Extract

Background and study aims Cerebral palsy (CP) is a common cause of disability in childhood, affecting approximately 2.5 children per 1000. A large number (up to 80%) of these children have difficulty using their upper limbs. This has a major impact on children's developmental opportunities. Treatment of children with CP focuses on physiotherapy and occupational therapy, supported more recently by botulinum treatment. Therapy involves exercises and repetitive functional movements often guided by hands-on assistance, a regime not popular with the children. Botulinum is an anti-spasticity treatment that allows targeting of specific muscles, aiding improvements in the quality of therapy, but there is only a small window of opportunity before the effects wear off. It is difficult for therapists to provide timely support of sufficient quantity, given the stretched resources of NHS therapy departments. We have designed and produced a computer games system for children with cerebral palsy, played using a robotic arm (like a joystick, but with motors that provide guidance and assistance) to support and assist the children's hand directions when playing the games. The games encourage exercise while providing the extra dimension of fun. Initial studies indicated that children enjoy playing the games, and also showed that there were improvements in upper limb activity. The games are simple but children do need sufficient ability to understand the games and concept of using the joystick/robotic arm. This study aims to evaluate whether the use of a home-based computer-assisted arm rehabilitation games system has functional benefits of botulinum. Who can participate? The study involves children with cerebral palsy aged 5 - 12 years old who have sufficient understanding to be able to play simple computer games, who have voluntary arm movements and who have had botulinum treatment for the upper limb. What does the study involve? Children are randomly allocated into a control group (no computer games system) and an intervention group (receives a home-based computer games system for 6 weeks after botulinum treatment). Both groups receive follow up support (e.g. occupational therapy, orthotic splinting etc) as normal. Before the children receive botulinum (and before their group allocation), their arm ability is assessed using two measures which are validated and reliable for use with children with cerebral palsy. They also check the quality of their hand movements (hand speed, accuracy and smoothness of movements). Between six and seven weeks after receiving botulinum treatment, and again at twelve weeks, both groups are measured in exactly the same way again. We expect all children to show an improvement because they have all received botulinum for reduction of spasticity but we will examine the measurements to see if those children who played the computer-assisted arm rehabilitation games system have improved significantly more than those who were in the control group. What are the possible benefits and risks of participating? There is no strong evidence that participating will benefit the children, although we hope to find that children fortunate enough to receive a games system will show greater improvements in arm activity. There is a risk that the unaccustomed arm use caused by playing the game might cause muscle aching. Where is the study run from? The study is being managed and conducted by researchers at the School of Medicine and the School of Mechanical Engineering at the University of Leeds, UK. When is the study starting and how long is it expected to run for? The study will finish recruitment in July 2014. It has been underway since June 2013. Who is funding the study? The study is funded by the National Institute for Health Research (NIHR) through a Clinical Doctoral Research Fellowship, UK. Who is the main contact? Mr Nick Preston [email protected]

Inclusion criteria

• Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics

Links

• ictrp
• isrctn