Abstract
The objective of this clinical trial was to compare the efficacy and safety of letibotulinum toxin A and onabotulinum toxin A for improving dynamic equinus foot deformity in children with cerebral palsy (CP). In total, 144 children with spastic CP who had dynamic equinus foot deformity were assigned randomly to the Botulax group (injection of letibotulinum toxin A) or the Botox group (injection of onabotulinum toxin A). The Physician’s Rating Scale (PRS), ankle plantar flexor spasticity using the Modified Tardieu Scale, the Gross Motor Function Measure (GMFM)-88, and the GMFM-66 were completed before injection and at 6, 12, and 24 weeks after injection. The PRS responder rate was 60.27% in the Botulax group and 61.43% in the Botox group at 12 weeks after treatment, and the lower limit of the 95% confidence interval for the between-group difference in responder rates was −17.16%, higher than the non-inferiority margin of −24.00%. The clinical efficacy and the safety profiles of the groups did not significantly differ. The results suggest that injection of letibotulinum toxin A is as effective and safe as that of onabotulinum toxin A for the treatment of dynamic equinus foot deformity in children with spastic CP.
Highlights
Cerebral palsy (CP), which is characterized by movement and posture disorders caused by non-progressive lesions in the developing brain, is the most common developmental disorder associated with lifelong motor impairment and disability [1,2]
144 subjects participated in the study, with 73 subjects randomly assigned to the Botulax group and 71 assigned to the Botox group (Figure 1)
There was no statistically significant difference between the two groups in the serious adverse events incidence (Table 4). This randomized, double-blind, controlled trial showed that botulinum toxin type-A (BoNT-A) injection at the gastrocnemius muscle improved dynamic equinus foot deformity in children with spastic cerebral palsy (CP) and that the effectiveness and safety of letibotulinum toxin A were not inferior to those of onabotulinum toxin A
Summary
Cerebral palsy (CP), which is characterized by movement and posture disorders caused by non-progressive lesions in the developing brain, is the most common developmental disorder associated with lifelong motor impairment and disability [1,2]. Spasticity is a major impairment in children with CP, affecting approximately two-thirds of this population [3]. Equinus is a common gait abnormality in children with CP, resulting from spasticity of the ankle plantar flexor [4]. Since the first reports in the early 1990s, botulinum toxin type-A (BoNT-A) has been used for the management of spasticity in the lower limbs of children with CP [5,6]. BoNT-A injections decrease spasticity locally by interfering with cholinergic transmission at the neuromuscular junction [7]. BoNT-A has been established as an effective treatment for the management of spastic equinus, as it improves gait, goal attainment, and function [8]
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