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Trial registered on ANZCTR


Registration number
ACTRN12607000446460
Ethics application status
Approved
Date submitted
31/08/2007
Date registered
31/08/2007
Date last updated
23/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Modified constraint-induced therapy for children with cerebral palsy: A randomised controlled trial
Scientific title
A single-blind randomised controlled trial of the effectiveness of modified constraint-induced therapy compared with standard best-practice occupational therapy on family focussed functional outcomes in children with hemiplegic cerebral palsy.
Secondary ID [1] 287966 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiplegic cerebral palsy 2313 0
Condition category
Condition code
Neurological 2415 2415 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 2416 2416 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified constraint-induced therapy. Children with hemiplegic cerebral palsy wear a mitt on their unaffected hand for 2 hours per day for 8 weeks. Targetted motor therapy is completed during the time the mitt is on the hand.
Intervention code [1] 2035 0
Rehabilitation
Comparator / control treatment
Children participate in 8 weeks of standard best practice occupational therapy involving weekly visits to an occupational therapist and a home programme.
Control group
Active

Outcomes
Primary outcome [1] 3313 0
Canadian Occupational Performance Measure
Timepoint [1] 3313 0
Baseline, 8 weeks (completion of intervention), 6 months
Secondary outcome [1] 5520 0
Goal Attainment Scaling
Timepoint [1] 5520 0
8 weeks, 6 months
Secondary outcome [2] 5521 0
Assisting Hand Assessment (bimanual ability)
Timepoint [2] 5521 0
Baseline, 8 weeks, 6 months
Secondary outcome [3] 5522 0
Pediatric Motor Activity Log
Timepoint [3] 5522 0
Baseline, 8 weeks, 6 months
Secondary outcome [4] 5523 0
Modified Tardieu Scale for elbow flexors, pronator, wrist flexors
Timepoint [4] 5523 0
Baseline, 8 weeks, 6 months
Secondary outcome [5] 5524 0
Modified Ashworth Scale for elbow flexors, pronator, wrist flexors
Timepoint [5] 5524 0
Baseline, 8 weeks, 6 months
Secondary outcome [6] 5525 0
Parent questionnaire of perception of change, views on participation in intervention
Timepoint [6] 5525 0
Baseline, 8 weeks, 6 months

Eligibility
Key inclusion criteria
Children aged between 6 months and 8 years; with spastic hemiplegic cerebral palsy, as diagnosed by a neurodevelopmental paediatrician; some active wrist extension and/or finger extension in the affected upper limb; passive range of movement (ROM) in the affected upper limb that allows functional activity; the ability to cooperate for assessment and therapy sessions; parents indicate a strong commitment to attending all assessments, providing daily therapy to the child, and to attending weekly therapy appointments; and access to weekly occupational therapy.
Minimum age
18 Months
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with altered upper limb management in the 4 months preceding baseline assessment, including casting, surgery, botulinum toxin injections or altered splinting regimes

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)
Following consent, a baseline assessment will be completed at which time a study number will be allocated. Then a researcher will contact an independent person, otherwise not associated with the study, to determine the child's allocation according to the allocated study number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be according to a computer-generated schedule of randomly permuted blocks (mixed sizes) provided by the NHMRC Clinical Trials Centre.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2007
Actual
3/01/2008
Date of last participant enrolment
Anticipated
Actual
9/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 2579 0
Charities/Societies/Foundations
Name [1] 2579 0
The Cerebral Palsy Institute
Country [1] 2579 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Locked Bag 4001
WESTMEAD NSW 2145
Country
Australia
Secondary sponsor category [1] 2329 0
University
Name [1] 2329 0
Assoc Prof Jenny Ziviani
Address [1] 2329 0
School of Health and Rehabilitation Studies
The University of Queensland QLD 4072
Country [1] 2329 0
Australia
Secondary sponsor category [2] 2330 0
Charities/Societies/Foundations
Name [2] 2330 0
Olivia Naylor
Address [2] 2330 0
The Centre for Cerebral Palsy
PO Box 61
MT LAWLEY WA 6929
Country [2] 2330 0
Australia
Other collaborator category [1] 23 0
University
Name [1] 23 0
Assoc Prof Rob Herbert
Address [1] 23 0
School of Physiotherapy
The University of Sydney
PO Box 170
LIDCOMBE NSW 1825
Country [1] 23 0
Australia
Other collaborator category [2] 29 0
Charities/Societies/Foundations
Name [2] 29 0
Iona Novak
Address [2] 29 0
The Spastic Centre of NSW
PO Box 184 BROOKVALE NSW 2100
Country [2] 29 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4496 0
The Children's Hospital at Westmead Ethics Committee
Ethics committee address [1] 4496 0
Locked Bag 4001
WESTMEAD NSW 2145
Ethics committee country [1] 4496 0
Australia
Date submitted for ethics approval [1] 4496 0
Approval date [1] 4496 0
29/09/2005
Ethics approval number [1] 4496 0
2005/074
Ethics committee name [2] 4497 0
Medical Research Ethics Comittee, The University of Queensland
Ethics committee address [2] 4497 0
The Office of Research and Post-Graduate Studies
The University of Queensland QLD 4072
Ethics committee country [2] 4497 0
Australia
Date submitted for ethics approval [2] 4497 0
Approval date [2] 4497 0
02/05/2007
Ethics approval number [2] 4497 0
2006000939
Ethics committee name [3] 4498 0
Research and Ethics Comittee
Ethics committee address [3] 4498 0
The Spastic Centre of NSW
PO Box 184
BROOKVALE NSW 2100
Ethics committee country [3] 4498 0
Australia
Date submitted for ethics approval [3] 4498 0
Approval date [3] 4498 0
08/01/2006
Ethics approval number [3] 4498 0
2006-10-04
Ethics committee name [4] 4499 0
Research and Development Group
Ethics committee address [4] 4499 0
The Centre for Cerebral Palsy
PO Box 61
MT LAWLEY WA 6929
Ethics committee country [4] 4499 0
Australia
Date submitted for ethics approval [4] 4499 0
Approval date [4] 4499 0
13/04/2007
Ethics approval number [4] 4499 0
Not provided by organisation

Summary
Brief summary
BACKGROUND: Upper limb dysfunction is one of the most important predictors of participation restriction in children with cerebral palsy. Modified constraint-induced therapy is an intervention designed to improve the function of the affected arm of children with hemiplegic cerebral palsy and maximise their participation in daily activities. This therapy involves constraining the unaffected hand with a mitt and providing concurrent and carefully targeted therapy during the period of constraint. It has been argued that the constraint of the unaffected side encourages the child to use the affected side, providing opportunity for the child to develop muscle control and strength and to reduce learned non-use. Modified constraint-induced therapy is already offered in Australian clinics even though it is an expensive and intensive intervention and there is little evidence of its effectiveness. This randomised controlled trial will evaluate the effects of modified constraint-induced therapy on children’s upper limb function and participation in daily activities. If the intervention is to be widely adopted it must first be shown to be substantially more effective than current best practices in paediatric service provision. HYPOTHESES: Children with spastic hemiplegic cerebral palsy participating in modified constraint-induced therapy will have better upper limb function and will be better able to complete important daily activities than a group receiving standard best practice occupational therapy. STUDY: Randomised controlled trial. Fifty children with spastic hemiplegic cerebral palsy, aged between 18 months and 8 years and meeting specified eligibility criteria will be recruited from The Children’s Hospital at Westmead, The Centre for Cerebral Palsy and The Spastic Centre of NSW. Consenting families will complete a baseline assessment and then be randomised to a modified constraint-induced therapy group or standard best practice occupational therapy group. Therapy (and constraint) will start 1 week later and continue for 8 weeks. Children will be reassessed at 8 weeks and 6 months. Intervention for the experimental group will consist of modified constraint-induced therapy. Constraint will be implemented by a custom-made mitt which prevents grasp and release with the unaffected hand. The mitt will be worn for a minimum of 2 hours per day, 7 days per week for 8 weeks. In addition, adjunct therapy (to improve motor ability of the affected upper limb) will be provided daily by carers whilst the constraint is in place and once per week by an occupational therapist. The adjunct therapy is a critical component of modified constraint-induced therapy. The control group will participate in standard best practice occupational therapy for 8 weeks. The provision of standard practice controls for frequency of provision of occupational therapy. More importantly, it allows us to establish if modified constraint-induced therapy is more effective than current best practice, which should be a pre-requisite for implementation of this therapy.
Trial website
Trial related presentations / publications
Modified constraint-induced therapy for children with hemiplegic cerebral palsy: A randomised trial. Developmental Medicine and Child Neurology, 2011, 53, 1091–1099. Wallen, M, Ziviani, J., Herbert, R, Evans, R, Naylor, O, & Novak,I.
Public notes

Contacts
Principal investigator
Name 28020 0
Dr Margaret Wallen
Address 28020 0
Research Institute
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest NSW 2086
Country 28020 0
Australia
Phone 28020 0
+61 2 9975 8808
Fax 28020 0
Email 28020 0
[email protected]
Contact person for public queries
Name 11177 0
Margaret Wallen
Address 11177 0
Research Institute
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest NSW 2086
Country 11177 0
Australia
Phone 11177 0
+61 2 9975 8808
Fax 11177 0
Email 11177 0
[email protected]
Contact person for scientific queries
Name 2105 0
Margaret Wallen
Address 2105 0
Research Institute
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest NSW 2086
Country 2105 0
Australia
Phone 2105 0
+61 2 9975 8808
Fax 2105 0
Email 2105 0
[email protected]

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Results publications and other study-related documents

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