A novel pediatric prosthetic foot for functional multi-axial mobility during active play

Project Summary The goal of this Small Business Innovation Research (SBIR) development project is to establish technical merit, feasibility, and potential to commercialize a mechanical prosthetic foot- ankle with normalized ankle range of motion (RoM) that can be adjusted to meet the needs of children during diverse types of play and activities. The team previously collaborated on a National Institutes of Health (NIH)-funded prosthetic foot development project that resulted in a commercialized product (Meta Arc) and produced many peer-reviewed publications. The Meta Arc is currently the only commercially available prosthetic foot with a polycentric ankle providing 20 degrees of medial-lateral movement for improved stability on uneven terrain. Continuing the successful collaboration, the team will develop a prosthetic foot specifically designed for children. Current prosthetic feet are designed for adults and sometimes are simply miniaturized for children. Because the primary design target population was adults, these designs do not meet the needs of children. Most children's prosthetic feet have similar design features compared to adults: a flexible strut and a covering. However, children engage in activities on uneven terrain where ankle motion is warranted, and in dynamic activities, such as hopscotch, where more rigid ankle mechanics are needed. Simple struts do not sufficiently cover this range of activity. Further, there are additional design challenges with changes in foot size, height, and durability as the child grows; this project will address these challenges. During this Phase I effort, we will complete a pediatric-specific design of a prosthetic foot- ankle system that can be tuned for different types of play. While the team has formulated initial concepts based on conversations with leading pediatric care centers, stakeholder focus groups will help develop and validate the design choices. The stakeholders will include pediatric patients and their parents/guardians, adults with experience as pediatric patients, and pediatric prosthetists. Standardized mechanical testing will confirm that the novel pediatric design meets the expected durability and performance benchmarks before moving into Phase II. Completion of this study is expected to yield an evolved prototype design that is safe for longer-term at- home trials of the system. We seek to restore confidence and functionality by creating a prosthetic foot that spontaneously adapts to the ground surface geometry and uncertain foot placement. The innovative pediatric prosthetic foot will impact children, who need to be able to move freely. Participation in active play is vital to children's physical, social, and psychological development and is an indicator of function, health, and quality of life.