Principal Investigators Rich Stevenson, M.D., of the University of Virginia (UVA) and Paul Gross of the Cerebral Palsy Research Network (CPRN) and their study team finalized the details for what will be the largest cerebral palsy study ever conducted in the U.S. The study team and site investigators have been hard at work to complete this Herculean effort to apply to the Patient-Centered Outcomes Research Institute (PCORI) for a 23 center study. The Study Executive Team includes:
|Diane Damiano, Ph.D.||National Institute of Health Clinical Center||Co-Investigator|
|Paul Gross||Cerebral Palsy Research Network||Dual Principal Investigator|
|Susan Horn, Ph.D.||University of Utah||Co-Investigator|
|Jacob Kean, Ph.D.||University of Utah||Co-Investigator|
|Unni Narayanan, M.D., M.P.H.||SickKids/Holland Bloorview||Co-Investigator|
|Garey Noritz, M.D.||Nationwide Children’s Hospital||Co-Investigator|
|Jerry Oakes, M.D.||Children’s of Alabama||Co-Investigator|
|Michele Shusterman||CP Daily Living/CP NOW Foundation||Co-Investigator|
|Richard Stevenson, M.D.||University of Virginia||Dual Principal Investigator|
The primary goal is to determine the effectiveness of surgical interventions for ambulatory children with CP to improve gait function as measured by child and parent reported outcomes that align with family goals when compared to standard non-surgical interventions. Our secondary goal is to change practice by identifying patient and surgical details that will help clinicians and parents choose the right treatment for the right child at the right time.
The Specific Aims are to:
- Compare effectiveness of orthopedic surgery, selective dorsal rhizotomy (SDR), neurotoxin injection, and physical therapy (PT) alone in improving outcomes in patients ages 3-12 with bilateral spastic cerebral palsy;
- Describe and compare adverse events associated with each treatment option;
- Explore intervention characteristics associated with positive or negative outcomes controlling for patient factors.
The study executive team appreciates the efforts of the site investigators and their grants administration teams and the patient and stakeholder partners. In addition, special recognition goes to the UVA grants administration team of Kerry Day, Michelle Haynes and Angela Rogers and University of Utah biostatistician Tom Greene for making this application possible. We look forward to a positive affirmation of our work from PCORI in early 2017!