The development of a prosthetic monitoring system for outcomes-based research and clinical applications is proposed. This device will provide researchers and clinicians with the first commercially available method to objectively quantify the selection and alignment of prosthetic components, thereby promoting improved health and well being of the amputee. The Intelligent Prosthetic Endoskeletal Component System (iPecs"") is a measurement tool intended to support researchers and clinicians in their optimization of patient care specifically to provide objective information on the effects of prosthetic component selection and alignment. Clinical use of the iPecsTM device will allow clinicians to directly measure what they are seeing and what prosthesis users are feeling. The software developed in conjunction with the iPecsTM device will assist the prosthetist in proper selection and alignment of prosthetic components, which should improve patient outcomes. This device fulfills the desired functional requirements as outlined by Dr. Doran Edwards, the Medical Director of Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) and will be universally adaptable with standard mounting components used in the finished prosthetic limb. It will allow the desired data to be collected without interfering with the normal function of the prosthesis. This freedom from current constraints will provide a much more accurate picture of how the prosthesis user functions in normal daily activities. This level of function is not currently available, but is critical in understanding the interactions between the prosthesis and the user. The numerous and repeated requests by the prosthetics industry, researchers and governmental agencies for tools to develop specifications and standards suggest that commercialization of this product be directed toward multiple markets: institutions of higher education and research laboratories, prosthetic clinics, and patient use. The method to be used in the Phase I development process will be to build, calibrate and validate the proposed iPecsTM device. College Park Industries (CPI) will build and calibrate the prototype. Validation testing will be conducted by researchers at Northwestern University. A future Phase II proposal will include human subjects testing and a commercialization plan for the iPecsTM. PUBLIC HEALTH RELEVANCE. The Intelligent Prosthetic Endoskeletal Component System (iPecs"") is a measurement tool intended to support researchers and clinicians in their optimization of patient care. The iPecs"" device is designed to be an affordable, practical tool for use in clinical applications to support daily fitting, rehabilitation, and monitoring of lower limb prosthesis users. Improved fitting and rehabilitation of prosthesis users should result in greater patient mobility, leading to multiple long term health benefits.
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