Minimising impairment: A multicentre randomized controlled trial of upper limb orthoses for children with cerebral palsy.

• Register: ANZCTR
• Last refreshed on: 16 March 2021
• Main ID: ACTRN12614001276640
• Date of registration: 05/12/2014
• Prospective Registration: Yes
• Primary sponsor: Christine Imms
• Public title: Minimising impairment: A multicentre randomized 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?
• Date of first enrolment: 28/08/2015
• Target sample size: 194
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12614001276640.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: Prof Christine Imms

Key inclusion & exclusion criteria

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).


Age minimum: 5 Years
Age maximum: 15 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Children with cerebral palsy;
Children with cerebral palsy

Neurological - Other neurological disorders

Intervention(s)

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.

Primary Outcome(s)

Passive range of passive wrist extension (measured with the fingers extended) measured using a goniometer[3 Years]

Active range of wrist movement measured using standardised goniometric measurement and use of clinometer for measures of supination and inertial motion sensors [3 Years]

Secondary Outcome(s)

Quality of life outcomes measured using:
Quality of life: Cerebral Palsy Quality of Life Questionnaire - Child and Teen versions (Waters et al. 2007; Davis et al. 2013)
Assessing quality of life AQoL-8D - multi-attribute utility instrument (Richardson et al. 2014)[3 years ]

Body function outcomes:
Grip Strength measured using hand held dynamometer Merlini et al. 2002);[3 Years]

Body function outcomes:
Hand deformity measured using the Neurological Hand Deformity Classification (Wilton 2004);[3 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 ]

Body function outcomes:
Muscle spasticity (finger flexors, wrist extensors, pronators and elbow flexors), measured using Modified Tardieu Scale;[3 Years]

Body function measures:
Pain measured using a study specific questionnaire[3 years ]

Activity level outcomes:
Manual Ability measured using ABILHAND-Kids (Arnould, et al. 2004);
[3 years]

Activity level outcomes:
Self care skills measured using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT; Haley, et al. 2011);
[3 years]

Activity level outcomes:
Speed and dexterity measured using Box and Blocks Test (Mathiowetz et al. 1985);
[3 years]

Body function outcomes:
Muscle tone (finger flexors, wrist extensors, pronators and elbow flexors) measured using Modified Ashworth Scale (Boyd et al, 1999);[3 Years]

Participation outcomes:
measured using the Participation and Environment Measure for Children and Youth (PEM-CY; Coster et al. 2011)
[3 years ]

Activity level outcomes:
Ease of care measured using a study specific questionnaire.
[3 years ]

Activity level outcomes:
Hand function measured using the Modified House Scale (Geerdink et al. 2014);
[3 years]

Secondary ID(s)

none

Source(s) of Monetary Support

Australian Catholic University

National Health and Medical Research Centre, Australia

Secondary Sponsor(s)

Brian Hoare

Catherine Elliott

Margaret Wallen

Susan Greaves

Ethics review

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

The Cerebral Palsy Alliance

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

Monash Medical Centre

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

Australian Catholic University

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

Perth Children's Hospital

Status: Approved
Approval date: 08/05/2015
Contact:

The Royal Children's Hospital Melbourne

Results

• Results available: Yes
• Date Posted: 18/07/2019
• Date Completed: 20/12/2018