Multisite trial on efficacy of constraint-induced movement therapy in children with hemiplegia: study design and methodology.

OBJECTIVE: In the past decades, several treatment approaches have been used to improve upper limb function in hemiplegic cerebral palsy. Only recently has constraint-induced movement therapy emerged as a treatment approach for children with hemiplegic cerebral palsy with the aim of reversing the behavioral suppression of movement in the affected upper limb. To date, evidence on this treatment has been very poor and limited, because all currently available trials reveal methodological limitations and a need for additional research to support the application of this treatment technique. This article presents the methodological choices, design, and main characteristics of an ongoing controlled clinical trial on the effectiveness and safety of constraint-induced movement therapy combined with an intensive rehabilitation program and compared with two comparison groups: one treated with an intensive rehabilitation program and the other with standard treatment. METHODS: Twenty-one rehabilitation sites are currently recruiting patients with hemiplegic cerebral palsy, aged between 2 and 8 yrs, who have never undergone constraint therapy. Primary outcome measures include two major domains: upper limb motor ability (Quality of Upper Extremity Skills Test) and hand function assessment evaluating both grip function and spontaneous use of the affected side (Besta scale). Secondary outcome measures concern overall function, behavior, compliance, and satisfaction with treatment program of both child and family. Patients' follow-up is of 12 mos after treatment. RESULTS: Research in children has always been neglected in comparison with adults, because of ethical reasons regarding the use of children for experimental purposes. The consequence has been the utilization of treatment and assessment tools and techniques that have not always been tested in pediatric patients or evidence is very scarce. CONCLUSION: Discussing and working on pediatric research methods represents an urgent need in rehabilitation research.