Minimising impairment: protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy
Data(s) |
01/01/2016
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Resumo |
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. <br /><br />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. <br /><br />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.<br /> |
Identificador | |
Idioma(s) |
eng |
Publicador |
BioMed Central |
Relação |
http://dro.deakin.edu.au/eserv/DU:30084123/carter-minimisingimpairment-2016.pdf http://www.dx.doi.org/10.1186/s12887-016-0608-8 |
Direitos |
2016, The Authors |
Palavras-Chave | #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 |
Tipo |
Journal Article |