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Clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic cerebral palsy (ROBUST trial): a parallel group randomized controlled trial

Lookup NU author(s): Dr Morag Andrew, Professor Jeremy Parr

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2025 Hopewell et al. Aims: Muscle strengthening exercises are one of the interventions frequently prescribed by physiotherapists for adolescents with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The ROBUST trial will assess the clinical effectiveness of an individually tailored strengthening programme, including progressive resistance exercises and advice, compared to usual care for ambulant adolescents with spastic CP. Methods: We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit adolescents aged 12 to 18 years with a diagnosis of spastic CP (bilateral or unilateral) Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with the assessment procedures and exercise programme with or without support. Participants will be recruited from at least 12 UK NHS Trust physiotherapy and related services. Participants (n = 334) will be randomized (centralized computer-generated 1:1 allocation ratio) to either: 1) a progressive resistance exercise programme, with six one-to-one physiotherapy sessions over 16 weeks; or 2) usual NHS care, with a single physiotherapy session and an assessment session, and advice regarding self-management and exercise. Conclusion The primary outcome is functional mobility measured using the child-/parent-reported Gait Outcomes Assessment List (GOAL) at six months. Secondary outcomes are: clinician-assessed muscle strength (Five Times Sit-to-Stand Test) and motor function (timed up and go test) at six months; functional mobility (GOAL) at 12 months; independence (GOAL subdomain A), balance (GOAL subdomain A, B, D), pain and discomfort (GOAL subdomain C), health-related quality of life (youth version of the EuroQol five-dimension questionnaire; EQ-5D-Y), educational attendance, exercise adherence, and additional physiotherapy treatment (six and 12 months). The primary analysis will be intention to treat.


Publication metadata

Author(s): Hopewell S, Keene DJ, Marian I, Perry DC, Rombach I, Andrew M, Barry C, Davis L, Firth G, Fletcher H, Fordham B, Gregory Osborne V, Gregory Osborne H, Katchburian L, O'Mahoney J, Parr J, Rapson R, Ryan J, Saeedi E, Stone M, Wood H, Theologis T

Publication type: Article

Publication status: Published

Journal: Bone and Joint Open

Year: 2025

Volume: 6

Issue: 5

Pages: 517-527

Print publication date: 01/05/2025

Online publication date: 01/05/2025

Acceptance date: 02/04/2018

Date deposited: 28/05/2025

ISSN (electronic): 2633-1462

Publisher: British Editorial Society of Bone and Joint Surgery

URL: https://doi.org/10.1302/2633-1462.65.BJO-2024-0268

DOI: 10.1302/2633-1462.65.BJO-2024-0268

Data Access Statement: The data that support the findings for this study are available to other researchers from the corresponding author upon reasonable request.


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Funding

Funder referenceFunder name
National Institute for Health and Care Research (NIHR), Health Technology Assessment Programme (NIHR 135150)

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