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The effect of botulinum toxin-A on the functional ability of the very young child with spastic hemiplegia due to cerebral palsy.

A randomised controlled trial to determine the effects of botulinum toxin-A on the functional ability of the very young child with spastic hemiplegia due to cerebral palsy.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000484448
Enrollment
30
Registered
2007-09-21
Start date
2002-10-01
Completion date
Unknown
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

Cerebral palsy (CP) is a disorder affecting around 2.5 in 1000 live births. Commonly, children with CP have spasticity in their muscles causing stiffness. Children with spasticity move differently because of this stiffness. When botulinum toxin-A (BOTOX) is injected into a spastic muscle, it helps relax the muscle for around three months, after which the effect begins to wear off. During this time, the muscle is able to move more freely through a greater range, allowing the child to use more normal patterns of muscle recruitment. BOTOX is recommended and PBS rebatable for children with CP who are over two years of age and who are ambulant. Usually, by two years of age these children have developed an abnormal pattern of movement, especially around the ankle. Currently, the most important clinical question is whether BOTOX should be used to prevent this early imperfect standing and walking practice rather than be used after two years of age to correct the problem that has developed. Injections of BOTOX at a younger age may provide the child with an early sensation of more normal movement and lay down patterns of movement that will be useful in the long term. The aim of this study is to compare, over a three year period, the effects of early (beginning at the motor stage of "pull-to-stand") repeated BOTOX injections on gross motor function and the development of walking with the effects of later ( beginning after two years of age) standard repeated BOTOX treatment. The main measures will be the gross motor function measures and quality of walking. Measurements (such as muscle spasticity, muscle length, parent questionnaires and functional ability of the upper limb) will also be made to determine which program most positively affects walking, other gross motor functions and /or quality of life.

Interventions

botulinum toxin-A (BOTOX) to treat spastic equinus by intramuscular injection; 6-12 U/kgtotal body weight; repeat injections at no less than six monthly intervals beginning at the motor stage of "pull to stand"

Sponsors

Sarah Love
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
9 Months to 22 Months
Healthy volunteers
No

Inclusion criteria

spastic hemiplegia due to CP

Exclusion criteria

already independently ambulating; concurrent unrelated disability or serious long term illness

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026