About the Study
Assessing clinical and cost-effectiveness of prehabilitation combined with usual NHS care compared to usual NHS care alone in children undergoing elective lower limb orthopaedic surgery.
Primary objective
To assess whether a 45-minute prehabilitation session, delivered in clinic approximately six weeks before surgery, in addition to usual NHS care, improves functional mobility compared to usual care alone.
Our primary outcome is functional mobility, assessed using the PROMIS-Computer Adaptive Test (CAT) Mobility Score for Children (MSC), measured two weeks post-operatively.
CORE trial team
Marie-Caroline Nogaro
Chief Investigator
Consultant Paediatric Orthopaedic Surgeon, Clinical Research Fellow in Paediatric Orthopaedics
Tim Theologis
Co-Chief Investigator
Associate Professor, Honorary Consultant Orthopaedic Surgeon
Catherine Barry
Co-Chief Investigator
Paediatric Research Physiotherapist
Loretta Davies
SITU Trials Portfolio Manager (Operational Lead)
Megan Stone
Clinical Trial Manager
Heidi Fletcher
SITU Senior Data Manager
Additional team members
Co-applicants
- Miss Clare Carpenter, Cardiff and Vale University Health Board
- Prof Daniel Perry, University of Liverpool
- Dr Elizabeth Conroy, University of Oxford
- Dr José Leal, University of Oxford
- Dr Loretta Davies, University of Oxford
- Ms Mariea Brady, Oxford University Hospitals NHS FT
- Phillipa Rooney, Patient and Public Contributors
- Prof Sally Hopewell, University of Oxford
- Dr Susanne Arnold, University of Warwick
- Prof Toby Smith, University of Warwick
- Ms Elizabeth Lotinga, Norfolk and Norwich University Hospitals NHS FT
Enrolment curve
Recruitment target: 524
Information about the study
Participants & setting
We aim to recruit 524 participants (262 per group) from paediatric orthopaedic surgery waiting lists across at least 20 UK NHS Trusts.
Treatment
Participants will be individually randomised (1:1) to receive either a 45-minute session of prehabilitation in addition to usual care, or usual care alone.
Timescale for delivery
Overall planned end date for recruitment: 31 May 2028.
Outcome measure
Our primary outcome is functional mobility, assessed using the PROMIS-Computer Adaptive Test (CAT) Mobility Score for Children (MSC), measured two weeks post-operatively.
Study design
Pragmatic, superiority, parallel group, multicentre randomised controlled trial with an embedded internal pilot, integrated process evaluation and economic analysis.
Funder & sponsor
The trial is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme. The sponsor is University of Oxford, Research Governance, Ethics & Assurance Team.