title: Intensive therapy following upper limb botulinum toxin A injection in young children with unilateral cerebral palsy: a randomized trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  In this randomized, controlled, evaluator-blinded trial, 34 children (20 males, 14 females; mean age 3y, SD 1y 4mo, range 18mo-6y) 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] 0.7-5.2; BONT-A + BOT: EMD 4.7, 95% CI 2.1-8.6). Follow-up at 6 months also demonstrated no superior effect for BoNT-A + mCIMT.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Occupational Therapy, La Trobe University, Bundoora, Australia.
authors.forename: Brian
authors.initials: B
authors.lastname: Hoare
authors.forename: Christine
authors.initials: C
authors.lastname: Imms
authors.forename: Elmer
authors.initials: E
authors.lastname: Villanueva
authors.forename: Hyam Barry
authors.initials: HB
authors.lastname: Rawicki
authors.forename: Thomas
authors.initials: T
authors.lastname: Matyas
authors.forename: Leeanne
authors.initials: L
authors.lastname: Carey
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000627:therapeutic use; D002547:Cerebral Palsy / Q000188:drug therapy / Q000534:rehabilitation / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D005080:Exercise Test; D005081:Exercise Therapy / Q000379:methods*; D006429:Hemiplegia / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D007223:Infant; D007267:Injections; D008297:Male; D009483:Neuropsychological Tests; D009788:Occupational Therapy / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology*
chemical_list: D019274:Botulinum Toxins, Type A