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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

基本信息

批准号：
10462584
负责人：
Musa L Audu
金额：
$ 48.03万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
起止时间：
2000-09-21 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10462584
关键词：
Activities of Daily Living Algorithms Anatomy Ankle 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

项目摘要

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.

本研究的总体目标是开发一种新的控制系统，在各种任务相关、用户指定的姿势下保持站立平衡，使脊髓麻痹的人能够动态稳定地相互迈步用植入的运动系统神经假体（NP）治疗脊髓损伤（SCI），随后的国内试验和临床传播。一个系统，自动调节神经刺激以维持站立平衡并产生连续的反应步骤，以实现有效的互惠步态将被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电缆的需要。该项目将确定安全和功能性LE电机系统NP的可行性，实现了一个完全植入式系统，适合家庭和社区使用。目的1将确定有效和高效的方法来估计全身中心质量（CoM）运动学和评估与NNPS实时控制的适用性。这将需要从连接到身体健全的志愿者的外部传感器估计CoM，目前接受站立和步进NP的患者在预期的手术位置， NNPS的模块。我们将实施我们现有的生物启发的立场， SCI志愿者的平衡和步进控制器与NNPS模拟信号并评估他们的表现，以应对内部和外部产生的施加干扰。Aim 2将扩展控制系统，连续的反应步骤，并增强肢体间的负荷和动态平衡，步态的站立阶段。一种使CoM能够向前发展的系统，保持中-外侧方向的平衡，优化向前推进力，确保在连续的反应步骤中正确的摆动肢体脚放置，在模拟中开发，并通过健全的志愿者进行实验验证，植入NP的受体。我们现有的双足站立控制系统，反应性步进将被调整以保持平衡并实现平滑的平移， CoM在步行和步行机器人领域的最新发展将是应用。我们希望通过扩展的生物控制系统行走将更平稳、更高效，更能抵御潜在的不稳定影响比传统的预编程刺激更有效目标3将创造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国内试验做准备。工作将开发、记录和验证下端专用软件的运行， NNPS的临床/用户界面。我们将准备并提交一份调查器械豁免USFDA对NNPS LE应用进行新的可行性研究，为随后的安全性和有效性临床试验做准备。