Baker, RJ, Jasinski, M, Maciag-Tymecka, I, Michalowska-Mrozek, J, Bonikowski, M, Carr, L, MacLean, J, Lin, JP, Lynch, B, Theologis, T, Wendorff, J, Eunson, P and Cosgrove, A
'Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomised, double-blind, placebo-controlled, dose-ranging study'
, Developmental Medicine and Child Neurology, 44 (10)
, pp. 666-675.
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°, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.
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