Long-term follow-up of implanted lower extremity neuroprostheses

植入下肢神经假体的长期随访

• 批准号: 8196156
• 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: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8196156
• 关键词: Activities of Daily Living; Acute; Address; Am 80; Area; Behavior; Body Weight; Case Study; Chronic; Clinical; Collection; Data; Devices; Electric Stimulation; Electrodes; Exercise; Experimental Designs; Failure; Functional disorder; Future; Health; Health Status; Impairment; Implant; Implanted Electrodes; Individual; Institution; Intervention; Interview; Intramuscular; Laboratories; Leg; Leisure Activities; Life; Life Style; Longevity; Longitudinal Studies; Lower Extremity; Maintenance; Measurement; Measures; Mechanics; Mediation; Motor; Movement; Nerve; Neuraxis; Operative Surgical Procedures; Outcome; Paralysed; Participant; Pattern; Performance; Physical Examination; Physiological; Probability; Property; Questionnaires; Reaction; Rehabilitation therapy; Relative (related person); Reporting; Research Project Grants; Research Subjects; Retrospective Studies; Safety; Sampling; Series; Speed; Spinal cord injury; Stimulus; Structure; Surveys; System; Technology; Time; Tissues; Walking; Wheelchairs; Work; base; cohort; design; follow-up; functional gain; functional outcomes; functional restoration; implantation; impression; improved; medical complication; neuroprosthesis; research study; response; satisfaction; social; volunteer; Activities of Daily Living; Acute; Address; Am 80; Area; Behavior; Body Weight; Case Study; Chronic; Clinical; Collection; Data; Devices; Electric Stimulation; Electrodes; Exercise; Experimental Designs; Failure; Functional disorder; Future; Health; Health Status; Impairment; Implant; Implanted Electrodes; Individual; Institution; Intervention; Interview; Intramuscular; Laboratories; Leg; Leisure Activities; Life; Life Style; Longevity; Longitudinal Studies; Lower Extremity; Maintenance; Measurement; Measures; Mechanics; Mediation; Motor; Movement; Nerve; Neuraxis; Operative Surgical Procedures; Outcome; Paralysed; Participant; Pattern; Performance; Physical Examination; Physiological; Probability; Property; Questionnaires; Reaction; Rehabilitation therapy; Relative (related person); Reporting; Research Project Grants; Research Subjects; Retrospective Studies; Safety; Sampling; Series; Speed; Spinal cord injury; Stimulus; Structure; Surveys; System; Technology; Time; Tissues; Walking; Wheelchairs; Work; base; cohort; design; follow-up; functional gain; functional outcomes; functional restoration; implantation; impression; improved; medical complication; neuroprosthesis; research study; response; satisfaction; social; volunteer

DESCRIPTION (provided by applicant): The purpose of this study is to determine the long-term performance of implanted lower extremity neuroprostheses for individuals with mobility impairments due to paralysis. Implanted functional electrical stimulation (FES) systems to restore standing and walking function have been installed in more than two dozen volunteers in various VA-sponsored research projects over the past two decades. In the short term, implanted lower extremity motor system neurorpostheses enable users to stand to retrieve and manipulate objects and negotiate spaces inaccessible to the wheelchair, improve general health, reduce secondary medical complications, and elicit high degrees of satisfaction and usage. The long-term reliability of the implanted components and clinical performance of the neuroprostheses need to be evaluated to determine whether these acute benefits are maintained chronically. In this retrospective study we will a) collect longitudinal data on the clinical and technical performances of implanted neuroprostheses for standing and walking after paralysis, and b) provide the technical support necessary to maintain the functional gains achieved with the initial application of the neuroprosthesis. The experimental design will take the form of a series of multiple-baseline case studies in which subjects act as their own historical controls for post-implant and long-term follow-up assessments of recruitment stability, component reliability, functional capacity, satisfaction, patterns of usage, health status and societal participation. A cohort of former recipients of implanted lower extremity neuroprostheses will be contacted, interviewed and brought to our laboratory for physical examination, collection of physiological and technical data, and long-term functional and clinical follow-up assessment. The resulting data will definitively determine whether the acute outcomes of neuroprosthetic interventions previously reported are retained long-term, establish the chronic safety and stability of the systems, and elucidate the manner in which the technologies are incorporated into the lives of their users. This project provides the VA with a unique opportunity to both collect original data regarding the chronic, longitudinal performance and clinical utility of the technologies that it developed and disseminated, as well as to perform the routine system maintenance required to keep the neuroprostheses operational and allow their users to retain their restored function for as long as possible.

描述（由申请人提供）： 这项研究的目的是确定由于麻痹而导致迁移率障碍的个体植入下肢神经植物的长期性能。在过去的二十年中，在各种VA赞助的研究项目中，已将植入的功能电刺激（FES）系统安装在二十多名志愿者中。在短期内，植入的下肢运动系统神经斑点使用户能够忍受检索和操纵物体，并协商轮椅无法访问的空间，改善一般健康，减少二次医疗并发症，并引起高度的满意度和用法。需要评估植入成分的长期可靠性和神经植物的临床性能，以确定这些急性益处是否长期维持。 在这项回顾性研究中，我们将a）收集有关植入神经植物的临床和技术性能的纵向数据，用于瘫痪后站立和行走，b）提供了维持神经假体最初应用实现功能增长所必需的技术支持。实验设计将采用一系列多基线案例研究的形式，其中受试者对招聘稳定性，组件可靠性，功能能力，满意度，使用方式，健康状况和社会参与的募集后和长期随访评估进行了自身的历史控制。将与植入下肢神经植物的前前接受者组成的队列进行，采访并将其带到我们的实验室进行体格检查，收集生理和技术数据，以及长期功能和临床随访评估。最终的数据将确定确定先前报告的神经假体干预措施的急性结果是否长期保留，确定系统的慢性安全性和稳定性，并阐明将技术纳入其用户生活的方式。 该项目为VA提供了一个独特的机会，可以收集有关其开发和传播技术的慢性，纵向性能和临床实用性的原始数据，以及执行所需的常规系统维护，以保持神经plothesses的运行，并使他们的用户可以尽可能长时间地保留其恢复功能。