Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double‐blind, placebo‐controlled, dose‐ranging study

Baker, Richard; Jasiński, Miłosz; Maciąg-Tymecka, Iwona; Michalowska-Mrozek, J; Bonikowski, Marcin; Carr, Lucinda; MacLean, Jill; Lin, J-P; Lynch, Bryan; Theologis, Tim; Wendorff, Janusz; Eunson, Paul; Cosgrove, Aidan

doi:10.1111/j.1469-8749.2002.tb00268.x

Cited by 121 publications

(7 citation statements)

References 31 publications

(43 reference statements)

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“…Randomized controlled studies focusing on the effects of different doses in children are few and most of them are confined to the calf muscles. abobotulinumtoxinA at 10 U/kg to 15 U/kg of per leg was found to be appropriate doses for the gastroc-soleus muscle [71][72][73].…”

Section: Base For Dose Calculationmentioning

confidence: 91%

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Over 25 Years of Pediatric Botulinum Toxin Treatments: What Have We Learned from Injection Techniques, Doses, Dilutions, and Recovery of Repeated Injections?

Sätilä

2020

Toxins

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Botulinum toxin type A (BTXA) has been used for over 25 years in the management of pediatric lower and upper limb hypertonia, with the first reports in 1993. The most common indication is the injection of the triceps surae muscle for the correction of spastic equinus gait in children with cerebral palsy. The upper limb injection goals include improvements in function, better positioning of the arm, and facilitating the ease of care. Neurotoxin type A is the most widely used serotype in the pediatric population. After being injected into muscle, the release of acetylcholine at cholinergic nerve endings is blocked, and a temporary denervation and atrophy ensues. Targeting the correct muscle close to the neuromuscular junctions is considered essential and localization techniques have developed over time. However, each technique has its own limitations. The role of BTXA is flexible, but limited by the temporary mode of action as a focal spasticity treatment and the restrictions on the total dose deliverable per visit. As a mode of treatment, repeated BTXA injections are needed. This literature reviewed BTXA injection techniques, doses and dilutions, the recovery of muscles and the impact of repeated injections, with a focus on the pediatric population. Suggestions for future studies are also discussed.

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Section: Base For Dose Calculationmentioning

confidence: 91%

“…Table 2. The recommended dose ranges for muscles summarized from [3,5,6,11,14,[71][72][73]75,76,78]. Dilution.…”

Section: Base For Dose Calculationmentioning

confidence: 99%

Over 25 Years of Pediatric Botulinum Toxin Treatments: What Have We Learned from Injection Techniques, Doses, Dilutions, and Recovery of Repeated Injections?

Sätilä

2020

Toxins

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“…Intramuscular botulinum neurotoxin type-A (BoNT-A) injections result in a partial chemo-denervation of skeletal muscle [1] and are widely used in the management of focal spasticity in children with spastic cerebral palsy (CP) [2, 3]. The use of BoNT-A in children with spastic type CP is not considered to be a stand-alone treatment [4], and when combined with physiotherapy and the use of orthoses, may have a small to moderate effect on improving gait outcomes [5, 6] and functional capacity [7, 8] during the pharmaceutically active period (∼2–6 months). Clinically, repeated BoNT-A injections are believed to maintain the time that the BoNT-A is active within the target muscle and, therefore, delay muscle contracture more effectively, with the frequency of injection guided by clinical assessments.…”

Section: Introductionmentioning

confidence: 99%

The effects of botulinum toxin injection frequency on calf muscle growth in young children with spastic cerebral palsy: A 12-month prospective study

Barber

Hastings-Ison

Baker

et al. 2013

Journal of Children's Orthopaedics

101

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Purpose This study was a 12-month prospective investigation of changes in the medial gastrocnemius (MG) muscle morphology in children aged 2-5 years with spastic cerebral palsy (CP) who had received no previous intramuscular injections of botulinum neurotoxin type-A (BoNT-A) and were randomised to receive either single or multiple (three) BoNT-A injections to the gastrocsoleus. MG morphological changes were compared to age-matched typically developing (TD) peers. Methods Thirteen children with spastic CP with a mean age of 45 (15) months and 18 TD children with a mean age of 48 (14) months participated in the study. The principal outcome measures were MG muscle volume, fascicle length, pennation angle and physiological cross-sectional area (PCSA), which were obtained using 2D and 3D ultrasound.Results The single and multiple injection frequency groups significantly increased MG muscle volume at 12 months relative to the baseline by 13 and 15 %, respectively. There were no significant differences in the MG muscle volume 28.5 (12.3) versus 30.3 (3.8) ml, fascicle length 48.0 (10.4) versus 44.8 (1.2) mm or PCSA 7.0 (1.2) versus 6.6 (1.7) cm 2 between the single and multiple injection groups, respectively, at 12 months follow-up. The change in MG muscle volume in the single and multiple injection groups was significantly lower than the TD peers by 66 and 60 %, respectively. Interpretation In young children with spastic CP, naive to BoNT-A treatment, MG muscle growth over 12 months does not appear to be influenced by intramuscular BoNT-A injection frequency. However, MG muscle growth in the spastic CP groups was significantly lower than the agematched TD peers. It is unclear whether this is an effect of intramuscular BoNT-A injections or reduced growth rates in children with spastic CP in general. 123J Child Orthop (2013) 7:425-433 DOI 10.1007 investigations and longitudinal studies with multiple measurement time points are required in order to determine the influence of BoNT-A treatment on muscle physiological and mechanical growth factors in young children with spastic CP.

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“…Botulinum toxin A is an effective and safe treatment of spasticity in CP 7) . Particularly, for lower limb spasticity, botulinum toxin treatment was found to effectively reduce muscle tone and improve a passive range of movement.…”

Section: Introductionmentioning

confidence: 99%

Gait training using a hybrid assistive limb after botulinum toxin treatment for cerebral palsy: a case report

et al. 2021

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Hybrid Assistive Limb ® (HAL; Cyberdyne, Tsukuba, Japan) is a wearable robot that assists patients based on their voluntary movements. We report gait training with HAL after botulinum toxin treatment for spasticity of the lower limb in cerebral palsy (CP). [Participant and Methods] The participant was a 36 year-old male with spastic diplegia due to periventricular leukomalacia, with Gross Motor Function Classification System (GMFCS) level II. HAL training was performed in 20-minute sessions (3 sessions/week for 4 weeks). The outcome measures were range of motion, spasticity, walking ability, muscle strength, gross motor function measure (GMFM), Canadian Occupational Performance Measure (COPM), and Pediatric Evaluation of Disability Inventory measured before, immediately after, and one, two, and three months after HAL training. [Results] No adverse events were observed during training. After the HAL intervention, gait speed, step length, cadence, 6-min walking distance (6MD), knee extension strength, GMFM, and COPM increased, and Physiological Cost Index declined. Three months post-intervention, gait speed, step length, cadence, 6MD, and GMFM remained higher than those observed within the first two months. [Conclusion] Gait training with HAL can be a safe and feasible method for patients with CP who undergo botulinum toxin treatment to improve walking ability and motor function.

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Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double‐blind, placebo‐controlled, dose‐ranging study

Cited by 121 publications

References 31 publications

Over 25 Years of Pediatric Botulinum Toxin Treatments: What Have We Learned from Injection Techniques, Doses, Dilutions, and Recovery of Repeated Injections?

Over 25 Years of Pediatric Botulinum Toxin Treatments: What Have We Learned from Injection Techniques, Doses, Dilutions, and Recovery of Repeated Injections?

The effects of botulinum toxin injection frequency on calf muscle growth in young children with spastic cerebral palsy: A 12-month prospective study

Gait training using a hybrid assistive limb after botulinum toxin treatment for cerebral palsy: a case report

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