In a limited number of studies over the past seven years, positive results following intramuscular infusions of Allototoxin A (AlA) have been reported to temporarily improve localized spasticity in children with cerebral palsy (CP). However, the absolute feasibility of this method for long-term functional results in their kinetic evolution has not yet been substantiated.
The purpose of this prospective study is to evaluate the functional motor benefits of children with CP. in the first year after ALA infusions.
Material – Methods:
38 children with spastic type OP were selected. (tetraplegia 10, diplopia 23, hemiplegia 5) aged 3-9 years (mean = 4.5 years) under physiotherapy, without indication of orthopedic surgery. The purpose of the intervention was to assist, improve or normalize one of the basic motor functions: seating, standing, walking, running, depending on the degree of malfunction of each child in the GMFM Classification System for CP. AlA (Dysport, UK) at a maximum dose of 40 Ukgr per child (Dysp Bot 3-4: 1) was used for 4-12 predetermined infusions of 1-6 selected spinal muscles of the lower limbs when clinically or neurodegenerately detected. The children were examined by a pediatric neurologist, orthopedist and physiotherapist before the infusions and in 1st, 3rd, 6th, 9th and 12th months later.
Rated:
1) clinical parameters such as degree of Ashworth spasticity and passive range of motion in joints with angiometry; and
2) functional variables in 5 subgroups of mobility during the GMFM test video surveillance.
Results:
Injections were well tolerated with mild transient side effects in 4 children (10.5%) in the first week. The local action of AlA appeared 2-4 days after the infusion. Substantial subjective changes were observed mainly on day 6–10 or the day after, whereas children continued on PV. Ideal outcome (improvement of clinical parameters, achievement of functional goals and maintenance beyond 9 months) was found in 5 of 38 children (13%) all premature, 3-4 years old with dyspnea. Moderate benefits (significant initial improvement of up to 3 months of clinical parameters and achievement of operational goals between 3-6 months further changes) showed 23 children (60.5%) with various forms of OP (quadriplegia 3/10, bipolar 16/23, hemiplegia 5/5). Minor change (minimal improvement of clinical parameters at 1st month with no temporary functional benefit) was in 2 children (5.2%) with severe quadriplegia (2/10) and mental retardation.
Conclusion:
ALA infusions can provide at least a six-month, significant improvement in the motor development of most children with CP, provided that candidates for intervention based on the form of motor dysfunction and congenital problems are correctly selected.