None listed
Conditions
Brief summary
We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for children with cerebral palsy. This trial aims to maintain and/or increase range of movement in the wrist thumb and fingers of children aged 5-15 years.
Interventions
The treatment group will receive a custom-made serially adjustable rigid 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 splint overnight, or for a minimum of 6 hours during the night or day (nightly/daily), for the three 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. An App (iPhone and android compatible) will be used to monitor factors such as the use of orthoses and any adverse events, based on parent report. Parents will receive a weekly text-reminder to record therapy received in the past week using simple response formats. Data recorded on the App will be supplemented through a 6-monthly parent interview conducted by the site based research assistant to record additional details about the usual evidence-informed therapy their child received in the preceding period. All children (regardless of group allocation) 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.
Sponsors
Study design
Eligibility
Inclusion criteria
A confirmed diagnosis of cerebral palsy as recorded in the medical history; Aged 5-15 years; 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
Dystonic, rather than spastic, motor disorder; Allergy/sensitivity to splinting material; Upper limb surgery during the study period or in the 12 months preceding study commencement; Significant child refusal to comply with splint wearing schedule; Family inability to access the study assessment or treatment site (due to geography).