An assistant professor in Northern Arizona University’s Department of Mechanical Engineering has been awarded a $2.1 million grant to launch a five-year clinical trial to test a wearable robotic device that provides neuromuscular training for children with cerebral palsy (CP). Zach Lerner, PhD, will use the funding from the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health & Human Development to test his patented and patent-pending invention of a battery-powered ankle exoskeletal device.
“This is far and away the most significant grant we’ve received to date in terms of duration, budget, and scope,” Lerner said. “The project builds directly on the work we’ve been doing at NAU for the past five years—developing an adaptive ankle exoskeleton device that offers a lightweight, portable, and effective way to improve mobility in children with CP. We completed technological evaluations and the initial clinical feasibility and pilot studies necessary to collect the preliminary data for this randomized controlled trial (RCT), which is the gold standard for clinical trials looking to establish efficacy of a new intervention relative to standard of care.”
Lerner’s team will work with Michael Schwartz, PhD, and his team at Gillette Children’s Specialty Healthcare, St. Paul, Minnesota, to conduct the 12-week gait training intervention. Other aspects of the project will take place in Lerner’s lab and at the Ability & Innovation Lab at the University of Washington.
The exoskeleton technology was developed at NAU and built by Lerner’s spinoff company, Biomotum.
“There is broad clinical consensus that dysfunction of the plantar flexors, or calf muscles, is a primary contributor to slow, inefficient, and crouched walking patterns in individuals with CP,” Lerner said. “Our study will focus on two hypotheses: that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility compared to standard physical therapy and standard gait training, and that adaptive ankle assistance will result in significantly greater capacity and performance compared to walking with ankle foot orthoses and walking wearing just shoes.”
The study will explore participant characteristics, such as age, gender, Gross Motor Function Classification System level, walking speed. and spasticity rating, which are associated with the greatest improvement in outcomes following each intervention. It will provide guidance for future clinical and at-home implementation, establishing fundamental knowledge on the ability for adaptive ankle interventions to treat walking impairment relative to standard of care in CP.
Lerner’s research to date has been funded through a succession of grants totaling more than $4.1 million.
Editor’s note: This story was adapted from materials provided by Northern Arizona University.
