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 3Â 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 3Â 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. |