Cerebral Palsy and Botulinum Toxin Clinical Trial
Official title:
SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY
Objectives. To study the short-term neurophysiological and clinical outcome of botulinum
toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring
uninjected muscles in children with cerebral palsy.
Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus
foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was
injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological
outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral
gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side
before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical
scales were assessed and video gait was analyzed at all three time points.
Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side
decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002).
Assessment at both time points after injections also showed that ankle spasticity had
diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved
(p<0.05).
Conclusion. Although BoNT-A injected at standard doses improves gait in children with
spastic equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for
cerebral palsy therefore needs individualizing according to the child's clinical features.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment