scholarly journals IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study

2021 ◽  
pp. 1-15
Author(s):  
Florian Heinen ◽  
Petr Kaňovský ◽  
A. Sebastian Schroeder ◽  
Henry G. Chambers ◽  
Edward Dabrowski ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Motor Function ◽  
Lower Limb ◽  
Double Blind Study ◽  
Phase 3 ◽  
Gross Motor ◽  
Gross Motor Function ◽  
Limb Spasticity ◽  
Lower Limb Spasticity ◽  
Clinical Patterns

PURPOSE: Investigate the efficacy and safety of multipattern incobotulinumtoxinA injections in children/adolescents with lower-limb cerebral palsy (CP)-related spasticity. METHODS: Phase 3 double-blind study in children/adolescents (Gross Motor Function Classification System – Expanded and Revised I–V) with unilateral or bilateral spastic CP and Ashworth Scale (AS) plantar flexor (PF) scores ⩾ 2 randomized (1:1:2) to incobotulinumtoxinA (4, 12, 16 U/kg, maximum 100, 300, 400 U, respectively) for two 12- to 36-week injection cycles. Two clinical patterns were treated. Pes equinus (bilateral or unilateral) was mandatory; if unilateral, treatment included flexed knee or adducted thigh. Endpoints: Primary: AS-PF change from baseline to 4 weeks; Coprimary: investigator-rated Global Impression of Change Scale (GICS)-PF at 4 weeks; Secondary: investigator’s, patient’s, and parent’s/caregiver’s GICS, Gross Motor Function Measure-66 (GMFM-66). RESULTS: Among 311 patients, AS-PF and AS scores in all treated clinical patterns improved from baseline to 4-weeks post-injection and cumulatively across injection cycles. GICS-PF and GICS scores confirmed global spasticity improvements. GMFM-66 scores indicated better motor function. No significant differences between doses were evident. Treatment was well-tolerated, with no unexpected treatment-related adverse events or neutralising antibody development. CONCLUSION: Children/adolescents with lower-limb spasticity experienced multipattern benefits from incobotulinumtoxinA, which was safe and well-tolerated in doses up to 16 U/kg, maximum 400 U.

scholarly journals The Effect of Botulinum Toxin Injections on Gross Motor Function for Lower Limb Spasticity in Children with Cerebral Palsy

Toxins ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 651 ◽  
Author(s):  
Ja Young Choi ◽  
Seung Ki Kim ◽  
Eun Sook Park
Keyword(s):  
Cerebral Palsy ◽  
Botulinum Toxin ◽  
Motor Function ◽  
Lower Limb ◽  
Gross Motor ◽  
Gross Motor Function ◽  
Younger Age ◽  
Injection Type ◽  
Limb Spasticity ◽  
Lower Limb Spasticity

The aim of this study was to investigate the use of botulinum toxin type A (BoNT-A) injections and their efficacy on gross motor function for lower limb spasticity in children with spastic cerebral palsy (CP). This retrospective study included 919 injection occasions from 591 children with CP who received a lower limb BoNT-A injection between 2006 and 2016. The Gross Motor Function Measure (GMFM-88), the Modified Ashworth Scale, and the Modified Tardieu Scale were administered before and after injections. Injections were predominantly administered to children under the age of 6 years. The most common muscle injection site was the calf muscle for dynamic foot deformity. The second most commonly injected muscle was the hip adductor among 2–3 year olds and the hamstring muscle among 4–6 year olds. Distal injections were predominantly administered to high-functioning children, whereas proximal injections were typically administered to low-functioning children. Multilevel injections were mostly administered to midfunctioning children. GMFM-88 scores significantly increased post-injection for both high- and low-functioning groups. Younger age at injection and distal injection type were associated with larger improvements on the GMFM-88 at both short- and midterm follow-up. The target muscles for injection varied depending on gross motor functioning and age. Younger age at injection and distal injection type were significantly related with greater gain in gross motor function.

Efficacy and safety of incobotulinumtoxinA for upper- or combined upper- and lower-limb spasticity in children and adolescents with cerebral palsy: Results of the Phase 3 XARA study

Toxicon ◽  
2021 ◽  
Vol 190 ◽  
pp. S14-S15
Author(s):  
Edward Dabrowski ◽  
Henry G. Chambers ◽  
Deborah Gaebler-Spira ◽  
Marta Banach ◽  
Petr Kaňovský ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Children And Adolescents ◽  
Lower Limb ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Limb Spasticity ◽  
Lower Limb Spasticity

Safety of incobotulinumtoxinA in multipattern treatment of upper- and lower-limb spasticity in children/adolescents with cerebral palsy: Pooled analysis of 3 large phase 3 studies

Toxicon ◽  
2021 ◽  
Vol 190 ◽  
pp. S7
Author(s):  
Marta Banach ◽  
Petr Kaňovský ◽  
A. Sebastian Schroeder ◽  
Henry G. Chambers ◽  
Edward Dabrowski ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Lower Limb ◽  
Pooled Analysis ◽  
Phase 3 ◽  
Large Phase ◽  
Limb Spasticity ◽  
Lower Limb Spasticity

scholarly journals Gait synergetic neuromuscular control in children with cerebral palsy at different gross motor function classification system levels

2019 ◽  
Vol 121 (5) ◽  
pp. 1680-1691 ◽  
Author(s):  
Yi Yu ◽  
Xiang Chen ◽  
Shuai Cao ◽  
De Wu ◽  
Xu Zhang ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Motor Function ◽  
Lower Limb ◽  
Classification System ◽  
Neuromuscular Control ◽  
Muscle Synergies ◽  
Gross Motor ◽  
Gross Motor Function ◽  
Gait Abnormalities ◽  
Semg Signals

Cerebral palsy (CP) is a neural developmental disease featured with gait abnormalities. CP gait assessment is usually performed with the Gross Motor Function Classification System (GMFCS) in clinics, which does not involve a thorough assessment of neuromuscular control. To understand how the neuromuscular control disorders lead to gait abnormalities, we explored the relationship between GMFCS levels and the gait synergetic control characteristics in this study. In total, 18 children with CP at different GMFCS levels (mean age: 4.41±1.30 yr) and 8 age-matched typically developing (TD) children (mean age: 4.43±1.36 yr) were recruited to perform a straight walking task, and the surface electromyographic (sEMG) signals from eight lower limb muscles on each side and accelerometer data were collected. A nonnegative matrix factorization method was applied to obtain the muscle synergies from the sEMG signals. Next, synergy structures were projected onto the basic gait synergies to test the completeness of those structures. Subsequently, synergy activation parameters, including total activation duration and coactivation index, were compared across the participants. This study showed that children with CP at GMFCS levels I and II and the TD children had similar synergy structures, but the synergy activations of these children with CP were different from those of TD children. In addition, similar to previous research, we also found that children with CP at GMFCS level III could not access all four basic synergies on both sides. Based on the synergy analysis results, a gait assessment paradigm was proposed to facilitate the clinical CP gait evaluation. NEW & NOTEWORTHY Understanding the mechanism of gait abnormality has important clinical significance for the diagnosis, prognosis, and possible treatment of motor dysfunction in children with cerebral palsy (CP). In this study, the comparisons of the lower limb muscle synergies among different groups of children with CP at different Gross Motor Function Classification System levels might provide some new insight into the mechanism underlying the gait disorder. In particular, the discrepancies of gait synergy structure and activation patterns across the study groups may indicate different neurophysiological and pathological attributes in different groups of patients.

scholarly journals The Influence of Cryotherapy on the Lower Limb Spasticity for Children with Cerebral Palsy

2018 ◽  
Vol 2 (85) ◽  
Author(s):  
Saulė Sipavičenė ◽  
Antanas Damašauskas ◽  
Irina Klizienė ◽  
Gražina Krutulytė ◽  
Aiva Karpavičienė ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Lower Limb ◽  
Control Group ◽  
Gross Motor ◽  
Motor Functions ◽  
Physical Exercises ◽  
Children With Cerebral Palsy ◽  
Limb Spasticity ◽  
Lower Limb Spasticity

Research background and hypothesis. Cryotherapy could reduce spasticity for children with cerebral palsy.Research aim. The aim of this study was to determine the effect of cryotherapy on the lower limb spasticity for children with cerebral palsy.Research methods. Fourteen children with cerebral palsy spastic Diplegia aged 6–12 years were examined. The procedures of cryotherapy and physical therapy were applied to children in the test group (n = 7), and only physical therapy – for the members in the control group (n = 7). For all the subjects, the following procedures were performed before and after the research: foot extension measurements, the determination of the spasticity of flexors and selective foot motion, the estimation of balance and gross motor functions. Research  results.  After  physical  exercises  foot  extension  showed  improvement,  spasticity  of  foot  flexors reduced, foot selective movements, balance and gross motor functions improved. There was no statistical difference between the results in both groups.Discussion and conclusions. The influence of cryotherapy on the lower limb spasticity for children with cerebral palsy was not statistically significant.Keywords: spasticity, cryotherapy, physical exercises.

Prevalence of Speech Problems and the Use of Augmentative and Alternative Communication in Children With Cerebral Palsy: A Registry-Based Study in Norway

2010 ◽  
Vol 19 (1) ◽  
pp. 12-20 ◽  
Author(s):  
Guro Andersen ◽  
Tone R. Mjøen ◽  
Torstein Vik
Keyword(s):  
Cerebral Palsy ◽  
Motor Function ◽  
Gestational Age ◽  
Augmentative And Alternative Communication ◽  
Alternative Communication ◽  
Gross Motor ◽  
Gross Motor Function ◽  
Children With Cerebral Palsy ◽  
Communicative Abilities ◽  
Normal Speech

Abstract This study describes the prevalence of speech problems and the use of augmentative and alternative communication (AAC) in children with cerebral palsy (CP) in Norway. Information on the communicative abilities of 564 children with CP born 1996–2003, recorded in the Norwegian CP Registry, was collected. A total of 270 children (48%) had normal speech, 90 (16%) had slightly indistinct speech, 52 (9%) had indistinct speech, 35 (6%) had very indistinct speech, 110 children (19%) had no speech, and 7 (1%) were unknown. Speech problems were most common in children with dyskinetic CP (92 %), in children with the most severe gross motor function impairments and among children being totally dependent on assistance in feeding or tube-fed children. A higher proportion of children born at term had speech problems when compared with children born before 32 weeks of gestational age 32 (p > 0.001). Among the 197 children with speech problems only, 106 (54%) used AAC in some form. Approximately 20% of children had no verbal speech, whereas ~15% had significant speech problems. Among children with either significant speech problems or no speech, only 54% used AAC in any form.

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