Objectives
Perinatal arterial ischemic stroke occurs in 1:2500-1:7700 live births with more than 3400 new cases/year in the US and carries a high risk of long-term motor and cognitive impairment, especially hemiparesis. There has previously been no consensus on rehabilitation practices for infants with perinatal arterial ischemic stroke (PAS), but in older children with hemiparesis, constraint-induced movement therapy (CIMT) has proven efficacious. I-ACQUIRE is a specific form of CIMT. The primary aim of this study is to determine the efficacy of I-ACQUIRE on upper extremity skills in the hemiparetic side in children less than 36 months of age with PAS and resulting hemiparesis using the I-ACQUIRE protocol at 2 dosage levels compared to usual and customary treatment. The secondary aim is to determine the efficacy of I-ACQUIRE on the use of the hemiparetic upper extremity in bimanual activities.

Design
This study is a prospective multicenter phase III randomized controlled trial. 240 children will be enrolled, randomized and treated between 8 and 36 months of life.

Procedures
Children meeting enrollment criteria of PAS diagnosis with confirmatory MRI and resulting hemiparesis will be randomized 1:1:1 to either moderate dose I-ACQUIRE therapy (3 hours/day, 5 days/week), high dose I-ACQUIRE therapy (6 hours/day, 5 days/week) or usual and customary treatment for 4 weeks. There are currently 14 sites actively enrolling or approved to enroll and to date, 65 children have been enrolled.

Outcomes
Blinded video assessments and parent rating scales will be obtained at baseline (pre-treatment), immediately upon therapy completion and 6 months post-completion. Changes in the Emerging Behaviors Scale (EBS) will be used to assess upper extremity skills in the hemiparetic side and the Mini-Assisting Hand Assessment (mini-AHA) will be used to measure the hemiparetic upper extremity use in bimanual activities.