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Trial registered on ANZCTR


Registration number
ACTRN12614001276640
Ethics application status
Approved
Date submitted
25/11/2014
Date registered
5/12/2014
Date last updated
18/07/2019
Date data sharing statement initially provided
18/07/2019
Date results information initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
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?
Secondary ID [1] 285654 0
none
Universal Trial Number (UTN)
U1111-1164-0572
Trial acronym
Minimising impairment trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with cerebral palsy 293572 0
Condition category
Condition code
Neurological 293857 293857 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 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.
Intervention code [1] 290653 0
Rehabilitation
Comparator / control treatment
The control group will not receive a rigid 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-informed occupational therapy, the use of equipment or BoNT-A injections.
Control group
Active

Outcomes
Primary outcome [1] 293636 0
Passive range of passive wrist extension (measured with the fingers extended) measured using a goniometer
Timepoint [1] 293636 0
3 Years
Primary outcome [2] 293637 0
Active range of wrist movement measured using standardised goniometric measurement and use of clinometer for measures of supination and inertial motion sensors
Timepoint [2] 293637 0
3 Years
Secondary outcome [1] 311502 0
Body function outcomes:
Muscle tone (finger flexors, wrist extensors, pronators and elbow flexors) measured using Modified Ashworth Scale (Boyd et al, 1999);
Timepoint [1] 311502 0
3 Years
Secondary outcome [2] 311503 0
Body function outcomes:
Muscle spasticity (finger flexors, wrist extensors, pronators and elbow flexors), measured using Modified Tardieu Scale;
Timepoint [2] 311503 0
3 Years
Secondary outcome [3] 311504 0
Body function outcomes:
Grip Strength measured using hand held dynamometer Merlini et al. 2002);
Timepoint [3] 311504 0
3 Years
Secondary outcome [4] 311505 0
Body function outcomes:
Hand deformity measured using the Neurological Hand Deformity Classification (Wilton 2004);
Timepoint [4] 311505 0
3 Years
Secondary outcome [5] 311673 0
Body function measures:
Pain measured using a study specific questionnaire
Timepoint [5] 311673 0
3 years
Secondary outcome [6] 311674 0
Activity level outcomes:
Self care skills measured using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT; Haley, et al. 2011);
Timepoint [6] 311674 0
3 years
Secondary outcome [7] 311675 0
Activity level outcomes:
Manual Ability measured using ABILHAND-Kids (Arnould, et al. 2004);
Timepoint [7] 311675 0
3 years
Secondary outcome [8] 311676 0
Activity level outcomes:
Speed and dexterity measured using Box and Blocks Test (Mathiowetz et al. 1985);
Timepoint [8] 311676 0
3 years
Secondary outcome [9] 311677 0
Activity level outcomes:
Hand function measured using the Modified House Scale (Geerdink et al. 2014);
Timepoint [9] 311677 0
3 years
Secondary outcome [10] 311678 0
Activity level outcomes:
Ease of care measured using a study specific questionnaire.
Timepoint [10] 311678 0
3 years
Secondary outcome [11] 311679 0
Participation outcomes:
measured using the Participation and Environment Measure for Children and Youth (PEM-CY; Coster et al. 2011)
Timepoint [11] 311679 0
3 years
Secondary outcome [12] 311680 0
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)
Timepoint [12] 311680 0
3 years
Secondary outcome [13] 311681 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 [13] 311681 0
3 years

Eligibility
Key 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.
Minimum age
5 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

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 /Participant Information Statements) 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 studies. 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 severity of passive wrist range.
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
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. However, in the absence of clear evidence in the literature the variability has been estimated to approximate 22degrees. A sample size of 77 in each group is estimated to be sufficient to detect a 10degrees between-group difference with 80% power and a two-tailed level of significance of .05. A total of 194 participants is therefore required to allow for a 20% drop-out.
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 the difference from baseline 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 severity of wrist range of movement used in the randomisation. The regression model will be fitted using generalised estimating equations (GEE) to allow for the clustering of observations within participants for those who have both limbs in the study.
To explore the effect of 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 GEEs 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 (Wilton Hand Deformity Classification) and treatment by the inclusion of interaction terms in the linear regression model (Again this model will be fitted using GEEs). Finally the effect of potential confounders will be examined using an adjusted GEE model.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 3165 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 3166 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [3] 3167 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 6467 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 8954 0
3052 - Parkville
Recruitment postcode(s) [2] 8955 0
6008 - Subiaco
Recruitment postcode(s) [3] 8956 0
3168 - Clayton
Recruitment postcode(s) [4] 8957 0
2100 - Allambie
Recruitment postcode(s) [5] 14021 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 290278 0
University
Name [1] 290278 0
Australian Catholic University
Address [1] 290278 0
PO Box 968 North Sydney NSW 2059
Country [1] 290278 0
Australia
Funding source category [2] 290279 0
Government body
Name [2] 290279 0
National Health and Medical Research Centre, Australia
Address [2] 290279 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 290279 0
Australia
Primary sponsor type
Individual
Name
Christine Imms
Address
Australian Catholic University
Level 2, Daniel Mannix Building,
17 Young Street, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 288988 0
Individual
Name [1] 288988 0
Margaret Wallen
Address [1] 288988 0
The Cerebral Palsy Alliance
187 Allambie Rd,
Allambie Heights, NSW 2100, Australia
Country [1] 288988 0
Australia
Secondary sponsor category [2] 288989 0
Individual
Name [2] 288989 0
Catherine Elliott
Address [2] 288989 0
Department of Paediatric Rehabilitation
Princess Margaret Hospital for Children
Roberts Road,
Subiaco WA 6008
Country [2] 288989 0
Australia
Secondary sponsor category [3] 288990 0
Individual
Name [3] 288990 0
Brian Hoare
Address [3] 288990 0
Monash Medical Centre
246 Clayton Rd,
Clayton VIC 3168
Country [3] 288990 0
Australia
Secondary sponsor category [4] 288991 0
Individual
Name [4] 288991 0
Susan Greaves
Address [4] 288991 0
The Royal Children's Hospital
Flemington Road,
Parkville, 3052 Victoria,
Country [4] 288991 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291976 0
Monash Medical Centre
Ethics committee address [1] 291976 0
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [1] 291976 0
Australia
Date submitted for ethics approval [1] 291976 0
Approval date [1] 291976 0
09/10/2014
Ethics approval number [1] 291976 0
14199B
Ethics committee name [2] 291977 0
Perth Children's Hospital
Ethics committee address [2] 291977 0
Perth Children's Hospital
15 Hospital Avenue, Nedlands
Western Australia 6009
Ethics committee country [2] 291977 0
Australia
Date submitted for ethics approval [2] 291977 0
02/06/2014
Approval date [2] 291977 0
25/11/2014
Ethics approval number [2] 291977 0
2014060
Ethics committee name [3] 291978 0
The Cerebral Palsy Alliance
Ethics committee address [3] 291978 0
187 Allambie Road Allambie Heights New South Wales Australia 2100
Ethics committee country [3] 291978 0
Australia
Date submitted for ethics approval [3] 291978 0
18/07/2014
Approval date [3] 291978 0
04/09/2014
Ethics approval number [3] 291978 0
2014-08-02
Ethics committee name [4] 291979 0
Australian Catholic University
Ethics committee address [4] 291979 0
PO Box 968 North Sydney NSW 2059
Ethics committee country [4] 291979 0
Australia
Date submitted for ethics approval [4] 291979 0
11/11/2014
Approval date [4] 291979 0
24/11/2014
Ethics approval number [4] 291979 0
2014 317V
Ethics committee name [5] 291980 0
The Royal Children's Hospital Melbourne
Ethics committee address [5] 291980 0
Fleminton Road
Parkville, 3052 VIC
Ethics committee country [5] 291980 0
Australia
Date submitted for ethics approval [5] 291980 0
25/11/2014
Approval date [5] 291980 0
08/05/2015
Ethics approval number [5] 291980 0
RCH HREC- 34280A

Summary
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.
Trial website
http://www.cre-cp.org.au/research/current-research-projects/upper-limb-orthoses/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52650 0
Prof Christine Imms
Address 52650 0
Australian Catholic University
Level 2, Daniel Mannix Building,
17 Young Street,
Fitzroy VIC 3065
Country 52650 0
Australia
Phone 52650 0
61+399533404
Fax 52650 0
Email 52650 0
christine.imms@acu.edu.au
Contact person for public queries
Name 52651 0
Prof Christine Imms
Address 52651 0
Australian Catholic University
Level 2, Daniel Mannix Building,
17 Young Street,
Fitzroy VIC 3065
Country 52651 0
Australia
Phone 52651 0
+61399533404
Fax 52651 0
Email 52651 0
Christine.imms@acu.edu.au
Contact person for scientific queries
Name 52652 0
Prof Christine Imms
Address 52652 0
Australian Catholic University
Level 2, Daniel Mannix Building,
17 Young Street,
Fitzroy VIC 3065
Country 52652 0
Australia
Phone 52652 0
+61 3 99533404
Fax 52652 0
Email 52652 0
christine.imms@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in original consent.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 3111 0
Study protocol
Citation [1] 3111 0
Imms, C., Wallen, M., Elliott, C., Hoare, B., Randall, M., Greaves, S., Adair, B., Bradshaw, E., Orsini, F., Carter, R., Shih, S.T.F., & Reddihough, D. (2016). Minimising impairment: Protocol for a multicenter randomized controlled trial of upper limb orthoses for children with cerebral palsy. BMC Pediatrics, 16:70.
Email [1] 3111 0
Other [1] 3111 0
Attachment [1] 3111 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary