Effects of Botulinum Toxin a in Ambulant Adults with Spastic Cerebral Palsy: A Randomized Double-Blind Placebo-Controlled Trial
Design: A single-centre double-blind, placebo-controlled, randomized clinical trial.
Subjects: 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.
Conclusion: 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.
Document Type: Research Article
Publication date: 01 March 2011
Journal of Rehabilitation Medicine is the international peer-reviewed journal published in English, with at least 10 issues published per year.
Original articles, reviews, case reports, short communications, special reports and letters to the editor are published, as also are editorials and book reviews. The journal strives to provide its readers with a variety of topics including: functional assessment and intervention studies, clinical studies in various patient groups, methodology in physical and rehabilitation medicine, epidemiological studies on disabling conditions and reports on vocational and sociomedical aspects of rehabilitation.
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