Dataset Information

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial.

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.

SUBMITTER: Chang HJ

PROVIDER: S-EPMC5577586 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial.

Chang Hyun Jung HJ Hong Bo Young BY Lee Sang-Jee SJ Lee Soyoung S Park Joo Hyun JH Kwon Jeong-Yi JY

Toxins 20170818 8

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 th ...[more]

PMID: 28820439

Similar Datasets

Project description:BackgroundComparisons between various conservative managements of spastic equinus deformity in cerebral palsy demonstrated limited evidences, to evaluate the efficacy of conservative treatment among cerebral palsy children with spastic equinus foot regarding gait and ankle motion.MethodsStudies were identified from PubMed and Scopus up to February 2022. Inclusion criteria were randomized controlled trial (RCT), conducted in spastic cerebral palsy children with equinus deformity, aged less than 18 years, compared any conservative treatments (Botulinum toxin A; BoNT-A, casting, physical therapy, and orthosis), and evaluated gait improvement (Physician Rating Scale or Video Gait Analysis), Observational Gait Scale, Clinical Gait Assessment Score, ankle dorsiflexion (ankle dorsiflexion at initial contact, and passive ankle dorsiflexion), or Gross Motor Function Measure. Any study with the participants who recently underwent surgery or received BoNT-A or insufficient data was excluded. Two authors were independently selected and extracted data. Risk of bias was assessed using a revised Cochrane risk-of-bias tool for randomized trials. I2 was performed to evaluate heterogeneity. Risk ratio (RR), the unstandardized mean difference (USMD), and the standardized mean difference were used to estimate treatment effects with 95% confidence interval (CI).ResultsFrom 20 included studies (716 children), 15 RCTs were eligible for meta-analysis (35% had low risk of bias). BoNT-A had higher number of gait improvements than placebo (RR 2.64, 95% CI 1.71, 4.07, I2 = 0). Its combination with physical therapy yielded better passive ankle dorsiflexion at knee extension than physical therapy alone (USMD = 4.16 degrees; 95% CI 1.54, 6.78, I2 = 36%). Casting with or without BoNT-A had no different gait improvement and ankle dorsiflexion at knee extension when compared to BoNT-A. Orthosis significantly increased ankle dorsiflexion at initial contact comparing to control (USMD 10.22 degrees, 95 CI% 5.13, 15.31, I2 = 87%).ConclusionBoNT-A and casting contribute to gait improvement and ankle dorsiflexion at knee extension. BoNT-A specifically provided gait improvement over the placebo and additive effect to physical therapy for passive ankle dorsiflexion. Orthosis would be useful for ankle dorsiflexion at initial contact. Trial registration PROSPERO number CRD42019146373.

Project description:AimTo assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP).MethodThis was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4.ResultsDuring cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively).InterpretationTreatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles.What this paper addsAbobotulinumtoxinA injections significantly reduced upper limb spasticity in children with cerebral palsy. Children treated with abobotulinumtoxinA and targeted home exercises showed global improvement and goal attainment. Benefits were sustained over 1 year with repeat cycles of abobotulinumtoxinA and home exercises. AbobotulinumtoxinA injections into the upper limb were well tolerated over 1 year.

Dataset Information

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial.

Publications

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets