The proposed project tests the principle that frequency of rehabilitation is an important regulator of therapeutic response in infants.
We will randomize 75 infants with cerebral palsy, 6 to 24 months of age and/or Gross Motor Function Classification System levels III to V (higher severity), to determine the short-term and long-term effects of 3 dosing protocols consisting of an identical number of 2-hour sessions of the same motor learning-based therapy applied over a different total number of calendar weeks.
The results will inform clinicians, families, and scientists about dosing and will provide needed recommendations for frequency of rehabilitation to optimize motor function and development of young children with cerebral palsy.
The proposed project tests a hypothesis that frequency of rehabilitation is an important regulator of therapeutic response in infants and does not test the efficacy of a type of treatment.
Nationwide Children's Hospital (Drs Ferrante, Hendershot, Baranet, Maitre, and Lo), Columbus, Ohio; The Ohio State University (Drs Barbosa, Pan, and Heathcock), Columbus, Ohio; Kettering College (Dr Carey), Kettering, Ohio
Correspondence: Jill Heathcock, PT, PhD, The Ohio State University, 516 Atwell Hall, 453 W. 10th Ave, Columbus, OH 43210 (email@example.com).
The study protocol was approved by Nationwide Children's Hospital IRB (IRB15-01025). This trial has been registered at clinicaltrials.gov (NCT02857933). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
Grant Support: This project is funded by the NIH 5R01HD083384 (PI and corresponding author: Heathcock), is registered at clinicaltrials.gov NCT02857933, and has IRB approval from Nationwide Children's Hospital IRB15-01025.
The authors declare no conflicts of interest.