Multicenter randomized controlled trial of pediatric constraint-induced movement therapy: 6-month follow-up.

OBJECTIVE: Pediatric constraint-induced movement therapy (CIMT) is a promising intervention for children with unilateral cerebral palsy (CP). This multisite randomized controlled trial (RCT) tested the hypothesis that 6 hr versus 3 hr per day for 21 days would produce larger maintenance of gains 6 mo posttreatment. METHOD: Three sites recruited 18 children (6 per site) ages 3-6 yr with unilateral CP. Children were randomly assigned 3 to 6 hr/day of CIMT for 21 days and wore a cast on the unaffected extremity the first 18 days. Occupational therapists applied a standardized pediatric CIMT protocol. Evaluators blinded to condition administered the ASsisted Hand Assessment and the Quality of Upper Extremity Skills Test, and parents completed the Pediatric Motor Activity Log pre- and posttreatment (1 wk, 1 mo, and 6 mo). RESULTS: Both CIMT dosage groups showed significant gains on all five assessments with no significant group differences at 6 mo follow-up. Effect sizes (n = 15) comparing preintervention to postintervention measures (partial η2) ranged from .33 to .80. CONCLUSION: The first multisite RCT of pediatric CIMT confirmed the maintenance of positive effects at 6 mo follow-up across multiple functional performance measures. The hypothesis that maintenance of effects would differ for children who received 6 versus 3 hr/day of CIMT (126 vs. 63 total hr) was not supported.