Minimising impairment: Protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy

BMC Pediatrics

Study Protocol

Elizabeth Bradshaw¹  Christine Imms¹  Brooke Adair¹  Melinda Randall¹  Margaret Wallen²  Sophy T. F. Shih³  Rob Carter³  Brian Hoare⁴  Dinah Reddihough⁵  Francesca Orsini⁵  Susan Greaves⁶  Catherine Elliott⁷ 

[1] Centre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, 3065, Fitzroy, VIC, Australia;Cerebral Palsy Alliance, PO Box 6427, 2086, Frenchs Forest, NSW, Australia;Deakin University, Building BC, Room BC3.113, 221 Burwood Highway, Burwood, Australia;Monash Children’s Hospital, Clayton, Australia;Murdoch Childrens Research Institute, Parkville, Australia;Royal Children’s Hospital, Flemington Rd, 3052, Parkville, Australia;School of Occupational Therapy and Social Work, Curtin University, Bentley, Australia;

关键词: Upper extremity;    Splint;    Orthosis;    Children;    Cerebral palsy;    Occupational therapy;    Intervention;    Randomised trial;    Cost-effectiveness;   

DOI  :  10.1186/s12887-016-0608-8

 received in 2015-10-14, accepted in 2016-05-14,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundUpper 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/designThis 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.DiscussionThis 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 registrationANZ Clinical Trials Registry: U1111-1164-0572.

【 授权许可】

CC BY   
© Imms et al. 2016