1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2. To assess the safety of Xeomin® use as compared to Botox® in this patient population
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"
Moscow, Russia
Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation
Moscow, Russia
Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation
Stavropol, Russia
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Time frame: From baseline to day 30
Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale
Time frame: From baseline up to day 90
Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
Electromyography: The amplitude of a compound muscle action potential (M-wave) is recorded. An electrical stimulation is considered supramaximal when the M-wave amplitude no longer increases while increasing the stimulus. The measurements include the M-wave amplitude and the negative peak area of the M-wave.
Time frame: From baseline up to day 90
Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior
Time frame: From baseline up to day 90
Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
Time frame: From baseline up to day 90
Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
GMFCS is a 5-level classification system that is a standardized observational instrument for children with CP developed to measure change in gross motor function over time.
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Time frame: From baseline up to day 90
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale
Time frame: Baseline up to day 90