Irish Child Health Database - Peer Reviewed Papers
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Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study
Published in:
Dev Med Child Neurol, Vol: 44, Page: 666-75
Publication Date:
October 2002
Aims & Objectives:
The aim of this study was to assess the efficacy and safety of three doses of botulinum toxin A (BTX-A; Dysport) in 125 patients with dynamic equinus spasticity during walking.
Abstract:
This study evaluated the efficacy and safety of three doses of botulinum toxin A (BTX-A; Dysport) in 125 patients (mean age 5.2 years, SD 2; 54% male)with dynamic equinus spasticity during walking. Participants were randomized to receive Dysport (10, 20, or 30 units/kg) or placebo to the gastrocnemius muscle of both legs. Muscle length was calculated from electrogoniometric measurements and the change in the dynamic component of gastrocnemius shortening at four weeks was prospectively identified as the primary outcome measure. All treatment groups showed statistically significant decreases in dynamic component compared with placebo at 4 weeks. Mean improvement in dynamic component was most pronounced in the 20 units/kg group, being equivalent to an increase in dorsiflexion with the knee extended at 19 degrees, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.
Authors:
Study Type:
Study Papers » A randomized controlled trial » Descriptive Studies - Studies with a health technology dimension
Categories:
botulinum toxin A in the treatment of muscle spasms
International Classification:
Evaluation of the effectiveness of treatment - dynamic equinus spasticity
Keywords:
- Botulinum Toxin Type A/ administration & dosage/adverse effects
- Cerebral Palsy/diagnosis/ drug therapy
- Child
- Child, Preschool
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Injections, Intramuscular
- Male
- Muscle Spasticity/diagnosis/ drug therapy
- Muscle, Skeletal/drug effects
- Neurologic Examination/drug effects
- Treatment Outcome
- walking
Geography:
Northern Ireland (Northern Ireland)

