Effects of different dilutions of botulinum toxin type A treatment for children with cerebral palsy with spastic ankle plantarflexor: a randomized controlled trial.
OBJECTIVE
The aim of this study was to investigate the influence of different volumes of saline vehicle on the effects of botulinum toxin type A in reducing ankle plantarflexor spasticity and improving gait pattern in children with cerebral palsy.


METHODS
Children with cerebral palsy having ankle plantarflexor spasticity were recruited. They were divided randomly into 2 groups. Botulinum toxin type A mixed with 2 ml or 8 ml saline was injected into the gastrocnemius in each group. Passive range of movement of ankle joint, Modified Ashworth Scale, and results of 3-dimensional motion analysis obtained at pre-treatment, 4, 12, and 24 weeks after treatment were compared.


RESULTS
Ankle dorsiflexion was increased and ankle plantarflexor spasticity was decreased significantly after botulinum toxin type A treatment. Linear parameters were generally improved, and these improvements persisted until 12-24 weeks. The ankle dorsiflexion angle in the stance phase was also increased, and this increase was maintained until 24 weeks, as revealed by 3-dimensional gait analysis. However, no significantly different effect of varying the amount of saline vehicle was detected.


CONCLUSIONS
Botulinum toxin type A improved physical findings and gait pattern in patients with cerebral palsy. The volume of saline mixed with botulinum toxin type A did not result in significant differences in physical evaluation or gait analysis. However, the large-volume group revealed side-effects more frequently and showed no clinical benefits compared with the small-volume group. We conclude that 2 ml of dilution is preferable for botulinum toxin type A treatment in children.
Department of Physical Medicine and Rehabilitation, Wooridul Spine Hospital, Seoul, Korea.
Jung Hwan
JH
Lee
In Young
IY
Sung
Jong Yoon
JY
Yoo
Eun Ha
EH
Park
Song Rae
SR
Park
D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D002547:Cerebral Palsy / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005684:Gait / Q000502:physiology; D006801:Humans; D008297:Male; D009128:Muscle Spasticity / Q000188:drug therapy; D012965:Sodium Chloride / Q000008:administration & dosage; D016896:Treatment Outcome
D012965:Sodium Chloride; D019274:Botulinum Toxins, Type A