title: Effects of botulinum toxin A in ambulant adults with spastic cerebral palsy: a randomized double-blind placebo controlled-trial.
abstract: OBJECTIVE
  This study aimed to assess short-term effects of botulinum toxin A in ambulant adults with spastic cerebral palsy.
  
  
  METHODS
  A single-centre double-blind, placebo-controlled, randomized clinical trial.
  
  
  METHODS
  Patients were recruited through advertisements. Inclusion criteria were: spastic cerebral palsy, age 18-65 years, decreased walking, walking without aids for minimum 20 m, and no cognitive impairments.
  
  
  METHODS
  A total of 66 participants, mean age 37 (standard deviation 11.4) years, were enrolled and received injections of either botulinum toxin A (n=33) or placebo (n=33). Primary outcomes were: sagittal kinematics of ankle, knee and hip, and health-related quality of life (Short Form 36). Secondary outcomes were: visual analogue scale for muscle-stiffness/spasticity, Timed Up and Go, 6-minute walk test, and Global Scale of perceived effect.
  
  
  RESULTS
  No significant differences were found between the groups in the primary outcomes. In the secondary outcomes the botulinum toxin A group rated improvement in visual analogue scale muscle-stiffness/spasticity and the Global Scale of perceived effect. No serious adverse events occurred.
  
  
  CONCLUSIONS
  Botulinum toxin A injections alone gave no benefit over placebo in lower limb sagittal kinematics and Short Form 36 in ambulatory adults with cerebral palsy. However, self-reported rating of muscle-stiffness/spasticity and global effects indicated positive effects of botulinum toxin A. Further studies with specific post-injection rehabilitation and longer study period are warranted.
authors.affiliation: Sunnaas Rehabilitation Hospital, Bjørnemyr, Nesoddtangen, Norway. grethe.manum@sunnaas.no
authors.forename: Grethe
authors.initials: G
authors.lastname: Maanum
authors.forename: Reidun
authors.initials: R
authors.lastname: Jahnsen
authors.forename: Johan K
authors.initials: JK
authors.lastname: Stanghelle
authors.forename: Leiv
authors.initials: L
authors.lastname: Sandvik
authors.forename: Anne
authors.initials: A
authors.lastname: Keller
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000188:drug therapy* / Q000503:physiopathology / Q000534:rehabilitation; D004311:Double-Blind Method; D005260:Female; D005684:Gait / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D057566:Self Report; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A