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

• Register: ANZCTR
• Last refreshed on: 3 October 2022
• Main ID: ACTRN12614001275651
• Date of registration: 05/12/2014
• Prospective Registration: Yes
• Primary sponsor: Christine Imms
• Public title: iWHOTrial (infant Wrist Hand Orthoses Trial): A multicentre randomized controlled trial of rigid wrist hand orthoses for young children with cerebral palsy.
• Scientific title: Does wearing a rigid wrist hand orthosis in combination with evidence informed occupational therapy, compared to evidence informed occupational therapy alone, prevent and/or reduce wrist/hand impairment and improve activity and participation outcomes in children aged less than 3 years with, or at risk of, cerebral palsy?
• Date of first enrolment: 14/09/2015
• Target sample size: 94
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12614001275651.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Christine Imms

• Name: Ms Georgie Rose

Key inclusion & exclusion criteria

Inclusion criteria: Diagnosis of, or identified as at risk of, cerebral palsy as reported in the child’s medical history. Every 6 months the diagnosis/risk of CP will be reviewed and at study exit a diagnosis of cerebral palsy needs to be confirmed by a medical specialist.
Aged 0-35 months on recruitment;
Presents with persistent abnormal flexion postures of the wrist +/- fingers +/- thumb;
Full passive range of movement in the wrist and hand;
Parents able to understand written and spoken English.
Exclusion criteria: The presence of child and/or family factors, determined in consultation with the family, that identify upper limb orthoses wear as not clinically indicated;
Allergy/sensitivity to splinting material;
Family inability to access the study assessment or treatment site (due to geography).


Age minimum: Months
Age maximum: 35 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Cerebral palsy or at risk of cerebral palsy;
Cerebral palsy or at risk of cerebral palsy

Intervention(s)

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.

Primary Outcome(s)

Passive range of movement at the wrist (wrist extension) measured using standardised goniometric measurement. [Three years]

Secondary Outcome(s)

Body Function outcomes:
Muscle stiffness (finger flexors, wrist extensors, pronators and elbow flexors), measured using Modified Ashworth and Modified Tardieu Scale (R1) (Boyd et al, 1999);
[Three years]

Body Function outcomes:
Hand deformity measured using the Neurological Hand Deformity Classification (Wilton, 2004);
[Three years]

Quality of Life measured using Cerebral Palsy Quality of Life Questionnaire -(CPQoL-Child) and the Assessment of Quality of Life tool the AQoL-8D - multi-attribute utility instrument. [3 years ]

Activity performance measured using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT; Haley, et al. 2011); and Study specific questionnaire.[Three years]

Body function measure
Pain measured using a study specific questionnaire[Three years]

Relative cost and cost effectiveness measured using pathway analysis to document treatment activity, specify unit prices and estimate costs and potential cost offsets across the arms of the trial. Costs will be assessed by expenditure category (salaries; capital; overheads; consumables; etc.) as well as incidence (i.e. who bears the cost).[3 years]

Participation measured using the Young Children's Participation and Environment questionnaire (Khetani et al. 2012) [3 years]

Secondary ID(s)

none

Source(s) of Monetary Support

Australian Catholic University

National Health and Medical Research Centre, Australia

Percy and Ruby Hady Foundation

Secondary Sponsor(s)

Susan Greaves

Brian Hoare

Catherine Elliott

Margaret Wallen

Ethics review

Status: Approved
Approval date: 04/09/2014
Contact:

Status: Approved
Approval date: 09/10/2014
Contact:

Status: Approved
Approval date: 24/11/2014
Contact:

Status: Approved
Approval date: 25/11/2014
Contact:

Status: Approved
Approval date: 23/04/2015
Contact:

Status: Approved
Approval date: 10/01/2019
Contact:

Status: Approved
Approval date: 21/02/2019
Contact:

Results

• Date Posted: 28/09/2022