New upper-extremity assistive appliances coming into the orthotics and prosthetics (O&P) market are increasingly technologically sophisticated and expensive, which has given rise to a growing population of amputees who cannot obtain them or make use of them for various reasons and thereby enjoy no benefit. Current estimates put the number of upper-extremity amputees worldwide at nearly 25,000,000 persons, with approximately 80% of these living in rural areas and surviving through agriculture and animal husbandry. It is advantageous to help these amputees because experience has shown that with functional restoration comes renewed self-sufficiency and independence, and a majority of amputees fit with functional prostheses resume productive occupations, benefiting themselves, their families, and society at large. For this reason, some humanitarian agencies focus on providing assistive appliances, and while lower-extremity prosthetic options exist, they have been hampered in their efforts to assist upper-extremity amputees owing to a lack of affordable hardware. The Fundamental Objective of this three-phase SBIR program is to create a complete upper-extremity prosthesis that can be manufactured and distributed on a large scale to enable and delight disadvantaged amputees for whom few or no other viable rehabilitative options exist. In Phase I of this SBIR project, ADA successfully demonstrated the technical and economic feasibility of a new low-cost upper- extremity prosthesis intentionally designed for distribution in the United States and abroad to overcome treatment disparities affecting under-served populations. As recommended by expert prosthetists active in humanitarian relief efforts, ADA's prosthetic system conveys specific benefits to amputees: 1) it is comfortable and restores useful grasping function;2) it alleviates emotional and psychological shock caused by amputation and fosters a positive self-image;and 3) it restores a more normal appearance that bolsters social acceptance, particularly in cultures having strong stigmas against disfigurement and disability. Phase II incorporates two stages of field validations involving human subjects. These evaluations will be IRB- approved and will enable ADA's well-qualified research team to fully validate the system's performance, amputees'functional proficiency using it, and its acceptability in a cultural context. A kit comprising the prosthesis and additional materials will be developed to facilitate global distribution while helping amputees become proficient and able to use the systems to maximum advantage in their lives. Finally, manufacturing infrastructure will be set up to supply Phase III market demand;distribution channels already exist and have expressed their eagerness to begin supplying ADA's system to their clients.
