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Minimising impairment: 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, Greaves, Susan, Adair, Brooke, Bradshaw, Elizabeth, Carter, Rob, Orsini, Francesca, Shih, Sophy T. F. and Reddihough, Dinah 2016, Minimising impairment: protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy, BMC Pediatrics, vol. 16, Article number : 70, pp. 1-15, doi: 10.1186/s12887-016-0608-8.

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Title Minimising impairment: protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy
Formatted title Minimising impairment: protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy
Author(s) Imms, Christine
Wallen, Margaret
Elliott, Catherine
Hoare, Brian
Randall, Melinda
Greaves, Susan
Adair, Brooke
Bradshaw, Elizabeth
Carter, RobORCID iD for Carter, Rob orcid.org/0000-0002-1586-5619
Orsini, Francesca
Shih, Sophy T. F.
Reddihough, Dinah
Journal name BMC Pediatrics
Volume number 16
Season Article number : 70
Start page 1
End page 15
Total pages 15
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2016
ISSN 1471-2431
Keyword(s) cerebral palsy
children
cost-effectiveness
intervention
occupational therapy
orthosis
randomised trial
splint
upper extremity
Science & Technology
Life Sciences & Biomedicine
Pediatrics
OF-LIFE QUESTIONNAIRE
BOTULINUM-TOXIN-A
GONIOMETRIC MEASUREMENTS
PSYCHOMETRIC PROPERTIES
CLASSIFICATION-SYSTEM
MANUAL ABILITY
GROSS MOTOR
RELIABILITY
POPULATION
SPASTICITY
Summary 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.
Language eng
DOI 10.1186/s12887-016-0608-8
Field of Research 140208 Health Economics
111703 Care for Disabled
1114 Paediatrics And Reproductive Medicine
Socio Economic Objective 920403 Disability and Functional Capacity
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30084123

Document type: Journal Article
Collections: Faculty of Health
Population Health
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.