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.

Grant Number: 1R43HD117457-01
NIH Institute/Center: NIH
Principal Investigator: Katheryn Allyn