| Enrolling | Clinical Trial | Multi-site | StrokeNet NIH | Sharon L. Ramey & Warren Lo |
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol – I-ACQUIRE – to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). The proposed study is for children 8 to 24 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS. Clinical Trial Number: NCT03910075. More information: https://clinicaltrials.gov/ct2/show/NCT03910075
Participating Sites: Boston Children’s Hospital, Cincinnati Children’s Hospital Medical Center, Children’s Hospital of Philadelphia, C.S. Mott Children’s Hospital, Fralin Biomedical Research Institute at Virginia Tech, Martha Morehouse Medical Plaza, USCD Health La Jolla, Yale New Haven Children’s Hospital
Keyword (s): Perinatal Stroke, Neonatal Stroke, Rehabilitation, Cerebral Palsy, Pediatric Constraint-Induced Movement Therapy
