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Modified constraint-induced therapy for children with cerebral palsy: A randomised controlled trial

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000446460
Enrollment
50
Registered
2007-08-31
Start date
2008-01-03
Completion date
2009-10-09
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

The Children's Hospital at Westmead
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Months to 8 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026