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Clinical effectiveness of a child-specific dynamic stretching programme, compared to usual care, for ambulant children with spastic cerebral palsy (SPELL 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, British Editorial Society of Bone and Joint Surgery. All rights reserved. Aims: Dynamic muscle stretching exercises are one of the interventions frequently prescribed by physiotherapists for children with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The SPELL trial will assess the clinical effectiveness of an individually tailored dynamic stretching programme, compared to usual care for ambulant children with spastic CP. Methods: We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit children aged four to 11 years with a diagnosis of spastic CP (bilateral or unilateral) and Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with 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 one:one allocation ratio) to either: 1) a dynamic stretching 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, 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: joint range of motion (Cerebral Palsy Integrated Pathway protocol) 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 at six and 12 months. The primary analysis will be intention to treat.


Publication metadata

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

Publication type: Article

Publication status: Published

Journal: Bone and Joint Open

Year: 2025

Volume: 6

Issue: 5

Pages: 506-516

Print 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-2024-0267

DOI: 10.1302/2633-1462.65.BJO-2024-0267

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 (NIHR135131)

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