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Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double‐blind, placebo‐controlled, dose‐ranging study
Author(s) -
Baker R,
Jasinski M,
MaciagTymecka I,
MichalowskaMrozek J,
Bonikowski M,
Carr L,
MacLean J,
Lin JP,
Lynch B,
Theologis T,
Wendorff J,
Eunson P,
Cosgrove A
Publication year - 2002
Publication title -
developmental medicine and child neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.658
H-Index - 143
eISSN - 1469-8749
pISSN - 0012-1622
DOI - 10.1111/j.1469-8749.2002.tb00268.x
Subject(s) - spasticity , placebo , botulinum toxin , medicine , cerebral palsy , gastrocnemius muscle , anesthesia , dose ranging study , randomized controlled trial , physical medicine and rehabilitation , double blind , physical therapy , surgery , skeletal muscle , alternative medicine , pathology
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 1920, and was still present at 16 weeks. The safety profile of the toxin appears satisfactory.