Triolo R, Nathan R, Handa Y, Keith M, Betz R R, Carroll S, Kantor C
Department of Orthopaedics, Case Western Reserve University, Cleveland, OH, USA.
J Rehabil Res Dev. 1996 Apr;33(2):111-22.
The technology for functional neuromuscular stimulation (FNS) as a means of providing upper limb function to people with tetraplegia has been under development by three clinical research groups for almost two decades. This paper presents the current status of the clinical trials of three FNS systems: a noninvasive system built into a cosmetic forearm splint, a 30-channel percutaneous system, and an 8-channel implantable system. The complexity of FNS systems and the unique characteristics of the individuals to whom they are applied combine to create many clinical and technical challenges that must be addressed before the devices can be deployed. The emerging challenges to widespread clinical introduction of FNS systems for hand and arm function are identified and analyzed. In addition to the demands of designed and conducting the clinical trials to satisfy regulatory requirements, the lack of knowledge, skepticism, and the complacency on the part of potential FNS recipients, as well as of rehabilitation professionals, must be overcome through education and careful consideration of economic and societal factors in the design of clinical systems.
作为为四肢瘫痪患者提供上肢功能的一种手段，功能性神经肌肉刺激（FNS）技术已经由三个临床研究小组开发了近二十年。本文介绍了三种FNS系统的临床试验现状：一种内置在美容前臂夹板中的无创系统、一种30通道经皮系统和一种8通道植入式系统。FNS系统的复杂性以及其应用对象的独特特征共同带来了许多临床和技术挑战，在这些设备能够部署之前必须加以解决。本文识别并分析了FNS系统广泛应用于手部和手臂功能所面临的新挑战。除了设计和开展满足监管要求的临床试验的需求之外，还必须通过教育以及在临床系统设计中仔细考虑经济和社会因素，来克服潜在FNS接受者以及康复专业人员方面存在的知识欠缺、怀疑态度和自满情绪。
