Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy

Background-Cerebral palsy is the commonest cause of severe physical disabil ity in childhood. For many years treatment has centred on the use of physio therapy and orthotics to overcome the problems of leg spasticity, which int erferes with walking and can lead to limb deformity. Intramuscular botulinu m toxin (BT-A) offers a targeted form of therapy to reduce spasticity in sp ecific muscle groups. Aims-To determine whether intramuscular BT-A can improve walking in childre n with cerebral palsy. Design-Randomised, double blind, placebo controlled trial. Methods-Forty patients with spastic diplegia or hemiplegia were enrolled. T wenty two received botulinum toxin and 18 received placebo. The primary out come measure was video gait analysis and secondary outcome measures were gr oss motor function measure (GMFM), physiological cost index (PCI), and pass ive ankle dorsiflexion. Results-Video gait analysis showed clinically and statistically significant improvement in initial foot contact following BT-A at six weeks and 12 wee ks compared to placebo. Forty eight per cent of BT-A treated children showe d clinical improvement in VGA compared to 17% of placebo treated children. The GMFM (walking dimension) showed a statistically significant improvement in favour of the botulinum toxin treated group. Changes in PCI and passive ankle dorsiflexion were not statistically significant. Conclusion-The study gives further support to the use of intramuscular botu linum toxin type A as an adjunct to conventional physiotherapy and orthoses to reduce spasticity and improve functional mobility in children with spas tic diplegic or hemiplegic cerebral palsy.