• 金额: $ 51.07万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-21 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10231225
• 关键词: Activities of Daily Living; Algorithms; Anatomy; Ankle; Biological; Clinical; Clinical Research; Clinical Trials; Communities; Computer Simulation; Computer software; Consent Forms; Development; Devices; Effectiveness; Elements; Ensure; Equilibrium; Extensor; Feasibility Studies; Gait; Goals; Hip region structure; Home; Implant; Individual; Institutional Review Boards; Intervention; Investigation; Knee; Knowledge; Laboratories; Lateral; Limb structure; Location; Lower Extremity; Methods; Motor; Muscle; Operative Surgical Procedures; Outcome; Paralysed; Paraplegia; Pattern; Performance; Periodicity; Peripheral Nerve Stimulation; Persons; Phase; Positioning Attribute; Posture; Preparation; Protocols documentation; Quadriplegia; Research; Resources; Robot; Safety; Signal Transduction; Specific qualifier value; Spinal cord injury; System; Techniques; Testing; Time; Translating; Translations; United States Food and Drug Administration; Upper Extremity; Volition; Walkers; Walking; Work; arm; base; biomechanical model; clinical implementation; foot; hand grasp; in silico; kinematics; models and simulation; neural prosthesis; neural stimulation; neuroprosthesis; operation; prevent; response; sensor; simulation; usability; volunteer

The overall goal of the proposed research is to develop a new control system to maintain standing balance at various task-dependent, user-specified postures, and enable dynamically stable reciprocal stepping in persons paralyzed by spinal cord injuries (SCI) with an implanted motor system neuroprosthesis (NP) and prepare for ensuing home-going trials and clinical dissemination. A system that automatically modulate neural stimulation to maintain standing balance and generate successive reactive steps to achieve effective reciprocal gait will be translated to the Networked Neural Prosthesis System (NNPS). Each module of the NNPS contains internal sensors that would eliminate the need for external devices and cabling. The project will determine the feasibility of a safe and functional LE motor system NP that can be realized with a fully implantable system suitable for home and community use. Aim 1 will determine effective and efficient methods to estimate whole body center of mass (CoM) kinematics and evaluate suitability for real-time control with the NNPS. This will entail estimating CoM from external sensors attached to able-bodied volunteers and current recipients of standing and stepping NPs at the anticipated surgical location of modules of the NNPS. We will implement our existing biologically-inspired standing balance and stepping controllers with NNPS simulated signals in volunteers with SCI and evaluate their performance in response to internally generated and externally applied disturbances. Aim 2 will extend the control system to automatically generate successive reactive steps, and enhance inter-limb loading and dynamic balance during stance phases of gait. A system that enables forward progression of the CoM to maintain balance in the medio-lateral direction, optimizes forward propulsion, and ensures proper swing limb foot placement during successive reactive steps will be developed in simulation, and experimentally validated with able-bodied volunteers and recipients of implanted NPs. Our existing control systems for bipedal stance and reactive stepping will be adapted to maintain balance and achieve smooth translation of CoM during walking and recent development in the field of walking robots will be applied. We expect that walking with the extended biologically-inspired control system will be smoother, more efficient and more resilient to potential destabilizing influences than conventional pre-programmed stimulation. Aim 3 will create the resources required to translate the standing and walking controllers to the new NNPS platform in preparation for clinical implementation and ensuing home-going trials. Work will develop, document and verify operation of lower extremity-specific software and clinical/user interfaces to the NNPS. We will prepare and submit an Investigation Device Exemption to the USFDA for a new feasibility study of LE applications of the NNPS in preparation for ensuing clinical trials of safety and effectiveness.

拟议研究的总体目标是开发一种新的控制系统，以 在各种任务相关、用户指定的姿势下保持站立平衡，以及 使脊髓瘫痪患者能够动态稳定地往返行走 植入运动系统神经假体(NP)的损伤(SCI)和准备 随后的回家试验和临床传播。一种自动的系统 调制神经刺激以保持站立平衡并产生连续的 实现有效互惠步态的反应性步骤将转化为网络 神经假体系统(NNPS)。NNPS的每个模块都包含内部传感器 这将消除对外部设备和布线的需求。该项目将 确定安全有效的LE发动机系统NP的可行性，该系统可以 实现了适合家庭和社区使用的完全植入式系统。 目标1将确定有效和高效的方法来估计人体的全身中心 MASS(COM)运动学和评估是否适合使用NNPS进行实时控制。这 将需要从连接到健全志愿者的外部传感器和 目前在预期的手术位置接受站立和行走NPs的人 核动力源的模块。我们将实施我们现有的生物启发的立场 脊髓损伤志愿者NNPS模拟信号的平衡和步进控制器 并根据内部产生的和外部的响应来评估其绩效 外加干扰。AIM 2将扩展控制系统以自动生成 连续的反应步骤，并增强肢体之间的负荷和动态平衡 步态的站立阶段。一种能够将COM向前推进到 保持中侧向平衡，优化向前推进，以及 确保在连续的反应步骤中适当地摆动肢体脚部 在模拟中开发，并在健全的志愿者和 植入NPs的接受者。我们现有的两足动物站姿和控制系统 将采用反应式步进来保持平衡并实现平滑的平移 COM在行走过程中，以及行走机器人领域的最新发展将是 已申请。我们希望用扩展的生物灵感控制系统行走 将更顺畅、更高效、更具弹性地应对潜在的不稳定影响 而不是常规的预编程刺激。目标3将创建资源 需要将站立和行走控制器转换到新的NNPS平台 为临床实施和随后的回家试验做准备。工作将会 开发、记录和验证特定于腿部的软件和操作 NNPS的临床/用户界面。我们将准备并提交一份调查装置 豁免美国食品和药物管理局在#年进行核电厂LE应用的新可行性研究 为随后的安全性和有效性临床试验做准备。