The
trial will test functionality, gauge the effect on the children’s
quality of life, and determine how they use the arm for specialized
tasks.
Photograph courtesy of OHSU/Kristyna Wentz-Graff.
A
partnership between Oregon Health & Science University (OHSU) and
Limbitless Solutions, a nonprofit organization based at the University
of Central Florida (UCF), has led to the launch of the first U.S.
clinical trial of 3D-printed myoelectric upper-limb prostheses for
children. Albert Chi, MD, associate professor of surgery in the OHSU
School of Medicine, will be the lead clinical investigator in
collaboration with Albert Manero, PhD, the CEO and a cofounder of
Limbitless Solutions, which developed the prosthesis. Chi directs the
targeted muscle reinnervation program at OHSU.
The prostheses
operate using a pair of leads placed on the skin that activate as
children flex their muscles. Each device can be produced in the UCF lab
at a hardware cost of less than $1,000. The latest version of the arm
includes multiple motors and smart phone technology to improve a child’s
ability to grip objects and perform various gestures.
The
clinical trial is recruiting 20 children, 6-17 years old, who will be
fitted with Limbitless prostheses. Occupational therapy will be provided
over the course of one year in Orlando, Florida, and Portland, Oregon.
The trial will test the functionality of the arms, gauge the effect on
the children’s quality of life, and determine how they use the arm for
specialized tasks. The results will help determine whether the U.S. Food
and Drug Administration would approve the arm for market clearance. The
researchers hope that this is the first of several U.S. trials.
The
trial is open to children nationwide, but participants are primarily
being recruited from the Southeastern United States and the Pacific
Northwest, as proximity to the two trial sites is key to completing the
year-long process.
Editor’s note: This story was adapted from materials provided by OHSU.
