Minimising impariment: Protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy
Imms, Christine, Wallen, Margaret, Elliott, Catherine, Hoare, Brian, Randall, Melinda Joy, Greaves, Susan, Adair, Brooke, Bradshaw, Elizabeth, Carter, Rob, Orsini, Francesca, Shih, Sophy T. F. and Reddihough, Dinah S.. (2016). Minimising impariment: Protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy. BMC Pediatrics. 16(70), pp. 1 - 15. https://doi.org/10.1186/s12887-016-0608-8
|Authors||Imms, Christine, Wallen, Margaret, Elliott, Catherine, Hoare, Brian, Randall, Melinda Joy, Greaves, Susan, Adair, Brooke, Bradshaw, Elizabeth, Carter, Rob, Orsini, Francesca, Shih, Sophy T. F. and Reddihough, Dinah S.|
Background: Upper limb orthoses are frequently prescribed for children with cerebral palsy ( CP ) who have muscle overactivity predominantly due to spasticity, with little evidence of long-term effectiveness. Clinical consensus is that orthoses help to preserve range of movement: nevertheless, they can be complex to construct, expensive, uncomfortable and require commitment from parents and children to wear. This protocol paper describes a randomised controlled trial to evaluate whether long-term use of rigid wrist/hand orthoses ( WHO ) in children with CP, combined with usual multidisciplinary care, can prevent or reduce musculoskeletal impairments, including muscle stiffness/tone and loss of movement range, compared to usual multidisciplinary care alone. Methods/design: This pragmatic, multicentre, assessor-blinded randomised controlled trial with economic analysis will recruit 194 children with CP, aged 5–15 years, who present with flexor muscle stiffness of the wrist and/or fingers/thumb ( Modified Ashworth Scale score ≥1 ). Children, recruited from treatment centres in Victoria, New South Wales and Western Australia, will be randomised to groups ( 1:1 allocation ) using concealed procedures. All children will receive care typically provided by their treating organisation. The treatment group will receive a custom-made serially adjustable rigid WHO, prescribed for 6 h nightly ( or daily ) to wear for 3 years. An application developed for mobile devices will monitor WHO wearing time and adverse events. The control group will not receive a WHO, and will cease wearing one if previously prescribed. Outcomes will be measured 6 monthly over a period of 3 years. The primary outcome is passive range of wrist extension, measured with fingers extended using a goniometer at 3 years. Secondary outcomes include muscle stiffness, spasticity, pain, grip strength and hand deformity. Activity, participation, quality of life, cost and cost-effectiveness will also be assessed. Discussion: This study will provide evidence to inform clinicians, services, funding agencies and parents/carers of children with CP whether the provision of a rigid WHO to reduce upper limb impairment, in combination with usual multidisciplinary care, is worth the effort and costs. Trial registration: ANZ Clinical Trials Registry: U1111-1164-0572.
|Keywords||upper extremity; splint; orthosis; children; cerebral palsy; occupational therapy; intervention; randomised trial; cost-effectiveness|
|Journal citation||16 (70), pp. 1 - 15|
|Publisher||Biomed Central Ltd|
|Digital Object Identifier (DOI)||https://doi.org/10.1186/s12887-016-0608-8|
|Open access||Open access|
|Page range||1 - 15|
|Research Group||School of Allied Health|
© 2016 Imms et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
|Place of publication||United Kingdom|
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