Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Each year, an estimated 3400+ infants in the U.S. experience PAS and have a high likelihood of lifelong impairment in neuromotor and often cognitive functioning, resulting in a high cost burden for families, the healthcare system, and society. If I-ACQUIRE proves efficacious, then the field will have the critically needed Phase III confirmatory evidence and the specific clinical protocol needed to transform rehabilitation and improve clinical outcomes and quality of life for infants with PAS.
This is a multi-site trial comparing 2 dosages of a form of intensive pediatric rehabilitation known as Infant ACQUIRE (I-ACQUIRE) to Usual and Customary treatment (U&CT). I-ACQUIRE will be used to treat 8 – 36-month-old children with PAS in either 3 hours/day (Moderate Dose) or 6 hours/day (High Dose) for 5 days/week for 4 weeks. For each child, treatment goals are set with parents who also participate in daily home practice (about 45 minutes/day) with their child. I-ACQUIRE includes all of the core features of pediatric Constraint-Induced Movement Therapy (CIMT).
Your infant or toddler may be eligible if he or she:
- Had a stroke in the newborn period or was thought to have had a stroke even before birth.
- Shows motor weakness or poor control of movements on one side of the body (often diagnosed as hemiparesis).
- Will be between 8 and 36 months old when treatment is received.
- Program staff can speak with you to review all eligibility requirements in detail.
I-ACQUIRE is a form of infant and toddler rehabilitation. Two dosages are being evaluated compared with the treatments that infants and toddlers with hemiparesis typically receive. Both dosages of I-ACQUIRE therapy involve 5 days a week for 4 weeks in a row, provided by a therapist trained in I-ACQUIRE. The general name for this form of therapy is constraint-induced movement therapy (CIMT).
Your child will be assigned by chance to 1 of 3 groups:
Group 1: I-ACQUIRE 6 hours daily, 5 days per week for 4 weeks.
Group 2: I-ACQUIRE 3 hours daily, 5 days per week for 4 weeks.
Group 3: Continue the current therapy your child normally receives. Six months later participants in this group can choose to be assigned by chance to the high or low dose of I-ACQUIRE therapy.