An RCT to determine the optimum frequency of Botulinum Toxin injections to the calf in children with cerebral palsy [ 2007 - 2012 ]

Research Grant

Researchers: Prof Herbert Graham (Principal investigator) ,  A/Pr Barry Rawicki ,  Prof Richard Baker

Brief description Cerebral Palsy (CP) is the most common cause of disability amongst children across the developed world. There are about 1800 children with CP in Victoria alone. It is caused by damage to the brain in early childhood. Children with CP have difficulty controlling how their muscles work. Muscles are often spastic, which means that they are switched on all the time, and this makes walking and performing other tasks difficult. As the child grows the spastic muscles can become too short and this occurs can only be corrected by orthopaedic surgery. The spasticity in particular muscles can be reduced by injecting them with Botulinum Toxin (commonly known as Botox and used cosmetically to remove wrinkles). The effects of a single injection have been closely studied and we know that the effect of the toxin wears off. Children are thus offered repeat injections but there have been no studies to investigate what is the most appropriate interval between injections. The aim of this study is to determine this. In routine clinical practice children tend to get injections approximately once a year. A consideration of what we know about how the toxin acts, however, suggests that injections every 4 months might be expected to be more effective. This study will thus randomly allocate children to receive injections either every twelve months or every four months over a two year period. During the study both groups will be monitored to see if there are differences in how easily they can walk and perform other functions and in their overall quality of life. After the study the children will also be assessed to see whether there is any difference in the length of the spastic muscles. There have been no other studies to investigate the most appropriate interval between injections. This study will thus be the first anywhere and will be the foundation for guidelines for the ongoing use of botulinum toxin in children with cerebral palsy in Australia and throughout the world.

Funding Amount $AUD 286,358.30

Funding Scheme NHMRC Project Grants

Notes Standard Project Grant