Does botulinum neurotoxin A make walking easier in children with cerebral palsy? A randomized clinical trial.

AIM: To assess the effect of single botulinum neurotoxin A (BoNT-A) injections into the calf muscles on the gross energy cost of walking in children with cerebral palsy (CP) and to evaluate the effect of BoNT-A on walking capacity, physical activity, perceived changes in mobility, and pain. METHOD: This was an industry-independent, randomized, quadruple-blind, placebo-controlled, multicentre trial (ClinicalTrials.gov registration: NCT02546999). Sixty-one children (33 male, median age [range] = 8 years [4-16 years]) with spastic CP and classified in Gross Motor Function Classification System (GMFCS) levels I and II allocated to single injections of either BoNT-A or 0.9% saline into the calf muscles. The main outcome was gross energy cost (J/kg/m); secondary outcomes were walking capacity, habitual physical activity, perceived change in mobility tasks, and calf pain at baseline, 4 weeks (P1), 12 weeks (P2), and 24 weeks (P3) after the injection. RESULTS: The mean change in energy cost did not differ significantly between groups at the primary time point P2 (-0.27 J/kg/m, 95% confidence interval - 0.91 to 0.36, p = 0.404), nor at P1 or P3. Regarding the secondary outcomes, there was some evidence of a larger reduction in pain intensity in the group given BoNT-A (p = 0.043). INTERPRETATION: One treatment with BoNT-A was not superior to placebo in making walking easier in children with CP classified in GMFCS levels I and II, at least in the short term. BoNT-A may have a pain-reducing effect.

Functional improvement of young children with cerebral palsy treated with integrated/intensive rehabilitation and botulinum toxin injections.

INTRODUCTION: Patients with cerebral palsy (CP) present mobility limitations altering their activity and participation in social life. The aim of this study was to assess changes in Gross Motor Function Classification System (GMFCS) and Functional Mobility Scale (FMS) in children with CP who received repeated BoNT-A injections within a rehabilitation treatment over a five-year follow-up period. MATERIAL AND METHODS: This retrospective, observational study included 200 consecutive children with bilateral CP (GMFCS I-IV). Annual assessments of the five-year follow-up period were analysed. RESULTS: The mean age of the patients at the beginning was 32.23 months (± 6.96). The GMFCS level improved in 67 (33.5%) (p < 0.001) and worsened in four (2%) children. In children with GMFCS III and IV levels, improvement was observed in 50% and 40%, respectively. FMS 5 and 50 metres improved in 54% and 52.5% of children respectively. CONCLUSIONS: Our study showed a significant, positive effect of integrated treatment on functional mobility in patients with CP.

Intermittent serial casting for wrist flexion deformity in children with spastic cerebral palsy: a randomized controlled trial.

AIM: To assess the efficacy of intermittent serial casting in conjunction with occupational therapy and botulinum neurotoxin A (BoNT-A) in children with cerebral palsy (CP) presenting spastic wrist flexion deformity. METHOD: This was a controlled, prospective study in which 34 children (19 females, 15 males; mean [SD] 11y [4y 6mo]) were randomly allocated to casting or control groups in a ratio of 2:1. Both groups were subjected to BoNT-A treatment and occupational therapy. The casting group additionally received a series of progressive casts intermittently for three consecutive weekends. Outcome measures consisted of passive range of motion (PROM) as assessed by goniometer, muscle tone by Modified Ashworth scale (MAS), and spasticity by Tardieu Scale. Assessments were done at baseline, week 4, and week 12. RESULTS: Baseline characteristics of casting and control groups were comparable. PROM, MAS, and Tardieu angle of catch (XV3) of the casting and control groups significantly improved after treatment (p<0.001 for all). Nevertheless the mean change from baseline MAS at week 12, mean changes from baseline PROM, Tardieu XV3, and the spasticity grade (Y) at week 4 and week 12 of the casting group showed statistical superiority over those of the control group (p<0.05 for all). INTERPRETATION: Children with CP presenting spastic wrist flexion deformity might gain additional benefits from supplementary intermittent serial casting as well as BoNT-A injections and occupational therapy. Serial casting could be considered as a complementary treatment to BoNT-A and occupational therapy in children with clinically significant PROM limitations.

Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.

AIM: To assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP). METHOD: This was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4. RESULTS: During cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively). INTERPRETATION: Treatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles. WHAT THIS PAPER ADDS: AbobotulinumtoxinA injections significantly reduced upper limb spasticity in children with cerebral palsy. Children treated with abobotulinumtoxinA and targeted home exercises showed global improvement and goal attainment. Benefits were sustained over 1 year with repeat cycles of abobotulinumtoxinA and home exercises. AbobotulinumtoxinA injections into the upper limb were well tolerated over 1 year.

Safety and efficacy of Botulinum toxin type A preparations in cerebral palsy - an evidence-based review.

The introduction of botulinum toxin more than 25 years ago for the management of paediatric lower and upper limb hypertonia has been a major advance. BoNT-A as a part of multimodal treatment supports motor development and improves function disturbed by spasticity or hypertonia. The aim of this paper was to compare the efficacy and safety of three major BoNT-A preparations present on the market: abo-, inco-, and onaobotulinumtoxinA in the treatment of children with cerebral palsy. Based on an analysis of the available literature, all three preparations have been established to reduce hypertonia in the upper and lower extremities, with some conflicting evidence regarding function. There were no differences in treatment safety, with a low incidence of adverse events which were mostly temporary and mild. Any form of universal conversion ratio between all preparations is not recommended.

Botulinum toxin type-A preparations are not the same medications - basic science (Part 1).

Botulinum neurotoxin type A (BoNT/A) formulations are widely used in clinical practice. Although they share a common mechanism of action resulting in presynaptic block in acetylocholine release, their structure and pharmacological properties demonstrate some similarities and many differences. Bioequivalence has been discussed since the onset of the clinical use of BoNT/A. In this review, we provide an update on the studies and compare the molecular structure, mechanisms of action, diffusion and spread, as well as immunogenicity and dose equivalence of onabotulinumtoxinA, abobotulinumtoxinA and incobotulinumtoxinA.

Botulinum toxin type-A preparations are not the same medications - clinical studies (Part 2).

The growing number of Botulinum neurotoxin type A (BoNT/A) preparations on the market has resulted in a search for pharmacological, clinical and pharmacoeconomic differences. Patients are occasionally switched from one botulinum toxin formulation to another. The aim of this paper was to review studies that have made direct comparisons of the three major BoNT/A preparations presently on the market: ona-, abo- and incobotulinumtoxinA. We also review the single medication Class I pivotal and occasionally Class II-IV studies, as well as recommendations and guidelines to show how effective doses have been adopted in well-established indications such as blepharospasm, hemifacial spasm, cervical dystonia and adult spasticity. Neither direct head-to-head studies nor single medication studies between all preparations allow the formation of universal conversion ratios. All preparations should be treated as distinct medications with respect to their summary of product characteristics when used in everyday practice.

Development of GO Move: A Website for Children With Unilateral Cerebral Palsy.

It is unknown if an online tool is wanted by therapists and parents of individuals with unilateral cerebral palsy (UCP) to support implementation of goal-directed home programs, and if wanted, the recommended features for the tool. The objective was to explore the experiences of therapists and parents who have implemented home programs, seek guidance on translating a paper-based home program toolbox into a mobile website, and develop the website. Qualitative descriptive methodology guided data collection using semi-structured interviews and thematic analysis, validated with field notes and member checking. A team science, iterative approach was used to integrate the themes into the development of the mobile website. Five primary themes including recommendations for the functionality, features, content, and naming of the mobile website were identified. Parents and therapists value home programs. Participants provided recommendations regarding content and features, and the GO Move mobile website was developed based on the recommendations.

Development of Go Move: A Website for Children With Unilateral Cerebral PalsyTherapists and parents of children with unilateral cerebral palsy were interviewed to understand their experience of home programs and gain input for creating a mobile website with information on goal setting and implementing home programs. The interviews provided valuable information about the functionality, features, content, and naming of the website. GO Move, a mobile website aimed to provide information on goal setting, activity selection, and tracking of exercises and activities in the home environment for children with unilateral cerebral palsy, was developed based on the information from the interviews.

Goal Attainment after Treatment with Abobotulinumtoxina and a Tailored Home Therapy Programme in Children with Upper Limb Spasticity: Descriptive, Exploratory Analysis of a Large Randomized, Controlled Study

OBJECTIVE: This exploratory analysis of a large, randomized, double-blind study (NCT02106351) describes the effect of treatment with abobotulinumtoxinA followed by a tailored home exercises therapy programme in enabling children with upper limb spasticity due to cerebral palsy to achieve their functional goals using goal attainment scaling (GAS). METHODS: Children with cerebral palsy and spasticity in ≥ 1 upper limb received up to 4 injection cycles of abobotulinumtoxinA (2 U/kg (cycle 1 only), 8U/kg and 16U/kg) into the elbow and wrist flexors and other upper limb muscles selected to support individual treatment goals. Children followed a home exercises therapy programme, which included stretches and exercises specifically chosen to facilitate goal achievement and engagement in activities. RESULTS: For cycle 1, most children had active function goals set as their primary goal (69.7% vs 19.2% passive function goals). GAS T- scores and goal responder rates at week 16 indicated that most types of primary goal were achieved at least as expected during cycle 1 (all groups). Primary goal GAS T-scores were generally maintained for the first 3 abobotulinumtoxinA treatment cycles. CONCLUSION: Most children with upper limb spasticity treated with repeat cycles of abobotulinumtoxinA supported by an individualized home exercises therapy programme achieved their functional goals.

Efficacy and safety of onabotulinumtoxinA with standardized physiotherapy for the treatment of pediatric lower limb spasticity: A randomized, placebo-controlled, phase III clinical trial.

BACKGROUND: Spasticity is common in cerebral palsy and can result in pain and diminished health-related quality of life. OBJECTIVE: To evaluate the safety and efficacy of onabotulinumtoxinA for lower limb spasticity treatment in children with cerebral palsy. METHODS: In this registrational phase 3, multinational, randomized, double-blind, placebo-controlled trial (NCT01603628), children (2-< 17 years) with cerebral palsy and ankle spasticity (Modified Ashworth Scale-Bohannon [MAS] score≥2) were randomized 1 : 1 : 1 to standardized physical therapy and onabotulinumtoxinA (4 or 8 U/kg), or placebo. Primary endpoint was average change from baseline at weeks 4 and 6 in MAS ankle score. Secondary endpoints included the Modified Tardieu Scale (MTS) and Global Attainment Scale (GAS). RESULTS: 381 participants were randomized. MAS scores averaged at weeks 4 and 6 were significantly reduced with both onabotulinumtoxinA doses (8 U/kg: -1.06, p = 0.010; 4 U/kg: -1.01, p = 0.033) versus placebo (-0.8). Significant improvements in average dynamic component of spasticity, measured by MTS, and in function, measured by GAS, were observed at several time points with both onabotulinumtoxinA doses versus placebo. Most adverse events were mild or moderate. CONCLUSIONS: OnabotulinumtoxinA was well tolerated and effective in reducing lower limb spasticity and improving functional outcomes versus placebo in children.

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children: SIPEXI.

BACKGROUND AND OBJECTIVES: This prospective phase III study (SIPEXI) investigated efficacy and safety of repeated injections of incobotulinumtoxinA (incoBoNT/A) for treatment of chronic sialorrhea (drooling) associated with neurological disorders (e.g., cerebral palsy, traumatic brain injury) and/or intellectual disability in children/adolescents. METHODS: The study enrolled 2-17-year-olds with sialorrhea due to neurological disorders and/or intellectual disability. Patients received body weight-dependent doses of incoBoNT/A (20 U to 75 U). A main period with 1 injection cycle (placebo-controlled, double-blind, 6-17-year-olds) was followed by an open-label extension with up to 3 further cycles. An additional cohort of 2-5-year-olds received active treatment throughout the study. Co-primary endpoints were the change in unstimulated salivary flow rate (uSFR) from baseline to week 4, and the carers' global impression of change scale (GICS) rating at week 4. Adverse events were recorded. RESULTS: In the main period, 220 patients aged 6-17 years were randomized and treated (148 patients in incoBoNT/A group, 72 patients in placebo group). 35 patients aged 2-5 years received incoBoNT/A (no placebo). 214 patients aged 6-17 years and 33 patients aged 2-5 years continued treatment in the open-label extension period. For the 6-17-year-olds, a significant difference between incoBoNT/A and placebo was seen in the mean uSFR decrease (difference: -0.06 g/min; p = 0.0012) and the carers' GICS rating (difference: 0.28 points; p = 0.032) at week 4, in favor of active treatment. The secondary endpoints consistently supported these results. A sustained benefit was observed during the extension. Incidences of adverse events were comparable between incoBoNT/A and placebo and did not increase notably with repeated injections. The most common adverse events were respiratory infections. Efficacy and safety were also favorable in the uncontrolled cohort of 2-5-year-olds. DISCUSSION: Both co-primary efficacy endpoints were reached and superiority of incoBoNT/A over placebo was confirmed. IncoBoNT/A (up to 75 U, up to 4 cycles) is an effective and well-tolerated treatment for sialorrhea associated with neurological disorders in children. STUDY REGISTRATIONS: Clinicaltrials.gov: NCT02270736 (www.clinicaltrials.gov/ct2/show/results/NCT02270736); EU Clinical Trials Register: 2013-004532-30 (www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004532-30). CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that injection of incobotulinumtoxinA decreases drooling in children aged 6-17 years with neurological disorders.

Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy.

Background: Guidelines recommend botulinum toxin-A in pediatric upper limb spasticity as part of routine practice. Appropriate dosing is a prerequisite for treatment success and it is important that injectors have an understanding on how to tailor dosing within a safe and effective range. We report upper limb dosing data from a phase 3 study of abobotulinumtoxinA injections in children with cerebral palsy. Methods: This was a double-blind, repeat-treatment study (NCT02106351). In Cycle 1, children were randomized to abobotulinumtoxinA at 2 U/kg control dose or clinically relevant 8 U/kg or 16 U/kg doses. Doses were divided between the primary target muscle group (PTMG, wrist or elbow flexors) and additional muscles tailored to clinical presentation. During Cycles 2-4, children received doses of 8 U/kg or 16 U/kg and investigators could change the PTMG and other muscles to be injected. Injection of muscles in the other upper limb and lower limbs was also permitted in cycles 2-4, with the total body dose not to exceed 30 U/kg or 1,000 U (whichever was lower) in the case of upper and lower limb treatment. Results: 212 children were randomized, of which 210 received ≥1 abobotulinumtoxinA injection. Per protocol, the elbow and wrist flexors were the most commonly injected upper limb muscles. Across all 4 cycles, the brachialis was injected in 89.5% of children (dose range 0.8-6 U/kg), the brachioradialis in 83.8% (0.4-3 U/kg), the flexor carpi ulnaris in 82.4% (0.5-3 U/kg) and the flexor carpi radialis in 79.5% (0.5-4 U/kg). Other frequently injected upper limb muscles were the pronator teres(70.0%, 0.3-3 U/kg). adductor pollicis (54.3%, 0.3-1 U/kg), pronator quadratus (44.8%, 0.1-2 U/kg), flexor digitorum superficialis (39.0%, 0.5-4 U/kg), flexor digitorum profundus (28.6%, 0.5-2 U), flexor pollicis brevis/opponens pollicis (27.6%, 0.3-1 U/kg) and biceps (27.1%, 0.5-6 U/kg). AbobotulinumtoxinA was well-tolerated at these doses; muscular weakness was reported in 4.3% of children in the 8 U/kg group and 5.7% in the 16 U/kg group. Conclusions: These data provide information on the pattern of injected muscles and dose ranges used in this study, which were well-tolerated. Per protocol, most children received injections into the elbow and wrist flexors. However, there was a wide variety of other upper limb muscles injected as physicians tailored injection patterns to clinical need.

[Are botulinum toxin type A preparations really the same medication? A comparison of three botulinum toxin A for variations in labelled neurological indications]. / Czy wszystkie preparaty toksyny botulinowej typu A sa takie same? Porównanie trzech preparatów toksyny botulinowej typu A w zarejestrowanych wskazaniach w neurologii.

Recently, the list of clinical applications of botulinum toxin type A (BTX-A) enlarged. This medication is used not only by neurologists, but also by medical rehabilitation specialists, urologists, proctologists, and migraine and aesthetic medicine specialists. Currently, there are three commercially available BTX-A preparations available: Botox, Dysport and Xeomin. They have similar mechanisms of action but their chemical formulation, clinical potency, migration and diffusion as well as safety profile seem to be different. This may result in problems of bioequivalence, not only clinical but also economic ones. The authors reviewed the available clinical and laboratory studies on neurological indications labelled in Poland. Each BTX-A formulation should be treated as a different medication and used cautiously according to the individual range of dosages established in clinical trials.

Efficacy of Repeat AbobotulinumtoxinA (Dysport®) Injections in Improving Gait in Children with Spastic Cerebral Palsy.

Purpose: This secondary analysis of a randomized, double-blind study plus open-label extension (NCT01249417/NCT01251380) evaluated the efficacy of abobotulinumtoxinA versus placebo in improving gait pattern in children with dynamic equinus due to cerebral palsy (CP) as assessed by the observational gait scale (OGS). Methods: Ambulatory children with CP (N = 241, aged 2-17) and dynamic equinus were randomized to treatment with abobotulinumtoxinA (10 or 15U/kg/leg) or placebo injected into the gastrocsoleus. All children received abobotulinumtoxinA in the open-label phase. Results: In the double-blind phase, abobotulinumtoxinA significantly improved OGS total scores versus placebo at Week 4 (treatment effect vs. placebo: 10U/kg/leg: 1.5 [0.7, 2.3], p = .0003; 15U/kg/leg: 1.1 [0.3, 1.9], p = .01). In the open-label phase, treatment with abobotulinumtoxinA continued to improve the OGS score at the same magnitude as seen in the double-blind study. Conclusion: Repeat treatment with abobotulinumtoxinA improved gait in children with dynamic equinus.

AbobotulinumtoxinA Efficacy and Safety in Children With Equinus Foot Previously Treated With Botulinum Toxin.

BACKGROUND: The effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous injections has remained largely unexplored. METHODS: We present subgroup analyses of a phase III study conducted in ambulatory children (aged two to 17) with spastic equinus foot. Patients were randomized to single doses of abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injected into the gastrocnemius-soleus complex (one or both legs). The first analysis was prespecified to review the effect of abobotulinumtoxinA in children previously treated with botulinum toxin versus those children new to the treatment; a second post hoc analysis evaluated the effect of abobotulinumtoxinA in children who changed botulinum toxin formulation. RESULTS: Of the 241 randomized patients, 113 had previously received botulinum toxin, including 86 who had been treated with another formulation. In both analyses, muscle tone (Modified Ashworth Scale) and the Physicians Global Assessment, at week 4, improved with abobotulinumtoxinA treatment versus placebo, regardless of baseline botulinum toxin status. Placebo responses in patients new to treatment were consistently higher than in the previously treated group. CONCLUSIONS: These results demonstrate similar abobotulinumtoxinA efficacy and safety profiles in children with spasticity who are new to botulinum toxin treatment and those children who were previously treated. The efficacy and safety of abobotulinumtoxinA treatment in these previously treated patients were comparable with the overall trial population, indicating that doses of 10 and 15 U/kg/leg are suitable starting doses for children with spasticity regardless of the previous botulinum toxin preparation used.

Safety and Efficacy of Repeat Open-Label AbobotulinumtoxinA Treatment in Pediatric Cerebral Palsy.

This was a prospective, repeat-treatment, open-label study (NCT01251380) of abobotulinumtoxinA for the management of lower limb spasticity in children who had completed a double-blind study. Children (2-17 years) received injections into the gastrocnemius-soleus complex, and other distal and proximal muscles as required (maximum total dose per injection cycle: 30 U/kg or 1000U). A total of 216 of the 241 double-blind patients entered the extension study and 207 received ≥1 open label injection into the gastrocnemius-soleus; 17-24% of patients also had injections into the hamstrings. The most frequent adverse events were related to common childhood infections and the most frequent treatment-related adverse event was injection site pain (n = 10). There was no evidence of a cumulative effect on adverse events. Sustained significant clinical improvements in muscle tone (Modified Ashworth Scale), spasticity (Tardieu Scale), overall clinical benefit (Physicians Global Assessment), and goal attainment (Goal Attainment Scale) were also observed across treatment cycles.

AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial.

BACKGROUND: Although botulinum toxin is a well-established treatment of focal spasticity in cerebral palsy, most trials have been small, and few have simultaneously assessed measures of muscle tone and clinical benefit. METHODS: Global, randomized, controlled study to assess the efficacy and safety of abobotulinumtoxinA versus placebo in cerebral palsy children with dynamic equinus foot deformity. Patients were randomized (1:1:1) to abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injections into the gastrocnemius-soleus complex (1 or both legs injected). In the primary hierarchical analysis, demonstration of benefit for each dose required superiority to placebo on the primary (change in Modified Ashworth Scale from baseline to week 4) and first key secondary (Physician's Global Assessment at week 4) end points. RESULTS: Two hundred and forty-one patients were randomized, and 226 completed the study; the intention to treat population included 235 patients (98%). At week 4, Modified Ashworth Scale scores significantly improved with abobotulinumtoxinA; mean (95% confidence interval) treatment differences versus placebo were -0.49 (-0.75 to -0.23; P = .0002) for 15 U/kg/leg and -0.38 (-0.64 to -0.13; P = .003) for 10 U/kg/leg. The Physician's Global Assessment treatment differences versus placebo of 0.77 (0.45 to 1.10) for 15 U/kg/leg and 0.82 (0.50 to 1.14) for 10 U/kg/leg were also significant (both Ps < .0001). The most common treatment-related adverse event was muscular weakness (10 U/Kg/leg = 2; placebo = 1). CONCLUSIONS: AbobotulinumtoxinA improves muscle tone in children with dynamic equinus resulting in an improved overall clinical impression and is well tolerated.

Botulin toxin A in the treatment of dynamic equinovarus foot in cerebral palsied children.

Background. Contracture of the triceps in the calf occurs in most CP children especially those with diplegia and spastic hemiplegia. The purpose of our research was to evaluate the effective of TB-A in the treatment of these contractures and the associated disturbances of the dynamic position of the foot in CP children.
Material and methods. Thirty five CP children (19 with diplegia and 16 with hemiplegia) received botulinum toxin A (TBX-A-Dysport) for the dynamic contracture of the triceps surae muscle and secondary equinovarus foot deformity. These children ranged in age from 2-11 years (mean 4.6). Previous conservative treatment had failed to alleviate these conditions. Goniometric measurements of the passive range of motion and the evaluation of dynamie equinovarus foot were performed prior to injection of BTX-A to 54 gastrocnemius muscles, and again at 2, 6, and 12 weeks post injection.
Results. The results showed high effectiveness for TBX-A, e.g. marked reduction in equinovarity in 47 and 49 ankle joints (68%- 78%) at 2 and 6 weeks respectively, and in 19 joints (35%) at 12 weeks post-treatment, and moderate reduction in 12 (22%), 8 (15%) and 14 (26%) joints respectively. These improvements were statistically significant. In some children the positive effect was present up to 16 and 20 weeks post injection. No change was found on follow-up in 5 ankle joints (9%) at 2 weeks and in 7 (13%) at 6 and 12 weeks. Reversion to baseline scores was observed in 14 ankle joints (26%). The TB-A therapy was cllosely integrated with physiotherapy and the use of AFO orthosis when necessary.
Conclusions. Botulin toxin therapy is effective in the treatment contractures of the triceps of the calf and equinovarus foot in children with cerebral palsy.

Functional effects of robotic-assisted locomotor treadmill thearapy in children with cerebral palsy.

OBJECTIVE: The aim of this study was to assess gait in children with spastic diplegic cerebral palsy rehabilitated with the use of Lokomat active orthosis. DESIGN: A randomized controlled trial. SUBJECTS: Fifty-two children with spastic diplegic cerebral palsy. METHODS: Temporospatial parameters of gait and selected kinematic parameters were assessed. Children from the study group used active orthosis in addition to following a programme of individual exercises. Children in the control group participated only in individual exercises. RESULTS: The difference between the initial and control examinations was statistically insignificant. After the programme was finished, there was a slight improvement in walking speed in both groups. Improvement in the mean walking speed was not significantly different between the groups (p = 0.5905). Range of motion decreased slightly in both groups, and the difference between mean amounts of change was not significant (p = 0.8676). There was significant improvement in maximal range of flexion in the hip joint (p = 0.0065) in the study. It was shown that with a decrease in the mean value of adduction in hip joint, the mean walking speed increased (r = -0.53, p = 0.0011). CONCLUSION: There are several limitations to this study, therefore these results should be regarded as preliminary. Further research consistent with the above indications is needed to investigate the impact of this new treatment option in patients with cerebral palsy.