Abstract

On May 18, 1992 a symposium at Case Western Reserve University in Cleveland, Ohio, USA had the goal of defining the tasks needed to reach clinical utility of investigational neural prosthetic ambulation devices. The characteristics and stage of development of four systems were detailed: the Louiiana State University reciprocating gait orthosis (LSU-RGO) with muscle stimulation; the modular hybrid functional neuromuscular stimulation (FNS) orthosis; the Cleveland VA-Case Western Reserve University (VA-CWRU) implant system; and the Parastep system. Multicenter clinical trials are underway for the Parastep system and are planned to start within the next 2 years for the LSU-RGO with muscle stimulation, the VA-CWRU 8-channel system, and the floor reaction orthosis component of the modular hybrid FNS system. Current investigational systems provide little advantage over the standing wheelchair in some occupations but they do expand social, recreational, and exercise capabilities. Disabled people and some leading rehabilitation physicians are willing to test basic ambulation devices but the regulatory approvals must first be obtained for multicenter clinical trials. Corporate partners are central to the development of devices, their clinical testing, and their subsequent marketing. A key requirement for developing and disseminating motor prostheses is the education of clinicians so that they will participate in trials and be prepared to prescribe the prostheses when they reach the market.

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