AIM: Conventional constraint-based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using randomized trials. The aim of this study was to determine the effects of modified constraint-induced therapy compared with intensive occupational therapy on activities of daily living and upper limb outcomes in children with hemiplegic CP. METHOD: In this assessor-blinded pragmatic randomized trial, 50 children (27 males, 23 females; age range 19 mo to 7 y 10 mo) with hemiplegic CP were randomized using a concealed allocation procedure to one of two 8-week interventions: intensive occupational therapy (n = 25), or modified constraint-induced therapy (n = 25). Manual Ability Classification System (MACS) levels of the participants were, level I n = 2, II n = 37, III n = 8, and level IV n = 1; Gross Motor Function Classification System (GMFCS) levels were, level I n = 33, level II n = 15, and level III n = 1. Participants were recruited through three specialist CP centres in Australia and randomized between January 2008 and April 2010. Children randomized to modified constraint-induced therapy wore a mitt on the unaffected hand for 2 hours each day, during which time the children participated in targeted therapy. The primary outcome was the Canadian Occupational Performance Measure (COPM -- measured on a 10-point scale) at completion of therapy. Other outcome measures were Goal Attainment Scaling, Assisting Hand Assessment, Pediatric Motor Activity Log, Modified Ashworth Scale, Modified Tardieu Scale, and a parent questionnaire. Assessments were carried out at 10 weeks and 6 months following randomization. RESULTS: All participants were included in the analysis. Between-group differences for all outcomes were neither clinically important nor statistically significant. The mean difference in COPM was 0.3 (95% confidence interval (CI) -0.8 to 1.4; p = 0.61) and mean difference in COPM satisfaction was 0.1 (95% CI -1.1 to 1.2; p = 0.90). Minor adverse events were reported by five of the 25 participants in the modified constraint-induced therapy group and by one of the 25 in the intensive occupational therapy group. All adverse events were related to participants' lack of acceptance of therapy. INTERPRETATION: Modified constraint-induced therapy is no more effective than intensive occupational therapy for improving completion of activities of daily living or upper limb function in children with hemiplegic CP.

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