Trial Status: In Set-Up
Clinical effectiveness of an adolescent-specific strengthening programme, compared to usual care, for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomised controlled trial.
How effective is an individually tailored strengthening programme overseen by a physiotherapist compared to usual care in ambulant adolescents with cerebral palsy?
As children with cerebral palsy grow, they develop stiff and weak muscles. They often have difficulty walking and moving and that makes it difficult for them to join in different activities. Physiotherapy becomes a big part of their lives as it tries to train their muscles and help them participate in activities. When children reach their adolescent years, and their body grows bigger, the weakness of muscles in the legs becomes more of a challenge.
Strengthening exercises are one of the interventions used by physiotherapists in adolescents with Cerebral Palsy (CP). However, there is wide variability in the strengthening exercises used. Professional groups, such as the British Academy of Childhood Disability (BACD) Strategic Research Group, the British Society for Children’s Orthopaedic Surgery and a recent scoping review funded by NIHR HTA highlighted the need for evidence-based physiotherapy interventions in young people with CP. These should be deliverable through the NHS and focused on improving activity and participation in a child/young person and family friendly manner.
We have developed a new exercise programme to strengthen the leg muscles in adolescents with cerebral palsy, to assess if this is better at improving walking and ability to carry out daily activities, compared to usual physiotherapy exercises.
Aims and Objectives:
- Whether an individually tailored strengthening programme, including structured resistance exercises and advice, overseen by a physiotherapist over 16 weeks is more effective than usual care in improving functional mobility (measured using the GOAL questionnaire at 6 months) in ambulant adolescents with spastic CP.
- Is there any difference at 6 months in muscle strength and motor function (five-time sit-to-stand test and Timed up and Go test).
- Is there any differences at 12 months in functional mobility (measured using the GOAL questionnaire)
- Are there any differences at 6 and 12 months in the following: independence; balance; pain and discomfort; quality of life; educational outcomes; exercise adherence.
We plan to recruit 334 participants from at least 12 NHS secondary care clinics and their related physiotherapy services.
Participants will be randomised, via the Oxford Clinical Trials Research Unit randomisation service, to receive either:
- Progressive resistance exercise programme: an individually tailored strengthening programme, including structured resistance exercises and advice, overseen by a physiotherapist with 6 one-to-one sessions over 16 weeks.
- Usual NHS care: an assessment with a physiotherapist and advice on self-management, including access to supporting information and continuation of any usual fitness/physical activity programme (as applicable).
We hope the information we obtain from this trial will be used to help treat other children and young people with CP more effectively.