ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hemiplegic cerebral palsy

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

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]

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]

Canadian Occupational Performance Measure

Timepoint [1]

Baseline, 8 weeks (completion of intervention), 6 months

Secondary outcome [1]

Goal Attainment Scaling

Timepoint [1]

8 weeks, 6 months

Secondary outcome [2]

Assisting Hand Assessment (bimanual ability)

Timepoint [2]

Baseline, 8 weeks, 6 months

Secondary outcome [3]

Pediatric Motor Activity Log

Timepoint [3]

Baseline, 8 weeks, 6 months

Secondary outcome [4]

Modified Tardieu Scale for elbow flexors, pronator, wrist flexors

Timepoint [4]

Baseline, 8 weeks, 6 months

Secondary outcome [5]

Modified Ashworth Scale for elbow flexors, pronator, wrist flexors

Timepoint [5]

Baseline, 8 weeks, 6 months

Secondary outcome [6]

Parent questionnaire of perception of change, views on participation in intervention

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Cerebral Palsy Institute

Address [1]

PO Box 184
BROOKVALE NSW 2100

Country [1]

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]

University

Name [1]

Assoc Prof Jenny Ziviani

Address [1]

School of Health and Rehabilitation Studies
The University of Queensland QLD 4072

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Olivia Naylor

Address [2]

The Centre for Cerebral Palsy
PO Box 61
MT LAWLEY WA 6929

Country [2]

Australia

Other collaborator category [1]

University

Name [1]

Assoc Prof Rob Herbert

Address [1]

School of Physiotherapy
The University of Sydney
PO Box 170
LIDCOMBE NSW 1825

Country [1]

Australia

Other collaborator category [2]

Charities/Societies/Foundations

Name [2]

Iona Novak

Address [2]

The Spastic Centre of NSW
PO Box 184 BROOKVALE NSW 2100

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Children's Hospital at Westmead Ethics Committee

Ethics committee address [1]

Locked Bag 4001
WESTMEAD NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/09/2005

Ethics approval number [1]

2005/074

Ethics committee name [2]

Medical Research Ethics Comittee, The University of Queensland

Ethics committee address [2]

The Office of Research and Post-Graduate Studies
The University of Queensland QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

02/05/2007

Ethics approval number [2]

2006000939

Ethics committee name [3]

Research and Ethics Comittee

Ethics committee address [3]

The Spastic  Centre of NSW
PO Box 184
BROOKVALE NSW 2100

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

08/01/2006

Ethics approval number [3]

2006-10-04

Ethics committee name [4]

Research and Development Group

Ethics committee address [4]

The Centre for Cerebral Palsy
PO Box 61
MT LAWLEY WA 6929

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

13/04/2007

Ethics approval number [4]

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

Dr Margaret Wallen

Address

Research Institute
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest NSW 2086

Country

Australia

Phone

+61 2 9975 8808

Fax

mwallen@cerebralpalsy.org.au

Contact person for public queries

Name

Margaret Wallen

Address

Research Institute
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest NSW 2086

Country

Australia

Phone

+61 2 9975 8808

Fax

mwallen@cerebralpalsy.org.au

Contact person for scientific queries

Name

Margaret Wallen

Address

Research Institute
Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest NSW 2086

Country

Australia

Phone

+61 2 9975 8808

Fax

mwallen@cerebralpalsy.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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