iWHOTrial (infant Wrist Hand Orthoses Trial): A multicentre randomized controlled trial of rigid wrist hand orthoses for young children with cerebral palsy.

The treatment group will receive a custom-made serially adjustable rigid volar wrist-hand orthosis (WHO) 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. Children will be asked to wear the orthosis overnight, or for a minimum of 6 hours during the night or day, (nightly/daily) for the 3 years of the study, to achieve a prolonged positioning effect with the orthosis. Although night time wear is recommended, for some children it may be appropriate to wear the orthosis during the day. All children (regardless of group allocation) will receive care typically provided by their usual treating organisation. Possible treatments may include evidence-informed therapy such as developmentally appropriate, goal focused and evidence-informed occupational therapy, the use of equipment or BoNT-A injections. Data on the frequency and duration that each child wears the orthosis will be recorded on a daily basis by the family in either electronic or paper format. Parents will be educated to report any adverse events to study staff. 6-monthly parent interviews will collect information on concomitant upper limb therapies received.