ActivePhase 3ACTRN12607000484448

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.


Sponsor

Sarah Love

Enrollment

30 participants

Start Date

Oct 1, 2002

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 9 MonthssMax Age: 22 Monthss

Plain Language Summary

Simplified for easier understanding

This study looks at the effect of botulinum toxin-A on the functional ability of the very young child with spastic hemiplegia due to cerebral palsy. It is open to both men and women aged 9 Months to 22 Months. Participants will be screened based on specific health criteria to see if they qualify. If you join, the research team will explain what is involved and monitor your health throughout the study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 "pul

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"


Locations(1)

Australia

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ACTRN12607000484448