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Randomized Controlled Trial
Effects of botulinum toxin A in ambulant adults with spastic cerebral palsy: a randomized double-blind placebo controlled-trial.
- Grethe Maanum, Reidun Jahnsen, Johan K Stanghelle, Leiv Sandvik, and Anne Keller.
- Sunnaas Rehabilitation Hospital, Bjørnemyr, Nesoddtangen, Norway. grethe.manum@sunnaas.no
- J Rehabil Med. 2011 Mar 1; 43 (4): 338-47.
ObjectiveThis study aimed to assess short-term effects of botulinum toxin A in ambulant adults with spastic cerebral palsy.DesignA single-centre double-blind, placebo-controlled, randomized clinical trial.SubjectsPatients 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.MethodsA 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.ResultsNo 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.ConclusionBotulinum 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.
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