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A randomized controlled trial comparing botulinum toxin A dosage in the upper extremity of children with spasticity
Anne Kawamura1, Kent Campbell, Sophie Lam-Damji
1Department of Paediatrics, Bloorview Research Institute, Bloorview Kids Rehab, University of Toronto, Toronto, ON, Canada.
Insights
Low and high doses of botulinum toxin A (BTX-A) showed no significant difference in improving upper extremity function in children with spasticity over three months. This suggests dosage may not impact outcomes for this condition.
Area of Science:
- Pediatric Neurology
- Rehabilitation Medicine
- Pharmacology
Background:
- Spasticity in children, often due to cerebral palsy, significantly impacts upper extremity function.
- Botulinum toxin A (BTX-A) is a common treatment for focal spasticity.
- Optimal BTX-A dosing for pediatric upper extremity spasticity remains an area of investigation.
Purpose of the Study:
- To compare the efficacy of low-dose versus high-dose BTX-A in improving upper extremity function in children with spastic hemiplegia or triplegia.
- To evaluate the impact of different BTX-A doses on motor function and self-care abilities.
Main Methods:
- A double-blind, randomized controlled trial involving 39 children with spastic hemiplegia or triplegia.
- Participants received either a low dose or a high dose of BTX-A targeting specific upper extremity muscles.
- Outcomes, including upper extremity function (Quality of Upper Extremity Skills Test) and self-care (Pediatric Evaluation of Disability Inventory), were assessed at baseline, 1 month, and 3 months post-injection.
Main Results:
- No statistically significant difference was found between the low-dose and high-dose BTX-A groups in upper extremity function at 1 and 3 months post-injection.
- Similarly, no significant differences were observed in the self-care domain of the Pediatric Evaluation of Disability Inventory between the groups.
- While grip strength decreased in both groups over the study period, the difference between low and high doses was not significant.
Conclusions:
- The study indicates that low and high doses of BTX-A yield comparable outcomes for upper extremity function in children with spasticity at 1 and 3 months.
- These findings suggest that a lower dose of BTX-A may be sufficient for managing upper extremity spasticity in this pediatric population, potentially reducing treatment costs and side effects.
- The results provide valuable guidance for clinicians in determining appropriate BTX-A dosages for pediatric patients.
Abstract:
This study compared the effects of low and high doses of botulinum toxin A (BTX-A) to improve upper extremity function. Thirty-nine children (22 males, 17 females) with a mean age of 6 years 2 months (SD 2y 9mo) diagnosed with spastic hemiplegia or triplegia were enrolled into this double-blind, randomized controlled trial. The high-dose group received BTX-A in the following doses: biceps 2U/kg, brachioradialis 1.5U/kg, common flexor origin 3U/kg, pronator teres 1.5U/kg, and adductor/opponens pollicis 0.6U/kg to a maximum of 20U. The low-dose group received 50% of this dosage. Outcomes were measured at baseline and at 1 and 3 months after injection, and results were analyzed with a repeated-measures analysis of variance. There was no significant difference between the low-dose and high-dose groups in upper extremity function over the 3-month period as measured by the Quality of Upper Extremity Skills Test (F[1,37]=0.18, p=0.68). There was no difference between the groups in the Pediatric Evaluation of Disability Inventory Self Care Domain (F[1,37]=0.05, p=0.83). Although grip strength decreased over the 3-month period, there was no difference between groups (F[1,32]=0.45, p=0.51). These findings indicate that there is no difference in hand and arm function between a low dose and a high dose of BTX-A at 1 and 3 months after injection. This information can be used to guide dosage of BTX-A for the management of upper extremity spasticity in children.
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