About the study
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.
Aim of the study
The aim of this study is to assess if an exercise programme to strengthen the muscles of young people with cerebral palsy is better than their usual physiotherapy treatment.
Enrolment curve
Recruitment target: 334 adolescents from approximately 12 sites in the UK
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
Core Trial Team
Tim Theologis
Co-Chief Investigator
Prof Tim Theologis is a Senior Research Fellow at Oxford University and an honorary Consultant Orthopaedic Surgeon at Oxford University Hospitals. He looks after children with orthopaedic conditions and is involved in the teaching of medical students, the supervision of postgraduate degrees and the training of orthopaedic residents. He has an active academic interest in children’s orthopaedics and is leading multi-centre clinical research studies.
Professor Sally Hopewell
Co-Chief Investigator
My key areas of research expertise are in the design, conduct and transparent reporting of randomized trials and systematic reviews. I am involved in leading the design and delivery of a number of clinical trials within the OCTRU portfolio. I am also co-chief investigator on the SPELL and ROBUST trials and on several other NIHR funded trials in the areas of rehabilitation and musculoskeletal sciences.
Catherine Barry
Paediatric Research Physiotherapist
I joined the Surgical Intervention Trials Unit (SITU-NDORMS) as a Paediatric Research Physiotherapist working on the SPELL and ROBUST trials. Funded by the NIHR Health Technology Assessment programme, the trials investigate the clinical effectiveness of physiotherapy interventions for children and young people with cerebral palsy.
After graduating with a BSc (Hons) in Physiotherapy from the University of Southampton in 1996, I specialised as a Paediatric Physiotherapist. I developed a specialist interest in the musculoskeletal management of cerebral palsy, including rehabilitation following lower limb multi-level orthopaedic surgery, working in both Melbourne and Oxford Children’s Hospital. My most recent clinical role was as an Extended Scope Physiotherapist (in paediatric neuro-orthopaedics), which I combined with the role of Children’s Musculoskeletal Therapy Team Lead at The Oxford University Hospitals NHS Foundation Trust.
Helen Wood
Physiotherapist (Research)
I joined SITU in 2023 as a research physiotherapist to work on the SPELL and ROBUST clinical trials. I continue to work clinically alongside this.
Prior to taking up this role I worked clinically in variety of sectors, specialising initially in Adult and Paediatric MSK. I completed an MSc in Paediatric Physiotherapy at UCL before moving to Oxford where I spent time working in both the paediatric acute, and MSK/orthopaedic teams. Here, I was fortunate to complete a research internship, funded by the Oxford Biomedical Research Centre.
Jo O’Mahoney
Clinical Trial Manager
I joined SITU in November 2021 to work as a trial manager on the paediatric orthopaedic CPinBOSS study. CPinBOSS is a cohort study measuring the number of patients with cerebral palsy eligible for single event multi level surgery (SEMLS) in the UK. This study is led by Chief Investigator Tim Theologis and is now in follow up. In addition, I have recently started working on the set up of another paediatric study investigating the role of USS and MRI in diagnosing bone infection - PIC Bone, which is also led by Tim Theologis and Dan Perry (joint Chief Investigators).
My background is in psychology in which I have achieved a BSc (Hons) degree, followed by a MSc in Foundations of Clinical Psychology in 2008. I then worked as a research worker on a number of mental health research projects at St George's University of London and King's College Institute of Psychiatry before I returned to my hometown of Oxford where I joined NDORMS in 2014 as a research coordinator. In this role I assisted with the set up and delivery of both adult and paediatric musculoskeletal research projects. This is where I discovered my passion for paediatric orthopaedic research, leading me to my current role.
Megan Stone
Clinical Trials Coordinator
I joined the SITU team as a Clinical Trial Assistant, after gaining experience as a Junior Project Manager at The Oxford Vaccine Group.
My current role in the SITU team is a Clinical Trial Coordinator, working on the following trials: SPELL, ROBUST and PIC Bone.
Prior to working at SITU and OVG, I gained my BSc in Biological Science at The University of Reading and have previous experience as a Laboratory Technician.
Co-Applicants
- Prof Tim Theologis (University of Oxford)
- Prof Sally Hopewell (University of Oxford)
- Prof Jeremy Parr (Newcastle University)
- Dr Morag Andrew (Newcastle upon Tyne NHS Foundation Trust)
- Dr David Keene (University of Exeter)
- Dr Jennifer Ryan (Royal College of Surgeons in Ireland)
- Dr Lesley Katchburian (UCL Great Ormond Street Institute of Child Health)
- Mrs Rachel Rapson (Torbay and South Devon NHS Foundation Trust)
- Dr Ines Rombach (Sheffield University)
- Dr Beth Fordham (University of Oxford)
- Mr Gregory Firth (Royal London Hospital)
- Prof Daniel Perry (University of Liverpool)
- Ms Vivi Gregory-Osborne (Patient and Public Contributor)
- Mrs Helen Gregory-Osborne (Patient and Public Contributor)
Current research management team
- Loretta Davies
- Sian Saul
- Heidi Fletcher