Virginia Tech, Ohio State University and Nationwide Children’s Hospital joined together to create the $5 million, NIH-funded center
Credit: Clayton Metz/Virginia Tech
Research partners across three institutions are opening the nation’s first and only resource center dedicated to promoting clinical trials research in the rapidly expanding field of pediatric rehabilitation.
Sharon Landesman Ramey, research professor and distinguished research scholar at the Fralin Biomedical Research Institute, will direct the new center — a partnership between Virginia Tech, Ohio State University and Nationwide Children’s Hospital — to help clinical scientists in pediatric rehabilitation research by funding pilot studies and offering courses and mentored experiences.
The award builds on the groundbreaking research and discoveries at the institute’s Neuromotor Research Clinic, which Stephanie DeLuca, an associate professor at the institute, directs with Landesman Ramey. Virginia Tech will expand its role as an infrastructure base to encourage other researchers to broaden their focus.
The National Pediatric Rehabilitation Resource Center is known informally among its scientists as C-PROGRESS, an acronym for Center for Pediatric Rehabilitation: Growing Research, Educating, and Sharing Science. The nickname reflects the team’s primary objective of “seeing progress” in the relatively new and emerging field of pediatric rehabilitation science, and the group will broadly support pediatric rehabilitation research, providing up to $150,000 a year for pilot studies.
C-PROGRESS is a partnership among six researchers at three institutions, including Landesman Ramey, DeLuca, and also Virginia Tech’s Craig Ramey, a research professor and distinguished research scholar at the Fralin Biomedical Research Institute. From Ohio State University, Jill Heathcock, an associate professor and director of the Infant Lab, and Amy Darragh, director of the Occupational Therapy Division in the College of Medicine, complete the partnership with Warren Lo, attending pediatric neurologist at Nationwide Children’s and Clinical Professor of Pediatrics and Neurology at the OSU College of Medicine.
The scientists have worked together for nearly a decade, innovating treatments and measures for children’s rehabilitation progress and leading clinical trials. Currently, the team is also leading a Phase III clinical trial funded as part of StrokeNet, testing two doses of an intervention to treat infants with Perinatal Stroke that occurs within the first month of life.
The new center is a response to growing demand for effective rehabilitation methods. Hundreds of thousands of children in the U.S. are impacted annually by prenatal and infant stroke, cerebral palsy, traumatic and acquired brain injury, and neuromuscular disorders – conditions once deemed in many cases to be “static,” “degenerative,” and “incurable.” That view is no longer held. Investigators, including those at Virginia Tech, Ohio State, and Nationwide Children’s, are developing, implementing and evaluating new approaches to change the trajectory of these disorders and childrens’ lives.
“We simply have not had a full-court attack scientifically to find out how far these children can progress with the right level of investments at the right time,” Landesman Ramey said.
The field of pediatric rehabilitation has grown tremendously in the past 15 years, but the C-PROGRESS team predicts the next five years can become a period of swift, strong consolidation of research goals, recruitment of new investigators, and the development of new protocols to expand interdisciplinary research and conduct much-needed, rigorous Phase II and Phase III clinical trials.
It will be one of a network six centers under the umbrella of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health, with direct oversight from the National Center for Medical Rehabilitation Research.
Co-funding for the $5 million is provided by the National Institute of Neurological Disorders and Stroke and the National Institute of Biomedical Imaging and Bioengineering.
The C-PROGRESS team believes pediatric rehabilitation confronts unique issues, challenges, and opportunities that distinguish it from the larger field of adult rehabilitation.
Very young children’s brains and behavior possess substantial capacity for plasticity with the ability to develop in dynamic ways that benefit the child’s entire nervous system and behavioral range.
The team at the Neuromotor Research Clinic often sees “spillover effects” from motor treatments – changes in children’s speech and language, social understanding and interactions, curiosity, emotional self-regulation, and advances in learning and cognition.
“The right types and amounts of rehabilitation can be transformative for a young child and for the family as well,” Landesman Ramey said. “We have vastly underestimated human potential to grow and change.”
DeLuca will lead the educational component of the center, much of which will be presented online at the C-PROGRESS website in the form of a library of courses, workshops, webinars and demonstrations to train researchers in the design, conduct, analysis, and reporting of clinical trials. She hopes the center will attract investigators from diverse fields to pioneer new forms of treatment.
“I’ve gotten to know the children participating in our many clinical studies and watched their development into successful adulthood,” DeLuca said. “I’ve also seen how parents are filled with amazing ideas worthy of research as well as grounded advice for how clinicians can be responsive to their child’s total needs.”
Heathcock will lead the center’s technology component, including studying how to better assess children’s behavior in real world settings like home, school, and sports, complemented by lab measures.
Darragh, also at Ohio State University, will lead the center’s pilot studies program, which disperse up to $750,000 for small projects, or about $150,000 a year.
“We will promote ideas for rehabilitation that are a combination of bold, feasible, and far-reaching,” Darragh said. “We want to maximize the success of each pilot study so that the team can acquire large-scale funding for their ideas that demonstrate the greatest promise.”
Lo will organize opportunities for clinicians and scientists to have mentored collaborations with the C-PROGRESS senior scientists at both Ohio State and the Fralin Biomedical Research Institute.
Traditionally, many clinicians in pediatric neurology, physiatry – or physical medicine and rehabilitation – and developmental pediatrics have not had in-depth training or sufficient time to dedicate to conducting clinical trials.
“Clinical insights can be corralled into improving measurements in clinical trials to become more attuned to the full range of physical and mental needs of patients,” Lo said.
Craig Ramey will share the center’s expertise with national professional and advocacy organizations and private foundations. Ramey has previously led large interdisciplinary teams to address complex and pressing current health and social problems.
“There is nothing more important than bringing forth the full human potential of each and every child by applying all of our scientific knowledge,” Ramey said. “Pediatric medical rehabilitation is ready to move into the big leagues with team science.”