Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001275651
Ethics application status
Approved
Date submitted
25/11/2014
Date registered
5/12/2014
Date last updated
28/09/2022
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
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?
Secondary ID [1] 285655 0
none
Universal Trial Number (UTN)
U1111-1164-0647
Trial acronym
iWHOTrial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy or at risk of cerebral palsy 293557 0
Condition category
Condition code
Neurological 293844 293844 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290642 0
Rehabilitation
Comparator / control treatment
Children in the control group will not receive a wrist hand orthosis.
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-based occupational therapy, home programs, the use of equipment or BoNT-A injections.
Control group
Active

Outcomes
Primary outcome [1] 293623 0
Passive range of movement at the wrist (wrist extension) measured using standardised goniometric measurement.
Timepoint [1] 293623 0
Three years
Secondary outcome [1] 311483 0
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);
Timepoint [1] 311483 0
Three years
Secondary outcome [2] 311484 0
Body Function outcomes:
Hand deformity measured using the Neurological Hand Deformity Classification (Wilton, 2004);
Timepoint [2] 311484 0
Three years
Secondary outcome [3] 311485 0
Body function measure
Pain measured using a study specific questionnaire
Timepoint [3] 311485 0
Three years
Secondary outcome [4] 311486 0
Activity performance measured using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT; Haley, et al. 2011); and Study specific questionnaire.
Timepoint [4] 311486 0
Three years
Secondary outcome [5] 311670 0
Participation measured using the Young Children's Participation and Environment questionnaire (Khetani et al. 2012)
Timepoint [5] 311670 0
3 years
Secondary outcome [6] 311671 0
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.
Timepoint [6] 311671 0
3 years
Secondary outcome [7] 311672 0
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).
Timepoint [7] 311672 0
3 years

Eligibility
Key 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.
Minimum age
0 Months
Maximum age
35 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The treating clinical teams at each trial site will identify potential participants and provide written information about the study (Recruitment letter/ study advertisement/Parent/Guardian Information Statement) and briefly discuss the study with the family. Families will also be advised of the study by site-specific newsletters, websites and social media with an invitation to contact study personnel or treating therapists for more information about the study. Through discussion and clinical examination of the upper limb/s, eligibility will be determined and informed consent sought from the parent(s)/guardian of the child.

Once consent has been obtained, and following baseline assessment, children will be randomised to either the treatment or comparison group with an allocation ratio of 1:1. The randomisation schedule and web-based service will be provided by the Clinical Epidemiology and Biostatistics Unit (CEBU) at the Murdoch Childrens Research Institute and concealed from the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a web-based procedure and will be in randomly permuted blocks of variable length, stratified by study centre, and by topographical distribution of the motor impairment, that is, either unilateral or bilateral involvement.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Update
Sample size calculations were performed according to the primary dependent variable; passive range of movement of wrist extension (measured with fingers extended) at 3 years. Data obtained from prior splinting studies were used to provide some evidence of variability in the primary outcome. Sample size calculations were based on data provided by Rameckers et al (2009) who reported baseline standard deviation (SD) of 12.4degrees in a group with hemiplegic cerebral palsy. Based on a SD of 12degrees for the primary outcome, 37 participants per group would be required to detect an 8degrees between-group difference in passive range of movement with 80% power and a two-tailed level of significance of 0.05. A total of 94 participants is therefore required to allow for 10% loss to follow-up and 10% withdrawal.
Statistical analysis will follow standard methods for randomised trials and the primary analysis will be by intention to treat (ITT), including all randomised participants where outcome data are available. Comparison between the intervention and the control groups in passive range of wrist extension will be presented as the mean difference at 36 months and its 95% confidence interval (CI), obtained using a linear regression model adjusted for the stratification factors of site, and topographical distribution of the motor impairment used in the randomisation. The regression model will be fitted using linear mixed models to allow for the clustering of observations within participants for those who have both limbs in the study.
To explore the effect of the adherence to WHO wearing schedule (i.e. a dose response relationship), a linear regression model will be fitted with compliance to treatment as a predictor and difference in the passive range of wrist extension from baseline to 36 months as the outcome, applied to all study participants. Again, this model will be fitted using linear mixed models to allow for the clustering of limbs within participants. Finally, we will explore evidence for an interaction between age and treatment as well as for an interaction between severity (Neurological Hand Deformity Classification) and treatment by the inclusion of interaction terms in the linear regression model (again, using linear mixed models). Finally, the effect of potential confounders will be examined using adjusted linear mixed models.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/01/2015
Actual
14/09/2015
Date of last participant enrolment
Anticipated
31/12/2021
Actual
1/02/2022
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
94
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 3155 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 3157 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 6309 0
Perth Children's Hospital - Nedlands
Recruitment hospital [4] 6466 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [5] 14240 0
Novita - Regency Park
Recruitment hospital [6] 14241 0
Choice Passion Life - Brisbane City
Recruitment postcode(s) [1] 8936 0
3052 - Parkville
Recruitment postcode(s) [2] 8938 0
3168 - Clayton
Recruitment postcode(s) [3] 8939 0
2100 - Allambie Heights
Recruitment postcode(s) [4] 13846 0
6009 - Nedlands
Recruitment postcode(s) [5] 14020 0
6008 - Subiaco
Recruitment postcode(s) [6] 27233 0
5010 - Regency Park
Recruitment postcode(s) [7] 27234 0
4000 - Brisbane City

Funding & Sponsors
Funding source category [1] 290271 0
University
Name [1] 290271 0
Australian Catholic University
Country [1] 290271 0
Australia
Funding source category [2] 290272 0
Government body
Name [2] 290272 0
National Health and Medical Research Centre, Australia
Country [2] 290272 0
Australia
Funding source category [3] 303318 0
Charities/Societies/Foundations
Name [3] 303318 0
Percy and Ruby Hady Foundation
Country [3] 303318 0
Australia
Primary sponsor type
Individual
Name
Christine Imms
Address
University of Melbourne, Murdoch Children's Research Institute
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 288978 0
Individual
Name [1] 288978 0
Margaret Wallen
Address [1] 288978 0
Australian Catholic University
Level 3 | Tenison Woods House
8-20 Napier St | North Sydney | NSW | 2060
PO Box 968 | North Sydney | NSW | 2059
Country [1] 288978 0
Australia
Secondary sponsor category [2] 288979 0
Individual
Name [2] 288979 0
Catherine Elliott
Address [2] 288979 0
Department of Paediatric Rehabilitation
Perth Children's Hospital
Roberts Road, Subiaco WA 6008
Country [2] 288979 0
Australia
Secondary sponsor category [3] 288980 0
Individual
Name [3] 288980 0
Brian Hoare
Address [3] 288980 0
Monash Medical Centre
246 Clayton Rd,
Clayton VIC 3168
Country [3] 288980 0
Australia
Secondary sponsor category [4] 288981 0
Individual
Name [4] 288981 0
Susan Greaves
Address [4] 288981 0
The Royal Children's Hospital
Flemington Road,
Parkville, 3052 Victoria,
Country [4] 288981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291967 0
Monash Medical Centre
Ethics committee address [1] 291967 0
Ethics committee country [1] 291967 0
Australia
Date submitted for ethics approval [1] 291967 0
Approval date [1] 291967 0
09/10/2014
Ethics approval number [1] 291967 0
14201B
Ethics committee name [2] 291968 0
Perth Children's Hospital - Child and Adolescent Health Service HREC
Ethics committee address [2] 291968 0
Ethics committee country [2] 291968 0
Australia
Date submitted for ethics approval [2] 291968 0
02/06/2014
Approval date [2] 291968 0
25/11/2014
Ethics approval number [2] 291968 0
2014061
Ethics committee name [3] 291969 0
The Cerebral Palsy Alliance
Ethics committee address [3] 291969 0
Ethics committee country [3] 291969 0
Australia
Date submitted for ethics approval [3] 291969 0
Approval date [3] 291969 0
04/09/2014
Ethics approval number [3] 291969 0
2014-08-02
Ethics committee name [4] 291970 0
Australian Catholic University
Ethics committee address [4] 291970 0
Ethics committee country [4] 291970 0
Australia
Date submitted for ethics approval [4] 291970 0
Approval date [4] 291970 0
24/11/2014
Ethics approval number [4] 291970 0
2014 318V
Ethics committee name [5] 291971 0
The Royal Children's Hospital Melbourne
Ethics committee address [5] 291971 0
Ethics committee country [5] 291971 0
Australia
Date submitted for ethics approval [5] 291971 0
25/11/2014
Approval date [5] 291971 0
23/04/2015
Ethics approval number [5] 291971 0
RCH HREC reference 34279A
Ethics committee name [6] 303852 0
South Australia Health Human Research Ethics Committee - Site Specific Governance
Ethics committee address [6] 303852 0
Ethics committee country [6] 303852 0
Australia
Date submitted for ethics approval [6] 303852 0
21/12/2018
Approval date [6] 303852 0
21/02/2019
Ethics approval number [6] 303852 0
HREC Reference: 18-1-E
Ethics committee name [7] 303853 0
CPL Human Research Ethics Committee
Ethics committee address [7] 303853 0
Ethics committee country [7] 303853 0
Australia
Date submitted for ethics approval [7] 303853 0
02/11/2018
Approval date [7] 303853 0
10/01/2019
Ethics approval number [7] 303853 0
HREC Reference: CPL-2018-004

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52746 0
Prof Christine Imms
Address 52746 0
University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 52746 0
Australia
Phone 52746 0
+61393454953
Fax 52746 0
Email 52746 0
[email protected]
Contact person for public queries
Name 52747 0
Georgie Rose
Address 52747 0
Murdoch Children's Research Institute
The Royal Children's Hospital, 50 Flemington Road
Parkville, Victoria 3052 Australia
Country 52747 0
Australia
Phone 52747 0
+61 3 9345 4953
Fax 52747 0
Email 52747 0
[email protected]
Contact person for scientific queries
Name 52748 0
Christine Imms
Address 52748 0
University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 52748 0
Australia
Phone 52748 0
+61 3 93454953
Fax 52748 0
Email 52748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To be confirmed with Investigator team.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.