Taking part
This page explains the ROBUST Study for people who might be interested in joining.
General information
We have developed a new exercise programme, using resistance exercises, to strengthen the leg muscles in young people with CP. We have also tried to make the exercise programme interesting and fun so that young people will be happy to follow it for a long time.
The aim of this study is to assess if a specific exercise programme to strengthen the muscles of young people with cerebral palsy is better at improving walking and their ability to carry out daily activities, compared to usual physiotherapy exercises.
Participant Information
If you are considering taking part in the ROBUST study, please follow the link below to open the ROBUST Participant Information Tool. Here you can view the key information needed to decide whether to take part.
Information about the Study
Study Design
A multi-centre, two arm, parallel design, superiority, randomised controlled trial. The participants will be individually randomised (1:1) to receive either a strengthening intervention programme or usual NHS care.
Target population
Adolescents from 12 to 18 years of age (i.e. from their 12th to their 18th birthday) with a diagnosis of spastic cerebral palsy (bilateral or unilateral) Gross Motor Function Classification System (GMFCS) levels I–III who are able to comply with assessment procedures and exercise programme with or without support from their carer.
Study Funder and Sponsor
The trial is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme. The sponsor is University of Oxford, Research Governance, Ethics & Assurance Team (RGEA).
Intervention
Progressive resistance exercise programme: Participants receive an individually tailored strengthening programme, including structured resistance exercises and advice, overseen by a physiotherapist with 6 one-to-one sessions over 16 weeks.
Timescales
Planned trial period is 44 months.
Recruitment is expected to last for 20 months.
Outcome Measures
Functional mobility at 6 months measured using the patient/parent reported GOAL (Gait Outcomes Assessment List) questionnaire