title: Botulinum toxin A for nonambulatory children with cerebral palsy: a double blind randomized controlled trial.
abstract: OBJECTIVE
  To examine the efficacy and safety of intramuscular botulinum toxin A (BoNT-A) to reduce spasticity and improve comfort and ease of care in nonambulant children with cerebral palsy (CP).
  
  
  METHODS
  Nonambulant children with CP (n = 41; Gross Motor Function Classification System level IV = 3, level V = 38; mean age 7.1 years, range 2.3-16 years, 66% male) were randomly allocated to receive either intramuscular BoNT-A injections (n = 23) or sham procedure (n = 18) combined with therapy. The analysis used generalized estimating equations with primary outcome the Canadian Occupational Performance Measure (COPM) at 4 weeks postintervention and retention of effects at 16 weeks. Adverse events (AE) were collected at 2, 4, and 16 weeks by a physician masked to group allocation.
  
  
  RESULTS
  There were significant between group differences favoring the BoNT-A-treated group on COPM performance at 4 weeks (estimated mean difference 2.2, 95% CI 0.8, 3.5; P = .002) and for COPM satisfaction (estimated mean difference 2.2, 95% CI 0.5, 3.9; P = .01). These effects were retained at 16 weeks for COPM satisfaction (estimated mean difference 1.8, 95% CI 0.1, 3.5; P = .04). There were more mild AE at 4 weeks for the BoNT-A group (P = .002), however, there were no significant between-group differences in the reporting of moderate and serious AE.
  
  
  CONCLUSIONS
  In a double-blind randomized sham-controlled trial, intramuscular BoNT-A and therapy were effective for improving ease of care and comfort for nonambulant children with CP. There was no increase in moderate and severe AE in the children who had BoNT-A injections compared with the sham group.
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia. Electronic address: Lisa_copeland@health.qld.gov.au.
authors.forename: Lisa
authors.initials: L
authors.lastname: Copeland
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Priya
authors.initials: P
authors.lastname: Edwards
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Megan
authors.initials: M
authors.lastname: Thorley
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Samantha
authors.initials: S
authors.lastname: Donaghey
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Laura
authors.initials: L
authors.lastname: Gascoigne-Pees
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Megan
authors.initials: M
authors.lastname: Kentish
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Grad
authors.initials: G
authors.lastname: Cert
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Jayne
authors.initials: J
authors.lastname: Lindsley
authors.affiliation: Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Kim
authors.initials: K
authors.lastname: McLennan
authors.affiliation: Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Leanne
authors.initials: L
authors.lastname: Sakzewski
authors.affiliation: Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
authors.forename: Roslyn N
authors.initials: RN
authors.lastname: Boyd
mesh_terms: D000293:Adolescent; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000188:drug therapy* / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009128:Muscle Spasticity / Q000188:drug therapy; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009788:Occupational Therapy / Q000379:methods; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A