RecruitingPhase 4ACTRN12609000360213

Evaluation of the effects of botulinum toxin A injections in improving ease of care and increasing comfort in children with marked cerebral palsy: a randomised controlled trial.

The effects of botulinum toxin A injections on ease of care and comfort in children with marked cerebral palsy

Sponsor

Qld Cerebral Palsy Health Service

Enrollment

30 participants

Start Date

Mar 16, 2009

Study Type

Interventional

Conditions

Marked cerebral palsy:Gross Motor Function Classification System (GMFCS) 4-5

Summary

Children with the more severe forms of cerebral palsy often have difficulties with pain or discomfort associated with spasticity. Spasticity can also impact upon the burden of care parents experience. Botulinum toxin A has been used for over a decade in the treatment of spasticity for children with cerebral palsy however most research to date has focussed on functional gains for children with the less severe forms of cerebral palsy. this study hypothesises that botulinum toxin A injections when combined with a therapy program improves outcomes of burden of care and comfort for children with severe cerebral palsy when compared to a therapy program alone.

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for children with severe cerebral palsy who experience pain or discomfort because of muscle stiffness (spasticity) and whose families have high levels of care demands. It is testing whether injections of botulinum toxin A (commonly known as Botox) combined with a therapy programme reduces pain and makes caring for the child easier, compared to therapy alone. You may be eligible if: - Your child is between 2 and 16 years old - Your child has a diagnosis of cerebral palsy classified as GMFCS level 4 or 5 (more severe forms) - The main goals for your child involve improving comfort and making care easier You may NOT be eligible if: - There is a medical reason your child cannot receive botulinum toxin A - Your child has received botulinum toxin A injections within the past 6 months - Your child has had arm or leg casting within the past 2 months - Your child's spasticity medications have been changed in the past 2 months Talk to your doctor about whether this trial might be right for you.

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 injections to clinically selected muscles, occupational therapy, physiotherapy. Dose: Total dose not to exceed 12 units per kg or 400 units total. Dosage per muscle group: Upper l

Botulinum toxin A injections to clinically selected muscles, occupational therapy, physiotherapy. Dose: Total dose not to exceed 12 units per kg or 400 units total. Dosage per muscle group: Upper limb Intrinsic muscles hand: 1/2 unit per kg or maximum 20 units per muscle. Finger flexors: 1/2 - 1 unit per kg or maximum 30 units. Wrist flexors:1/2 - 1 unit per kg or maximum 30 units. Pronators: 1/2 - 1 unit per kg or maximum 30 units. Elbow flexors: 1-2 units per kg or maximum 60 units. Pectoral muscles, lattisimus dorsi, teres major: 1/2 - 2 units per kg or maximum 60 units per muscle group. Deltoid: 1 unit per kg or maximum 50 units. Lower limb Adductors: 2-4 units per kg maximum dose 80 units. Hamstrings: 2-4 units per kg with maximum dose 80 units. Quadriceps:2-4 units per kg maximum dose 80 units. Gastrocnemius: 2-4 units per kg maximum dose 100 units. Maximum dose 50 units per site. Any injection > 50 units requires more than one injection site. All injections are intramuscular with ultrasound and/or nerve stimulator guidance. Injections (or placebo) occur at baseline. Injections are repeated at 6 months. children will all receive physical therapy and occupational therapy following injections/ sham procedure for up to 6 weeks on a weekly basis. Therapy will include serial casting for maximum 2 weeks as required. Occupational therapy and or physiotherapy requirements are determined on patient goals by blinded therapist. Injections will be repeated at a 6 month interval. Analgesia for injections will be provided with intranasal fentanyl and topical anaesthetic.

Locations(1)

Australia

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ACTRN12609000360213