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Intensive therapy following upper limb Botulinum Toxin A injection in young children with unilateral cerebral palsy: a randomized trial [with consumer summary]
Hoare B, Imms C, Villanueva E, Rawicki HB, Matyas T, Carey L
Developmental Medicine and Child Neurology 2013 Mar;55(3):238-247
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: Botulinum Toxin A (BoNT-A) combined with occupational therapy is effective in improving upper limb outcomes in children with unilateral cerebral palsy (CP). It is now essential to identify the most effective therapies following BoNT-A. Given the added burden for children and families, the aim of this study was to explore whether modified constraint-induced movement therapy (mCIMT) leads to sufficiently superior gains compared with bimanual occupational therapy (BOT) in young children with unilateral CP following BoNT-A injections. METHOD: In this randomized, controlled, evaluator-blinded trial, 34 children (20 males, 14 females; mean age 3 y, SD 1 y 4 mo, range 18 mo to 6 y) with unilateral CP were randomized using concealed allocation to one of two 8-week interventions. The experimental group (n = 17) received BoNT-A and mCIMT. The comparison group (n = 17) received BoNT-A and BOT. Participants were recruited from a physical rehabilitation clinic and randomized between August 2003 and May 2009. Primary outcome was measured using the Assisting Hand Assessment at 3 months. Secondary outcomes were measured at 3 months and 6 months using the Quality of Upper Extremity Skills Test, the Pediatric Evaluation of Disability Inventory, Canadian Occupational Performance Measure, and the Goal Attainment Scale. RESULTS: There were no clinically important differences between groups at baseline. Immediately following intervention, there was no evidence of a superior effect for BoNT-A+mCIMT as determined by the Assisting Hand Assessment (estimated mean difference (EMD) 0.81, upper 95% confidence limit 3.6; p = 0.32) or secondary outcomes. However, both groups showed improvement over time (BoNT-A+mCIMT EMD 2.7, 95% confidence interval (CI) 0.7 to 5.2; BONT-A+BOT EMD 4.7, 95% CI 2.1 to 8.6). Follow-up at 6 months also demonstrated no superior effect for BoNT-A+mCIMT. INTERPRETATION: Following upper limb injection of BoNT-A, there was no evidence that mCIMT, despite the significantly increased intensity of the home programme, produced a superior effect across a range of outcomes compared with a structured programme of BOT in young children with unilateral CP.

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