For the last couple of years, Bionic Power has been working closely with Dr. Thomas Bulea, a tenure track investigator in the Functional & Applied Biomechanics section of the Rehabilitation Medicine Department at the National Institutes of Health Clinical Center (NIH CC) in Bethesda, Maryland. Over the last few years, Dr. Bulea’s research has focused on the development of pediatric exoskeletons for children with cerebral palsy, spina bifida, and muscular dystrophy. And earlier this spring, Dr. Bulea presented virtually to orthopedic surgeons, physios, and foundations about the work he’s been doing with Bionic Power, and the use of the Agilik in his ongoing clinical trial.
Let’s go back a few years, to 2017, when Dr. Bulea and his colleagues published the results of a study using the first robotic exoskeleton specifically designed to treat crouch gait in children with cerebral palsy. The technology and approach of the NIH pediatric exoskeleton served as the foundation for the Agilik.
As Dr. Bulea said at the time, “Most wearable exoskeletons have been designed for adults with paralysis, with the exoskeleton replacing the lost function of the users. We sought to create a device that could safely and effectively improve the posture of children with crouch gait while they walked. The improvements in their walking, along with their preserved muscle activity, make us optimistic that our approach could train a new walking pattern in these children if deployed over an extended time. This study paves the way for the exoskeleton’s use outside the clinic setting, greatly increasing the amount and intensity of gait training, which we believe is key to successful long-term outcomes in this population.”
“Our approach,” he added back then, “could train a new walking pattern in these children if deployed over an extended time.”
Fast forward to 2019, when Dr. Bulea and his NIH CC team announced the results of their work with the P.Rex—the second generation of the NIH wearable exoskeleton—in children with crouch gait.
By this time, Bionic Power had officially entered into a partnership with the NIH CC. Bionic Power and Dr. Bulea’s federal biomedical research agency signed what’s called a Cooperative Research and Development Agreement (CRADA). CRADAs are written agreements between a private company and a government agency to collaborate on a project.
And as Cerebral Palsy News Today writer Catarina Silva explained, “CRADAs are also one of the principal mechanisms used by federal laboratories to engage in collaborative efforts with private sector partners to disseminate technology.”
Now fast forward again—to June, 2021. The Agilik was P. Rex, only better. More streamlined. Lighter. Smarter.
After starting another clinical trial specifically to evaluate the Agilik, Dr. Bulea and his team remain optimistic about the potential of Bionic Power’s wearable orthotic.
In a paper published in Frontiers in Robotics and AI, Dr. Bulea concluded that, “Gait training via a wearable device in children with cerebral palsy (CP) offers the potential to increase therapy dosage and intensity compared to current approaches.”
“If the goal is to train a new pattern of walking,” he continued, “maintaining or increasing volitional muscle activity during [the Agilik’s] use is critical from a motor learning standpoint.”
Clearly, Dr. Bulea and his colleagues are moving closer to reaching that goal. Two individuals with CP, ages 8 and 25, and one 8-year-old with spina bifida (the first SB participant in the trial to date) have completed the study. After 10 visits to Dr. Bulea’s Bethesda lab, “we measured improvements in crouch when walking with and without the Agilik,” he said via Zoom. When discussing the Agilik’s ability to offer on-demand resistance during walking, he said, “the Agilik became an exercise device in this mode. It challenged the kids in our study to use their own muscles.”
The response among the virtual attendees was enthusiastic—and one physician requested the Agilik be brought to her practice, which focuses on CP and SB clients, for a demonstration.
It’s Dr. Bulea’s goal—and Bionic Power’s—to develop wearable orthotic devices that will significantly improve the lives of individuals dealing with movement disorders. While it does provide assistance, the Agilik still requires children with CP, SB, and other disorders to use “volitional control,” pointed out Dr. Bulea. The Agilik has the potential to help its users walk more easily, improve their postures significantly, help them gain strength, balance, confidence, and best of all, the effects should translate to outside the clinic.
“The more trial participants used the Agilik,” said Dr. Bulea, “the more they improved. These wearable devices have the potential to advance locomotor training beyond the clinic environment, which could greatly increase the amount and intensity of training.”