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Botulinum toxin A for nonambulatory children with cerebral palsy: a double blind randomized controlled trial
Lisa Copeland1, Priya Edwards1, Megan Thorley1
1Queensland Cerebral Palsy Health Service, Department of Rehabilitation, Royal Children's Hospital, Brisbane, Australia; Queensland Cerebral Palsy and Rehabilitation Research Center, School of Medicine, The University of Queensland, Brisbane, Australia.
Insights
Intramuscular botulinum toxin A (BoNT-A) injections improved comfort and ease of care for nonambulant children with cerebral palsy (CP). The treatment showed sustained benefits at 16 weeks with no increase in moderate to severe adverse events.
Area of Science:
- Pediatric Neurology
- Rehabilitation Medicine
- Movement Disorders
Background:
- Cerebral palsy (CP) is a common neurodevelopmental disorder affecting motor function.
- Nonambulant children with CP often experience significant spasticity, impacting comfort and care.
- Improving ease of care and comfort is a critical goal in managing CP.
Purpose of the Study:
- To evaluate the efficacy of intramuscular botulinum toxin A (BoNT-A) in reducing spasticity.
- To assess the impact of BoNT-A on comfort and ease of care in nonambulant children with CP.
- To determine the safety profile of BoNT-A in this population.
Main Methods:
- A double-blind, randomized, sham-controlled trial was conducted.
- Participants included 41 nonambulant children with CP (GMFCS levels IV-V).
- Children received either intramuscular BoNT-A injections or a sham procedure, combined with therapy, with outcomes assessed using the Canadian Occupational Performance Measure (COPM) at 4 and 16 weeks.
Main Results:
- BoNT-A treatment significantly improved COPM performance and satisfaction at 4 weeks compared to sham (P < .05).
- Improvements in COPM satisfaction were retained at 16 weeks (P = .04).
- Mild adverse events were more frequent in the BoNT-A group, but no significant differences in moderate or severe adverse events were observed.
Conclusions:
- Intramuscular BoNT-A, combined with therapy, is effective in enhancing ease of care and comfort for nonambulant children with CP.
- The treatment demonstrates sustained benefits for patient satisfaction.
- BoNT-A is a safe therapeutic option for this patient group, with no increased risk of moderate to severe adverse events.
Objectives:
To examine the efficacy and safety of intramuscular botulinum toxin A (BoNT-A) to reduce spasticity and improve comfort and ease of care in nonambulant children with cerebral palsy (CP).
Study Design:
Nonambulant children with CP (n = 41; Gross Motor Function Classification System level IV = 3, level V = 38; mean age 7.1 years, range 2.3-16 years, 66% male) were randomly allocated to receive either intramuscular BoNT-A injections (n = 23) or sham procedure (n = 18) combined with therapy. The analysis used generalized estimating equations with primary outcome the Canadian Occupational Performance Measure (COPM) at 4 weeks postintervention and retention of effects at 16 weeks. Adverse events (AE) were collected at 2, 4, and 16 weeks by a physician masked to group allocation.
Results:
There were significant between group differences favoring the BoNT-A-treated group on COPM performance at 4 weeks (estimated mean difference 2.2, 95% CI 0.8, 3.5; P = .002) and for COPM satisfaction (estimated mean difference 2.2, 95% CI 0.5, 3.9; P = .01). These effects were retained at 16 weeks for COPM satisfaction (estimated mean difference 1.8, 95% CI 0.1, 3.5; P = .04). There were more mild AE at 4 weeks for the BoNT-A group (P = .002), however, there were no significant between-group differences in the reporting of moderate and serious AE.
Conclusions:
In a double-blind randomized sham-controlled trial, intramuscular BoNT-A and therapy were effective for improving ease of care and comfort for nonambulant children with CP. There was no increase in moderate and severe AE in the children who had BoNT-A injections compared with the sham group.
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