Table 1.

Minimising impairment trial registration data: Protocol Version 3: 30.10.2014

Data Category	Information
Primary registry and trial identification number	ANZ Clinical Trials Register: U1111-1164-0572
Date of registration in primary registry	5.12.2014
Secondary identification numbers	N/A
Sources of money or material support	Australian Catholic University; National Health and Medical Research Council, Australia
Primary Sponsor	Investigator led: Professor Christine Imms
Contact for public queries	Dr Melinda Randall: Melinda.randall@acu.edu.au
Contact for scientific queries	Prof Christine Imms: Christine.imms@acu.edu.au
Public title	Minimising impairment: a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy.
Scientific title	Does wearing a rigid upper limb wrist hand orthosis in combination with evidence informed occupational therapy, compared to evidence informed occupational therapy alone, reduce wrist/hand impairment and improve activity and participation outcomes in children aged 5–15 years with cerebral palsy?
Countries of recruitment	Australia
Health condition studied	Cerebral palsy
Intervention	Intervention: custom-made serially adjustable rigid wrist hand orthoses to maintain the flexor compartment (muscles of the wrist, fingers and thumb) in a lengthened position to avoid shortening of the musculo-tendinous unit and other soft tissue.
	Control: The control group will not receive a rigid wrist/hand orthosis.
	Both groups: will receive care typically provided by their usual treating organisation. Possible treatments may include developmentally appropriate, goal focused and evidence-informed occupational therapy, the use of equipment or BoNT-A injections.
Key inclusion/exclusion criteria	Ages eligible for study: 5–15 years; Gender eligible: both;
	Inclusion criteria: A confirmed diagnosis of cerebral palsy as recorded in the medical history; Presence of flexor muscle stiffness - score at least 1 on the Modified Ashworth Scale during wrist extension with fingers extended; May or may not already exhibit contracture at the wrist.
	Exclusion criteria: upper limb dystonia without the presence of spasticity; an allergy or sensitivity to the materials used to construct orthoses; if families are unable to access the study site at the necessary times; and if families identify factors (e.g. child’s behaviour) that impact significantly on their ability to carry out the intervention
Study type	Interventional
	Allocation: randomised; intervention model: parallel assignment; Masking: Single blind.
	Primary purpose:
Date of first enrolment	28.8.2015
Target sample size	194
Recruitment status	Recruiting
Primary outcomes	Passive range of wrist extension (measured with the fingers extended) measured using a goniometer at 3 years; Active range of wrist movement measured using standardised goniometric measurement and use of clinometer for measures of supination and inertial motion sensors measures at 3 years;
Key secondary outcomes	Body function outcomes: Muscle tone; muscle spasticity; grip strength; hand deformity and pain.
	Activity outcomes: Self-care; Manual ability; Hand speed and dexterity; ease of care.
	Participation outcomes: Attendance and involvement in home, school and community activities.
	Quality of Life outcomes: Child and parent.
	Health economics outcomes: relative cost and cost-effectiveness.