OBJECTIVE:Multicenter retrospective analysis of the Russian experience in the use of AbobotulinumtoxinA injections for the correction of chronic sialorrhea of various etiologies in children. MATERIAL AND METHODS:608 injections (from 1 to 5 repeated injections) of the AbobotulinumtoxinA into the salivary glands for 226 patients aged 2.0 to 17.8 years (Me - 5.1 years) with various neurological diseases and neurodevelopmental disorders in 12 Russian centers. RESULTS:In 180 patients (79.6%), AbobotulinumtoxinA was the first drug used to correct drooling. 177 (78.3%) children received combined injections into the salivary glands and body muscles to correct spasticity. The total doses of AbobotulinumtoxinA administered into the salivary glands during the first injection were (Med; min-max; 25-75%):150 U (7.7 U/kg); 30-400 U (1.9-27.3); 100-200 units (4.8-15.3). Doses to both parotid glands - 80 units (4.1 units/kg); 18-250 U (0.8-15.4 U/kg); 60-120 U (2.7-8.5 U/kg); in both submandibular - 70 U (3.3 U/kg); 12-160 U (0.5-13.6 U/kg); 40-80 U (2.1-6.1 U/kg). After the first injection of AbobotulinumtoxinA, a significant decrease in salivation was observed in 212 cases (93.8%). The effect lasted for an average of 4.9 months (0.5 to 24 months). Changes in the Drooling Impact Scale and subjective duration of effect were not significantly different after repeated injections. Adverse events were noted in 30 (13.3%) cases and persisted up to 2-3 weeks after injection. CONCLUSION:AbobotulinumtoxinA injections have shown effectiveness and safety in the correction of chronic sialorrhea in children, also in combination with concomitant spasticity treatment. Further research is needed to determine the optimal dose and treatment protocols.

One of the modern components of complex rehabilitation of patients with spasticity is the use of botulinum toxin type A (BTA) preparations. International experience with the use of botulinum therapy in children spans more than 30 years. Abobotulinum toxin A has been used to treat spasticity since 1994. Clinical studies have shown the high efficacy of abobotulinumtoxin A in relieving spasticity of the lower and upper extremities in cerebral palsy (CP) and other disorders, which is associated with a significant increase in muscle tone, thereby increasing motor skills and achieving individual patient goals. The article presents a consensus of Russian experts on the approach to selecting target muscles and calculating the dose of abobotulinumtoxin A in multilevel injections, and discusses the planning of repeat injections, ethical and legal aspects of botulinum therapy in children, the combination of botulinum therapy with other methods of correcting spasticity in CP, the use of BTA in dystonia and sialorrhea, and factors potentially influencing the effectiveness of botulinum therapy. This consensus summarizes the views of Russian experts on creating an injection protocol depending on individual clinical data and treatment goals, which can be used as a guide for practical work.

Spastic muscles in the pathological motor patterns may change at different ages that leads to the changes in anti-spastic treatment.OBJECTIVE:To study the specific patterns of spasticity in CP patients with level III according to the Gross Motor Function Classification System (GMFCS) in different age periods.MATERIAL AND METHODS:A retrospective analysis of injection protocols of Abobotulinum toxin A for 99 patients with bilateral spastic CP GMFCS III at the age of 2 to 12 years was performed. Spasticity patterns were evaluated according to the frequency of target muscle selection for the botulinum toxin A (Abobotulinum toxin A) injections.RESULTS:The equinus foot deformity (89.7%, 95%CI 72.8-97.2) and its combination with internal hip rotation (79.3%, 95% CI 61.3-90.5) and/or hip adduction (65.5%, 95% CI 47.3-80.2) were the main lower extremity spasticity pattern for the patients aged 2 to 4 years. Between 4 and 6 years, there was the decrease in injections to the gastrocnemius muscle (75%, 95% CI 52.8-89.2), and less to the m. gracilis (70%, 95% CI 47.9-85.7) and hip adductors (55% 95 CI 34.2-74.2). In the 6-12 year old patients, the predominant spasticity patterns were internal hip rotation (80%, 95% CI 66.8-88.9), adduction (54%, 95% CI 40.4-67.0) and knee flexion (66%, 95% CI 52.1-77.6). The leading upper extremity patterns at all observed ages were forearm pronation (70.7%, 95% CI 61.1-78.8) and elbow flexion (47.5%, 95% CI 37.9-57.2). The frequency of injections to these muscles slightly decreased in elder groups.CONCLUSIONS:CP GMFCS III patients demonstrate age-related changes of the spasticity patterns both in lower and upper extremities. These changes and typical spastic muscles should be taken into account during the rehabilitation and botulinum toxin treatment planning, as well as in the detection and prevention of the orthopaedic complications.

OBJECTIVE:To evaluate the most typical target muscles and dosages for the first and repeated botulinum toxin A (BTA) injections in cerebral palsy (CP) patients with severe motor deficit - GMFCS IV-V.MATERIAL AND METHODS:A retrospective analysis of 677 protocols of the first and repeated Abobotulinumtoxin A (AboA) injections in 333 patients with CP GMFCS IV and V, aged 1 to 18 years, was carried out.RESULTS:Ninety-seven percent of patients received multilevel injections. In the lower extremities the most typical target muscles were: m.gracilis - 221 (66.4%) patients, hip adductors - 164 (49.2%), medial hamstring - 144 (43.2%). In the upper extremities the most typical muscles were: m.pronator teres - 237 (71.2%) patients, m.biceps brachii+m.brachialis - 197 (59.2%). The total dosages of AboA and dosages for every target muscle were calculated. Several patients required high dosages (more than 30 U/kg of AboA). Higher dosages per kg were used in younger children and for repeated injections. The age-related evolution of spastic patterns was described. Adverse events were observed in 36 cases (5.3% of all injections).CONCLUSION:The majority of patients with GMFCS IV-V required multilevel BTA injections in high dosages, especially in young age. Described selection of target muscles and dosages of AboA could be taken into account as a practical experience and reference for the BTA therapy in GMFCS IV-V patients.

OBJECTIVE:A retrospective analysis of the experience of using Incobotulinum toxin A injections for the treatment of spasticity in children with cerebral palsy (CP).MATERIAL AND METHODS:One hundred and eighty-five children with spastic forms of CP, including 114 boys (61,6%), were studied. The average age of the patients was 3,8±2,5 years; the average weight was 14,2±6,9. The patients received injections of Incobotulinum toxin A according to registered indications or recommendations of a consultation of specialists and voluntary informed consent of the patient's representative. At least 1 point decrease of muscle tone according to the modified Ashworth scale was used as a criterion of the antispastic effect of Incobotulinum toxin A.RESULTS:The total dose of Incobotulinum toxin A for the whole group of patients with CP was 154,5±67,7 U and 11,6±4,7 U per kg/body weight. The gracilis muscle (65,4% of cases, 95%CI 58,1-72,2) and the gastrocnemius muscle (49,4% of cases, 95%CI 41,8-56,6) were the most frequently injected targets in the lower extremities, and the pronator teres muscle (58,9% of cases, 95%CI 51,5-66,1) - in the upper extremities. Adverse events were observed in 13 patients (7,0%). They were mild in 9 patients and moderate in 4 patients.CONCLUSION:Our data confirmed the effectiveness and safety of Incobotulinum toxin A injections in spastic CP. The calculated average doses of Incobotulinum toxin A for target muscles and the frequency of different spasticity patterns could serve as a reference for the botulinum therapy planning.

Botulinum toxin A (BTA) injections are an effective method of spasticity treatment in cerebral palsy (CP) but still there are a lot of questions about the selection of target muscles. The article summarizes currently accepted approaches to the goal setting and prioritizing in CP botulinum toxin therapy according to the form of CP, GMFCS level, age, spasticity level and other factors. The authors discuss the Goal Attainment Scale (GAS) and its possibilities in the BTA injections planning and evaluation of the results. Attention is also paid to the 'key muscle concept' in the multilevel spasticity treatment in CP and the additional factors that can influence the effectiveness of injections. The above approaches to the detection of patients' problems and setting of BTA treatment goals can help to prevent serious mistakes and disappointment in this effective method of treatment.

Background and aims The spasticity is a major clinical sign of cerebral palsy (CP). The most effective and safe method of local spasticity decrease is the botulinum toxin A (BTA) therapy (evidence level A). Studying of early BTA injections in complex rehabilitation of children with CP is relevant due to the detection of wide range of secondary orthopedic problems in patients with early and severe spasticity. The objective was to determine the most common spasticity patterns for botulinum toxin therapy in patients with cerebral palsy under 2 years and to calculate the BoNT-A mean effective dose for the first injection. Patients and methods 60 patients (38 boys, 22 girls) aged from 15 up to 23 months (median age 21 months) with spastic forms of CP. Among all patients 20 had tetraparesis, 30 – diplegia, 10 – hemiparesis. The prevalence and intensity of muscle hypertonia was estimated in every limb functional segment with the Modified Ashworth scale (MAS). Injections were performed ‘off-label’ after the written consent of parents or representatives and with the agreement of the local independent ethics committee. Ultrasound control and Onabotulinum Toxin A were used in this study. Results Spasticity patterns were divided as shown below: forearm pronation in 51 patients (85%), equinus foot deformity — 47 (78,3%), hip adduction and internal rotation — 41 (68,3%), elbow flexion — 39 (65%), hip adduction — 33 (55%), pollex adduction — 21 (35%), rectus syndrome — 11 (18,3%), shoulder adduction and internal rotation — 10 (16,7%), elbow extension — 8 (13,3%), in 5% and less were knee flexion, wrist flexion, fingers flexion. Regardless of early age 57 (95%) patients required multi-level injections. The total dosage for all patients ranged 50–230 U (4,8–23 U/kg). In each injected muscle tone reduced for at least 1 MAS point. Ranges of Onabotulinum Toxin A dosage per muscle are presented in the Poster. Discussion Definition of the most essential spasticity patterns and their influence on the child movement development is among the key points for the target muscle selection during BTA therapy. Presented dosage ranges allowed us to reach significant decrease of spasticity in all patients.

AIM:To assess the safety and clinical and neurophysiological efficacy of xeomin in children with spastic equinus and equinovarus foot deformity in cerebral palsy.MATERIAL AND METHODS:Sixty-four patients with spastic forms of cerebral palsy (levels I-IV on the GMFCS) were enrolled into this multi-center open-label comparative randomized trial. The patients were administered xeomin or botox once, each drug being administered to 32 patients. Efficacy was evaluated based on clinical characteristics (the modified Ashworth scale, goniometry) and electromyography data. The subjects were observed for 3 months (90±7 days) after injections. The incidence, severity and intensity of adverse events (AE) was also determined.RESULTS:Treatment with xeomin according to the suggested protocol has proven its high clinical efficacy. The efficacy was demonstrated by significant, stable and long-term decrease in the gastrocnemius muscle tone: in the xeomin group, the score on the modified Ashworth scale decreased from 2.6±0.49 points at baseline to 1.8±0.54 points (р<0.000001, paired t-test; р<0.000004, Wilcoxon test). In the botox group, this score decreased from 2.4±0.56 points to 1.6±0.45 points (р<0.000001, paired t-test; р<0.000002, Wilcoxon test). The increased range of ankle joint movements at passive and voluntary feet extension. In the xeomin group, the significant proportion of patients (45.1%) moved to the group of lower spasticity defined as less than two score points on the modified Ashworth scale. The clinical data fully matched the changes in electromyography parameters, which were characterized by the lower amplitude and area of the target muscle (lateral and medial gastrocnemius heads) M-responses. AE developed in three patients (9.4%) administered xeomin and in two patients (6.3%) administered botox. The AE recorded in the study are described in the recommendations on the use of xeomin and botox. In three cases (50.0%), AE intensity was determined as mild, in the remaining three cases (50.0%) as moderate.CONCLUSION:The results have shown the safety and efficacy of xeomin in the treatment of gastrocnemius spasticity in pediatric patients with cerebral palsy. These data are confirmed by the lack of significant differences in any clinical or electromyography parameters with the results in the reference group administered botox.

Traumatic brain injury (TBI) is one of the main reasons of death and disability in children and adolescents in Russia and abroad. Spasticity is a frequent outcome of the TBI that influences on the rehabilitation prognosis, degree of movement disorders and quality of life after trauma. Early spasticity correction and complex rehabilitation lead to the optimal recovery and prevent secondary complications. This review presents the current data about the prognostic role of the spasticity in children after TBI, methods of its correction and their scientific evidence. Limitations and challenges of per-oral antispastic agents are described especially for the patients with local spasticity. Attention is focused on the methods of treatment of local hypertonus, in particular botulinum toxin A (BTA) injections proved to be effective in adults with acquired brain injury. The article summarizes the results of international investigations, systematic reviews and consensus statements about the efficacy and safety of botulinum toxin treatment in children after the TBI. The authors describe an algorithm of the optimal patient selection and goal setting for BTA injections in children with acquired brain injury.

The first year of life is crucial in the mental and physical development of a baby. Harmonious motor development of a healthy child depends on many factors, including the type of feeding and the position of feeding, because the child of the first year of life spends up to a third of the day eating. Objective to evaluate the relationship between the position of feeding in infants and the harmonicity of their motor development. patients and methods: the study involved 52 healthy children at the age of 10 months. Children were divided into groups depending on the type of feeding and the basic body position during feeding: 34% of children breast fed (group 1) with the location of the child lying on one side most of the time, 33% mixed (group 2) equally on the side and half-sitting, 33% bottle feeding (group 3) – half-sitting on the arms of their mothers. Children in these groups did not differ significantly in weight and growth. Harmonicity of motor development was measured according to the Scale of early motor development (SED), created in our Centre. This Scale is based on the principles and points of V. Vojta motor ontogenesis. According to the SED, the maximum score of motor development at 10 months is 26 points. Motor skills of the infants were measured by a physiotherapist. Results The medians of the SED scores in the groups were: Me1=25, Me2=23, Me3=22. In the group of the infants with natural feeding we observed the most harmonious motor development, which could be due to the baby’s position during the feeding. Conclusions Position of the baby during the natural feeding creates favourable conditions for the realisation of the physiological motor development and could be recommended for the use during mixed and bottle feeding.

Injections of botulinum toxin type A (BTA) are regarded as one of the basic methods to treat cerebral palsy (CP). The article discusses issues unique mechanism of action of botulinum toxin type A injections, double sensomotor mechanism of action of the drug OnabotulinumtoxinA, noninterchangeability of BTA drugs, evidence of efficacy and safety of the use of BTA for children with cerebral palsy, accuracy control of BTA injections, selection of muscle targets, assess the effectiveness of botulinum toxin therapy, etc. To the therapy used in cases where the manifestations of spasticity in cerebral palsy become significant and negative influence on the functional activity and motor development of the child. Injections of botulinum toxin type A in cerebral palsy are usually applied from the age of 2 years, and this treatment is indicated for 50-75% of patients depending on the level of motor abilities by GMFCS scale. If this treatment is not used in presence of indications, it is possible to say that the treatment is carried out not in full and the patient is deprived of the proven effective therapeutic approach.

Background: The contemporary application of Botulinum toxin A (BTA) in cerebral palsy (CP) implies multilevel injections both in on-label and off-label muscles. However, there is no single international opinion on the effective and safe dosages, target muscles, and intervals between the injections.Objective: Our aim was to analyze the Russian multicenter independent experience of single and repeated multilevel injections of Abobotulinum toxin А in patients with spastic forms of CP.Methods: 8 independent referral CP-centers (10 hospitals) in different regions of Russia. Authors evaluated intervals between the injections, dosages of the BTA for the whole procedure, for the body mass, for the each muscle, and functional segment of the extremities.Results: 1872 protocols of effective BTA injections (1–14 repeated injections) for 724 patients with spastic CP were included. The age of the patients was between 8 months to 17 years 4 months at the beginning of the treatment (with a mean of 3 years 10 months). Multilevel BTA injections were indicated for the majority (n = 634, 87.6%) of the patients in all the centers. The medians of the dosages for the first BTA injection were between 30–31 U/kg (500 U), the repeated injections doses up to 45 U/kg (1000 U) (in most centers). The median intervals between the repeated injections were 180–200 days in 484 (66.9%) patients and 140–180 days in 157 (24.7%) patients. In 2 centers, children with GMFCS IV–V were injected more often than others.Conclusion: Multilevel BTA injections were indicated for the most patients. The initial dose of Abobotulinum toxin A was 30–31 U/kg. The repeated injections dose could increase up to 40 U/kg. The repeated injections were done in 140–200 days after the previous injection.

Spasticity treatment is one of the key aspects of the contemporary cerebral palsy (CP) rehabilitation that influences on the effectiveness of other methods. The paper presents the first Russian document that unites the recommendations for the BTA treatment of CP and could be used as the guideline for the multilevel injections. The Russian consensus on the multilevel botulinum toxin A (BTA) treatment of spastic CP is based on the international data and the results of national studies. The authors describe typical CP spasticity patterns in the upper and lower extremities, give recommended intervals for the BTA (Abobotulinum toxin A) dosages for the whole injection procedure and for the separate muscles. The method of dosage calculation for functional segments is also described. Attention is paid to the frequency, optimal intervals between the repeated injections and the whole duration of BTA treatment. The authors discuss effectiveness and safety of BTA, factors that potentially influence the results of the injections, including ultrasound and electromyography control, and indications for the continuation and termination of treatment.

AIM:To analyze the efficacy and safety of dose ranges of abobotulinum toxin A (BTA) for multilevel injections into upper and lower extremity muscles in children with spastic forms of cerebral palsy (CP).MATERIAL AND METHODS:We analyzed retrospectively multilevel BTA injections for 216 patients, aged from 2 to 17 years. Children received 1-6 repeated injections and complex physiotherapy. Patients were classified according to the GMFCS. Treatment results were evaluated with the modified Ashworth and Tardieu scales.RESULTS:Multilevel BTA injections were indicated for the most (89/8%) of the patients with spastic forms of CP, and in most of them the total dosage exceeded 30 U/kg. In the bilateral forms of CP, the total dosage (U and U/kg) was higher compared to the unilateral forms. Doses for each muscle in U/kg were similar in all CP forms. The total doses of BTA and the intervals between the repeated injections were stable for each patient.CONCLUSION:The dose ranges suggested for CP are effective and safe for the reduction of spasticity in several functional segments of upper and lower extremities in one treatment session.

Background. Drooling (sialorrhea) is a complex medical and social problem of patients with cerebral palsy (CP). During the last decade many methods for drooling correction in CP are under active development.Aim: to evaluate the effectiveness and safety of the first and repeated injections of botulinum toxin A (BTA) for correcting drooling in children with CP.Methods. 13 children (2 years — 14 years 7 months) with spastic forms of CP and drooling resistant to non-drug treatment. Drooling was evaluated with the Drooling Impact Scale — DIS before, 1, 3 and 6 months after the BTA injections. Parotid and submandibular salivary glands were injected under ultrasound control with Dysport — 1 group (5 children) or Botox — 2 group (8 children). The total dose of Dysport for the all glands was 120–320 U (3,8–14,5 U/kg), Botox — 30–100 U (2,5–4,5 U/kg). The median of the basic DIS index was 77 (64–90) points in the first group and 58 (53–66) points in the second group.Results. One month after the BTA injections the DIS index decreased by 20 and more points in 6 (42,2%) patients, by 10–19 points in 7 (53,8%) children. There were no persistent side effects and no difference in the BTA effectiveness between the two groups. The mean decrease of DIS was 30% in both groups. 3 months after the injections 2 patients (15,4%) kept 20 points decrease of the DIS index, 6 patients (46,2%) demonstrated 10 points decrease. 6 months after injections nearly all patients returned to the basic level of drooling. Repeated injections of the BTA demonstrated the same tendency and duration of the DIS changes. There was no significant correlation between the GMFCS level and the drooling intensity.Conclusion. BTA injections into salivary glands of children with CP was an effective and safe method of drooling correction with the maximum effect taking place 2–4 weeks after the injections and a stable effect — 3 months after the injections.

Cerebral palsy (CP) is one of the most serious outcomes of the perinatal lesion of central nervous system and the most common reason for neurological disability in children. Being the key cause of pathological dynamic stereotypes that frequently result in pathological posture and contractures, spasticity is critically important for CP. The use of botulinum toxin type A (BTA) in complex treatment 2-6 years old CP patients allows significantly to improve motor abilities, help to change the surgical procedure, delay or even avoid some types of surgery. For elder children the use of BTA allows to improve local motor impairment. The treatment of spasticity in CP with BTA is safe (evidence level A) and highly effective (evidence level A). It leads to the positive change of pathological dynamic stereotype, significantly improves gait, decreases muscle tone with Ashworth and Tardeu scales and rises the gross motor function score. Our own experience of onabotulinumtoxinA treatment as a part of complex therapy in 68 patients with spastic forms of CP demonstrates the significant improvement of motor function, most noticeable in younger patients(early pre-school age) with GMFS I-III.