title: Minimising impairment: Protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ANZ Clinical Trials Registry: U1111-1164-0572 .
authors.affiliation: Centre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia. Christine.imms@acu.edu.au.
authors.forename: Christine
authors.initials: C
authors.lastname: Imms
authors.affiliation: Cerebral Palsy Alliance, PO Box 6427, Frenchs Forest, NSW, 2086, Australia.
authors.forename: Margaret
authors.initials: M
authors.lastname: Wallen
authors.affiliation: School of Occupational Therapy and Social Work, Curtin University, Bentley, Australia.
authors.forename: Catherine
authors.initials: C
authors.lastname: Elliott
authors.affiliation: Monash Children's Hospital, Clayton, Australia.
authors.forename: Brian
authors.initials: B
authors.lastname: Hoare
authors.affiliation: Centre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia.
authors.forename: Melinda
authors.initials: M
authors.lastname: Randall
authors.affiliation: Royal Children's Hospital, Flemington Rd, Parkville, 3052, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Greaves
authors.affiliation: Centre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia.
authors.forename: Brooke
authors.initials: B
authors.lastname: Adair
authors.affiliation: Centre for Disability and Development Research, Faculty of Health Sciences, Australian Catholic University, 17 Young Street, Fitzroy, VIC, 3065, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Bradshaw
authors.affiliation: Deakin University, Building BC, Room BC3.113, 221 Burwood Highway, Burwood, Australia.
authors.forename: Rob
authors.initials: R
authors.lastname: Carter
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Australia.
authors.forename: Francesca
authors.initials: F
authors.lastname: Orsini
authors.affiliation: Deakin University, Building BC, Room BC3.113, 221 Burwood Highway, Burwood, Australia.
authors.forename: Sophy T F
authors.initials: ST
authors.lastname: Shih
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Australia.
authors.forename: Dinah
authors.initials: D
authors.lastname: Reddihough
mesh_terms: D000293:Adolescent; D002547:Cerebral Palsy / Q000503:physiopathology / Q000534:rehabilitation*; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006225:Hand; D018737:Hand Strength / Q000502:physiology; D006801:Humans; D008297:Male; D009788:Occupational Therapy / Q000379:methods; D009989:Orthotic Devices; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D016059:Range of Motion, Articular; D016037:Single-Blind Method; D016896:Treatment Outcome; D014953:Wrist; D014955:Wrist Joint / Q000503:physiopathology
keywords: Cerebral palsy; Children; Cost-effectiveness; Intervention; Occupational therapy; Orthosis; Randomised trial; Splint; Upper extremity