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 disability in childhood. For many years treatment has centred on the use of physiotherapy and orthotics to overcome the problems of leg spasticity, which interferes with walking and can lead to limb deformity. Intramuscular botulinum toxin (BT-A) offers a targeted form of therapy to reduce spasticity in specific muscle groups.


OBJECTIVE
To determine whether intramuscular BT-A can improve walking in children with cerebral palsy.


METHODS
Randomised, double blind, placebo controlled trial.


METHODS
Forty patients with spastic diplegia or hemiplegia were enrolled. Twenty two received botulinum toxin and 18 received placebo. The primary outcome measure was video gait analysis and secondary outcome measures were gross motor function measure (GMFM), physiological cost index (PCI), and passive ankle dorsiflexion.


RESULTS
Video gait analysis showed clinically and statistically significant improvement in initial foot contact following BT-A at six weeks and 12 weeks compared to placebo. Forty eight per cent of BT-A treated children showed 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.


CONCLUSIONS
The study gives further support to the use of intramuscular botulinum toxin type A as an adjunct to conventional physiotherapy and orthoses to reduce spasticity and improve functional mobility in children with spastic diplegic or hemiplegic cerebral palsy.
Ubhi
T
T
Academic Department of Paediatrics and Child Health, University of Leeds, UK. Medbsu@Leeds.ac.uk
Bhakta
B B
BB
Ives
H L
HL
Allgar
V
V
Roussounis
S H
SH
D000293:Adolescent; D000843:Ankle Joint / Q000503:physiopathology; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005684:Gait / Q000187:drug effects; D006801:Humans; D007223:Infant; D008297:Male; D009068:Movement / Q000187:drug effects; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014743:Videotape Recording; D016138:Walking
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A