Aim: To determine the effectiveness of botulin toxin A- (BTXA) treatment of spasticity in lower limbs of children with cerebral palsy (CP), and compare results with the traditional treatment. Patients and Methods: Study sample: 12 patients per group. Selection criteria: ambulatory patients of both sexes (age range, 2–8 yrs), with spastic diparetic or hemiparetic CP diagnosis, increased myostatic reflex and improved motor prepositioning and positioning of the feet, 1+ and 3 scores (modified Ashworth Scale) in the muscle groups under study (gemellus, 10 patients, and internal rectus, 1 patient). Design: Randomized clinical trial. Treatment: Patients received 5 U/kg BTXA injections per muscle (maximum dose: 400 U) at the beginning of the study and 16 weeks later. The informed consent of the patients was required in all instances. Variables evaluated: Functional improved prepositiong and positioning of the feet, evaluated by the modified Ashworth Scale, joint range of motion, active foot dorsiflexion, ambulation speed, step length and size, motor function (GMFM test), percentage of foot support, myostatic reflex and parents′ opinion. Results: Results from 17 patients (11 treated and 6 controls) who completed the study period are presented, age-range 2.25 – 7.33 yrs (x= 4.5 yrs). Ten cases corresponded to diparesis and 7 to hemiparesis. Follow-up: 32 weeks. The injection of gemellus resulted in improved Asworth scale scores (1 score), increased passive mobility (especially in quick movements) and increased plantar support. The myostatic reflex changed from 16.7 (95% CI, 8–25) at the beginning to –8 ( 95% CI, -26 – -10) 32 weeks later (p=0.002). There were no significant changes in the patient who received BTXA in the internal rectus. Parents from patients of the intervention group valued the marked (9 patients) and moderate (1 patient) improvements obtained. Conclusion: The use of BTXA is as effective as the traditional treatment for dynamic equinus gait. The results obtained in this long-term clinical randomized trial are promising but not conclusive, especially with reference to functional assessments.
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