Long-term follow-up of implanted lower extremity neuroprostheses

描述(由申请人提供)： 这项研究的目的是确定植入的下肢神经假体对因瘫痪而行动不便的个人的长期表现。在过去的20年里，在退伍军人管理局赞助的各种研究项目中，植入的功能性电刺激(FES)系统已经安装在20多名志愿者身上，以恢复站立和行走功能。在短期内，植入的下肢运动系统神经假体使使用者能够站立取回和操纵物体，并通过轮椅无法到达的空间，改善一般健康，减少继发性医疗并发症，并获得高度的满意度和使用率。植入组件的长期可靠性和神经假体的临床性能需要评估，以确定这些急性益处是否长期保持。在这项回顾性研究中，我们将a)收集有关瘫痪后站立和行走的植入式神经假体的临床和技术性能的纵向数据，以及b)提供必要的技术支持，以维持最初应用神经假体所取得的功能收益。实验设计将采取一系列多基线案例研究的形式，其中受试者充当自己的植入后历史对照，并对招募稳定性、部件可靠性、功能能力、满意度、使用模式、健康状况和社会参与进行长期后续评估。我们将联系、访谈和带到我们实验室的一批曾接受植入的下肢神经假体的患者进行体检，收集生理和技术数据，并进行长期的功能和临床随访评估。由此产生的数据将最终决定之前报道的神经假体干预的急性结果是否会长期保留，建立系统的长期安全性和稳定性，并阐明这些技术融入用户生活的方式。该项目为退伍军人管理局提供了一个独特的机会，既可以收集关于其开发和传播的技术的慢性、纵向性能和临床实用的原始数据，也可以执行保持神经假体运行所需的例行系统维护，并允许其用户尽可能长时间地保留其恢复的功能。

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.