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Background: Klippel–Feil disease is a condition characterized by a defect in the spine, consisting of the fusion or non-separation of two or more vertebrae of the cervical tract. It affects 1 in every 50,000 newborns, and the pathogenesis remains unknown to date, although the role of certain genes that are involved in segmentation processes is being studied. A single case of a genetic Myosin Heavy Chain 3 (MYH3) mutation is described here. Affected patients are typically distinguished by a relatively short neck, which leads to limited mobility, a low hairline, and obesity; they may also experience various other health issues. The common occurrence of comorbidities further diminishes the quality of life of these young individuals. Methods: The following case report describes the synergistic effect of Incobotulinum toxin type A and physiotherapy in a 7-year-old patient with MYH3 mutation-related Klippel–Feil syndrome (KFS) complicated by bilateral paraplegia to improve the spasticity condition of the lower limbs. To assess improvements over time, the patient underwent rating scales to determine spasticity (Modified Ashworth Scale: MAS), the neck's range of motion (ROM), and muscle tone by using MyotonPro®. Specifically, measurements were taken on the day of the first medical examination (T0), the month after the injection and the startup of therapeutic exercise (T1), at three months (T2), and then once a month for a total of 6 months (T3, T4, and T5). Results: This therapeutic approach resulted in highly satisfactory outcomes for the child's well-being, which was maintained until the sixth month and was accompanied by a complete absence of any side effects. [ABSTRACT FROM AUTHOR]

Stiff-person syndrome is rare and disabling autoimmune condition that most frequently affects women, with no real predisposition by race. Diagnosis is often arduous, which is why patients concomitantly suffer from anxiety and depression. To date, drug therapy is based on the use of benzodiazepines, barbiturates, and baclofen. Refractory cases are treated with intravenous immunoglobulin, plasmapheresis, B lymphocyte depletion with rituximab, and even the implantation of intrathecal baclofen devices. Botulinum toxin injection is frequently used, even if it still has an unclear role in the literature. Our case report aims to demonstrate the efficacy of a combined treatment of botulinum toxin and therapeutic exercise in a 65-year-old patient with biceps brachii muscle hypertonia and diffuse spasms of the axial musculature, using rating scales such as the Numeric Rating Scale (NRS) and Modified Ashworth Scale (MAS), joint range of motion (ROM) measurement, and muscle dynamic stiffness mensuration, which is performed by using the MyotonPro®. All the assessments were conducted at the first evaluation (T0), soon after the combined treatment with botulin toxin and therapeutic exercise (T1), three months (T2), six months (T3), and eight months after the botulinum toxin injection (T4). The patient demonstrated benefits for more than 6 months with no side effects. The combined therapy of botulinum toxin and therapeutic exercise had an excellent result in our patient. [ABSTRACT FROM AUTHOR]

A strong correlation has been reported between patient-reported quality of life (QoL) and the investigator-rated Disability Assessment Scale (DAS) in patients with spasticity. The current analysis evaluates the effect of incobotulinumtoxinA on QoL-related outcomes (limb position abnormality, as well as dressing- and hygiene-related disability, measured with the DAS) in adults with upper limb spasticity, using pooled data from six studies. Separate analyses for each DAS domain were performed using data from patients with disabilities for that domain (DAS score ≥1). Results showed that a significantly greater proportion of incobotulinumtoxinA-treated compared with placebo-treated patients achieved a ≥1-point reduction from baseline in each of the DAS domains (improvement) 4 weeks after the first injection. The benefits of incobotulinumtoxinA were observed regardless of the baseline severity of DAS impairment and of the time elapsed since stroke. The effects of incobotulinumtoxinA 4 weeks after injection were maintained or enhanced over multiple injection cycles for all three DAS domains, supporting the use of repeated injection cycles to provide sustained QoL benefit. IncobotulinumtoxinA represents an important treatment option to achieve better QoL-related outcomes for patients with upper limb spasticity, irrespective of the duration of their condition. [ABSTRACT FROM AUTHOR]

Objective: The primary objective of this paper is to assess whether the use of 200 units of abobotulinum in the pectoralis major and subscapularis muscles modifies the pain complaint assessed using the visual analog scale in subjects with shoulder pain after the onset of spastic hemiplegia due to cerebrovascular disease when compared to the application of a placebo to the same muscles. Design: A prospective, double-blind, randomized, and placebo-controlled clinical trial study in two different rehabilitation centers. Setting: Two distinct outpatient neurological rehabilitation services. Participants: Patients older than 18 years who were included presented upper limb spasticity resulting from ischemic or hemorrhagic stroke and a diagnosis of Painful Hemiplegic Shoulder Syndrome (PHSS) that was independent of motor dominance. Interventions: Patients were divided into two groups, one of them underwent the application of botulinum toxin (TXB-A) in the pectoralis major and subscapularis muscles, at a total dose of 400 U. Main Outcome Measure: Patients were assessed for a change in pain using the Visual Analog Scale (VAS) for at least 13 mm. Results: An improvement in pain and spasticity levels in both groups, more intense in the toxin group, but without statistical significance. The comparison between the groups showed a reduction in pain by VAS (p = 0.52). Conclusions: The use of botulinum toxin in the subscapularis and pectoralis major muscles resulted in a reduction in shoulder pain in spastic hemiplegic patients without statistical significance. [ABSTRACT FROM AUTHOR]

(1) Background: The evaluation of muscles with spasticity using ultrasound elastography has attracted attention recently, and the shear wave velocity (SWV) technique can measure the mechanical properties of tissues objectively and quantitatively. The purpose of this study was to evaluate the effect of using SWV to assess the effect of Botulinum toxin type A (BoNT-A) treatment in adult patients with post-stroke lower limb spasticity. (2) Methods: We assessed the modified Ashworth Scale, the modified Tardieu Scale, and SWV at rest and after stretching before and at 1 month after BoNT-A treatment in 10 adult participants with post-stroke lower limb spasticity. (3) Results: Significant changes in SWV of the ankle joint in maximum dorsiflexion to the extent possible (SWV stretched) were observed after BoNT-A treatment. SWV stretched was positively correlated with joint range of motion. Participants whose joint range of motion did not improve (i.e., gastrocnemius medialis muscle (GCM) extension distance did not change) had significantly more reductions in SWV stretched after BoNT-A treatment. (4) Conclusions: Our results suggest that the SWV measurements may serve as a quantitative assessment to determine the effect of the BoNT-A treatment in adult stroke patients. SWV measurements to assess GCM spasticity should consider the effects of tension, material properties and activation level of muscles. The challenge is to measure SWV with matching limb positions in patients without contractures. [ABSTRACT FROM AUTHOR]

Background: Phenol and botulinum toxin type A (BTX-A) injections are two options for treating spasticity with the ability to select a specific spastic muscle and determine the dosage based on spasticity degree. This study intends to compare the efficacy of BTX-A vs. phenol blockade in treating lower limb spasticity and to evaluate the performance improvement in gross motor functional outcomes among adult patients with upper motor neuron (UMN) lesions. Methods: This randomized, double-blind clinical trial of 28 spastic lower limb adult patients with UMN was diagnosed between March 1, 2017, to April 30, 2019. Patients were randomized in a 1:1 ratio to a "BTX-A injections" or a "Phenol injections" group. The outcomes were measured through assessment spasticity by the Modified Ashworth Scale (MAS), active range of motion (AROM) of lower limb joint by a goniometer, Verbal Rating Scale (VRS), Visual Analog Scale (VAS), and Penn Spasm Frequency Scale (PSFS) as a baseline and post-injection follow-up at 24 hours, 3 weeks, and 3 months. Results: All 28 randomized patients were analyzed. No significant difference between the two study arms, neither in demographic characteristics nor in MAS, AROM, VRS, VAS, and PSFS parameters prior to the procedures. AROM showed a significant decrease from baseline throughout the study in the phenol group. While in the BTX-A group, they improved significantly at 3 weeks; no more improvement was observed at 3 months, and the differences were statistically significant (p < 0.05). The reduction in MAS, VRS, VAS, and PSFS was statistically significant in each group at 24 hours, 3 weeks, and 3 months after the injection (p < 0.05). However, the differences were not significant between the phenol and BTX-A groups (p > 0.05), except for PSFS at the 3 months of follow-up in the Phenol group (p = 0.01). The need for re-injection at 6 months and 9 months was that 5 patients vs. 0 patients (p = 0.01) and 8 patients vs. 3 patients (p = 0.04) in the BTX-A and phenol groups, respectively, were statistically significant. Conclusion: Phenol injection showed superior treatment effects in AROM, decreased spasm degree based on PSFS at 3 months, and less-frequent re-injection rate compared to BTX-A injections in adult patients with UMN lesions. However, both phenol and BTX-A injections effectively reduce spasticity without significant differences in efficacy and adverse effects. Future studies must be conducted with a longer duration of follow-up, and larger sample sizes better to compare both drugs' effectiveness and side effects. [ABSTRACT FROM AUTHOR]

Abstract Background It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies. Aim To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke. Method An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome. Conclusion Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term. Trial Registration ACTRN12615000616572 (12/06/2015).

Objectives: This study aimed to analyze the effect of oral baclofen treatment and botulinum toxin type A (BT-A) injection treatment in hemiplegic patients with spasticity on the electromyographic nociceptive flexor reflex (NFR) threshold. Patients and methods: A total of 29 spastic hemiplegic patients (20 males, 9 females; mean age: 52.9±10.1; range, 27 to 64) with Modified Ashworth Scale (MAS) grades 2-4 were included in the prospective, randomized study between May 2018 and March 2019. The patients were divided into two groups: the BT-A group consisted of 15 patients that underwent a BT-A injection and the baclofen group consisted of 14 patients treated with baclofen. Modified Ashworth Scale, Visual Analog Scale (VAS), Barthel daily life activity index, and NFR threshold values were used in the evaluation of the patients before and after the treatment at the sixth week. The motor evaluation of the patients was performed using Brunnstrom motor staging. Results: In both groups, MAS and VAS values decreased significantly compared to pretreatment (p<0.05). There was a significant decrease in ankle MAS score (p<0.001) and a significant increase in Brunnstrom hand recovery stages in the BT-A group compared to pretreatment (p=0.020). While the NFR threshold statistically significantly increased in the baclofen group compared to pretreatment (p=0.007), there was no significant change in the BT-A group (p=0.669). Conclusion: These results suggest that BT-A injections do not cause a significant change in the NFR threshold in the treatment of spasticity. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea. Methods: This prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12. Results: There was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial. Conclusion: NABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients. [ABSTRACT FROM AUTHOR]

Objective: The primary objective of this paper is to assess whether the use of 200 units of abobotulinum in the pectoralis major and subscapularis muscles modifies the pain complaint assessed using the visual analog scale in subjects with shoulder pain after the onset of spastic hemiplegia due to cerebrovascular disease when compared to the application of a placebo to the same muscles. Design: A prospective, double-blind, randomized, and placebo-controlled clinical trial study in two different rehabilitation centers. Setting: Two distinct outpatient neurological rehabilitation services. Participants: Patients older than 18 years who were included presented upper limb spasticity resulting from ischemic or hemorrhagic stroke and a diagnosis of Painful Hemiplegic Shoulder Syndrome (PHSS) that was independent of motor dominance. Interventions: Patients were divided into two groups, one of them underwent the application of botulinum toxin (TXB-A) in the pectoralis major and subscapularis muscles, at a total dose of 400 U. Main Outcome Measure: Patients were assessed for a change in pain using the Visual Analog Scale (VAS) for at least 13 mm. Results: An improvement in pain and spasticity levels in both groups, more intense in the toxin group, but without statistical significance. The comparison between the groups showed a reduction in pain by VAS (p = 0.52). Conclusions: The use of botulinum toxin in the subscapularis and pectoralis major muscles resulted in a reduction in shoulder pain in spastic hemiplegic patients without statistical significance.

In the past few years, there was a great interest in the use of higher doses of botulinum toxin type A, especially in case of upper and lower limb severe spasticity. To date, only one prospective, non-randomized, single-arm, multicenter, open-label, dose-titration study with the employment of incobotulinum toxin up to 800 U has been published, and the authors investigated safety and tolerability. Other researches showed efficacy in spasticity reduction, but there is a lack of evidence about the reasons to use high doses of botulinum toxin. This short communication highlights the benefits of higher doses for subjects with upper and lower limb spasticity. [ABSTRACT FROM AUTHOR]

Background: It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies.Aim: To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke.Method: An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life.Results: By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome.Conclusion: Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term.Trial Registration: ACTRN12615000616572 (12/06/2015). [ABSTRACT FROM AUTHOR]

Investigate the effect of botulinum toxin type-A (BoNT-A) on spasticity and motor performance in children with Cerebral Palsy (CP) related to Congenital Zika Syndrome (CZS). Prospective longitudinal observational study of 34 children with CP referred for BoNT-A treatment. Outcomes were evaluated with a muscle tone assessment scale (Modified Ashworth Scale – MAS) and the Patients' Global Impression of Improvement (PGI-I) scale. Mean age was 32.06 ± 3.07 months and 85% were classified as Gross Motor Function Classification System (GMFCS) V. Primitive reflexes were present in 56% of the sample. The majority of the parents (97.9%) reported improvement in range of motion or reduction in spasticity after treatment with botulinum toxin. No side effects were recorded. When compared to the baseline, median reduction in the MAS was 0.5 (IQR = 0). The findings of this study suggest that BoNT-A may effectively promote functional improvements and reduce muscle tone, improving the child's and family's quality of life. [ABSTRACT FROM AUTHOR]

We examined the biceps brachii and the medial head of the gastrocnemius muscles on the affected side of two patients with post-stroke spasticity. Sonoelastography was used to evaluate the changes in spastic muscles before treatment; and 2, 4, 8 and 12 weeks after treatment with botulinum toxin Type A. Modified Ashworth scale (MAS), and the passive range of motion of the elbow and the ankle joints, before and after the treatment, were also evaluated. Both patients engaged in outpatient rehabilitation and a home exercise program focused on stretching throughout the assessment period. Sonoelastography enabled the visualization of the hardness of the spastic muscles using imaging and color scaling, and an objective evaluation of the hardness of the spastic muscles was performed by measuring the strain ratio(SR) using an acoustic coupler. Both patients showed reductions in MAS score and SR for both the biceps brachii and medial gastrocnemius head at two and four weeks after injection with botulinum toxin Type A: subsequently, however, these two measures followed different patterns through week 12 of evaluation. SR is an objective measure of spastic muscle hardness based on physical changes in their viscoelasticity, making it qualitatively different from the subjective ratings of the MAS. Sonoelastography offers clinicians a useful tool for visually and objectively monitoring complex pathologies characterized by muscle spasticity at all points in their course: before botulinum therapy and associated rehabilitation, during follow-up, and at the time of repeated injection(s). The information provided could help to select which muscle(s) to target for treatments, and to determine effective dosages. Further accumulation of cases is needed to ascertain and establish useful roles for this tool in clinical practice. [ABSTRACT FROM AUTHOR]

Serious adverse events (serious AEs) following the therapeutic use of Botulinum Toxin Type A (BoNT-A) are infrequent. Children with pediatric spasticity often have comorbidities that can cloud causation around an adverse event (AE). If a serious AE occurs, clear documentation of information sharing and informed consent as well as the provider-patient relationship are critical to minimizing litigation risks. Reviewing the litigation that has occurred following BoNT-A for pediatric spasticity can offer insight into how providers' perspectives regarding this intervention may differ from those of the public who might serve as jurists. This article offers suggestions for content sharing during the consent process to optimize patient understanding about potential adverse events. [ABSTRACT FROM AUTHOR]

The definition of cerebral palsy (CP) includes a group of permanent developmental disorders of movement and posture that cause activity limitation due to non-progressive lesions in the developing fetal or newborn infant brain. The most common type of CP is spastic cerebral palsy (SCP). One of the primary aims in treating children with SCP is to enable them to perform functional activities, to stimulate effective movement, to prevent deformities of bone and joint system, and to reduce pain. Limb deformities are the most prominent manifestation in children with SCP, greatly preventing them from performing activities of daily living. The reduction of spasticity and prevention of contractures, the development of performing functional activities in the full potential, as well as delays in performing surgical intervention, have dramatically increased the use of botulinum toxin type A (BTA) in treating children with CP lately. It is known as the most potent neurotoxin found in nature that reduces spasticity after application and results in irreversible denervation at the neuromuscular junction, while functional recovery is time limited. In that time period it is necessary to evaluate the functional motor status of a child, clearly and realistically define aims in cooperation with parents, and apply adequate rehabilitation protocol. The international consensus statement in 2010 defined the protocol, dosage, the site of application, and rehabilitation protocol. After being used for two and a half decades, certain dilemmas arose, particularly those regarding rehabilitation effects after BTA application. [ABSTRACT FROM AUTHOR]

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.

The botulinum therapy remains the most effective and safe method for reducing local spasticity in patients with cerebral palsy (CP). However, the list of indications for injections of botulinum toxin type A (BTA) in cerebral palsy is limited both in terms of target muscles and the treatment initiation age. In this regard, doctors are guided by the data of clinical studies, reviews and consensuses of experts, which are advisory in nature. One of the most urgent issues in the modern CP botulinum therapy is the evaluation of risks andbenefits of initiating injections at an early age (up to 2 years) in order to prevent orthopedic complications and stimulate the optimal motor development of a child. The review analyzes the history of the development of modern approaches to the use of botulinum therapy in cerebral palsy and the tactics of selecting target muscles and doses for multilevel injections. The authors focus on the latest international data on the feasibility and safety of reducing the admissible initiation age for botulinum therapy in cerebral palsy. The results from the studies of the effect of the early initiation of BTA injections on motor development, formation of secondary orthopedic complications in children under 2 years of age, and morphological changes in the neuromotor apparatus in animal experiments are presented. The concept of «key muscles» is considered in detail as one of the possible reference points in the planning of safe andeffective early injections.

Single case report. A previous study clarified that spasticity and motor function were improved by combined treatment with botulinum toxin type A (BTX) injection and 1-Hz repetitive transcranial magnetic stimulation (rTMS) with intensive motor training at 4 weeks after injection. However, it is not clear whether 1-Hz rTMS with intensive motor training immediately after BTX injection also improves spasticity and motor function in stroke patients. The purpose of this case report is to test the short- and long-term effects of BTX injection and rTMS with intensive motor training on the spasticity, motor function, and usefulness of the paretic hand in a stroke patient. A 64-year-old male, who suffered from a right cerebral hemorrhage 53 months previously, participated in the present study. BTX was injected into the spastic muscles of the affected upper limb. He then received the new protocol for a total of 24 sessions. The Modified Ashworth Scale (MAS), Fugl-Meyer Assessment (FMA), and Motor Activity Log, consisting of the amount of use and quality of movement scales, were assessed before and immediately after BTX injection, at discharge, and monthly for up to 5 months after discharge. For the short-term effects of the therapy, the MAS scores of the elbow and wrist, FMA score, and quality of movement score improved. For the long-term effects of the therapy, the MAS score of the fingers, FMA score, and amount of use score improved for up to 5 months after discharge. The present case report showed the improvement of all assessments performed in the short and/or long term and suggest the possibility of shortening the intervention period of combined therapy of BTX and rTMS with intensive motor training. • 1-Hz repetitive transcranial magnetic stimulation with rehabilitation immediately after botulinum toxin type A injection in a stroke patient. • The spasticity, motor function, and usefulness of the paretic hand improved. • This is a possibility of shortening the intervention period of combined therapy. [ABSTRACT FROM AUTHOR]

BACKGROUND: The ideal time of botulinum toxin A for treating lower limb spasm of stoke patients still remains controversial. OBJECTIVE: To evaluate whether the outcomes after botulinum toxin A injection for plantar flexion spasticity can be different according to stroke chronicity. METHODS: Ninety-seven patients with metatarsal flexor spasm after stroke were enrolled, 6 cases of loss to follow up. The study was in accordance with the ethics requirement of the First Affiliated Hospital of Guangxi Medical University. The patients were allocated into three groups based on onset time: early-term (within 6 months, n=30), middle-term (6-12 months, n=29), and late-term (1-2 years, n=32). The patients received 100 U botulinum toxin A injection at the gastrocnemius and soleus (for patients combined with varus, 80 U botulinum toxin A injection at the tibialis posterior) under ultrasound guidance, two injection points at each muscle. After injection, conventional rehabilitation training was conducted, once daily, six times per week for 8 consecutive weeks. The Modified Ashworth Scale, 10-meter walking test and Functional Ambulation Category were used for outcome evaluation at 2, 4 and 8 weeks after administration. RESULTS AND CONCLUSION: (1) The gait and spasm degree after administration were improved in all groups. Significant improvement in the Modified Ashworth Scale (P < 0.001) was observed at 2 week post-injection. (2) There was a significant difference in Functional Ambulation Category (P < 0.001) in all three groups at 4 and 8 weeks post-injection. (3) The early-term group of the 10-m walking test produced a great change in gait speed. (4) These results indicate that for patients with plantar flexor spasticity after stroke at different stages, botulinum toxin A treatment is expected to continuously reduce muscle tension and improve the gait. The effect is especially pronounced in patients who have been treated within 6 months. [ABSTRACT FROM AUTHOR]

• Botulinum toxin type A (BoNT-A) injection is an effective treatment for lower-limb spasticity. • A wide range of adjunct therapies has been proposed to improve the BoNT-A effect, but the role of electrical stimulation (ES) of antagonist muscles is still unclear. • Our results do not support the use of ES of antagonist muscles after BoNT-A injection to plantar flexors muscles for post-stroke spasticity. • ES should probably be applied to injected muscles only, to boost the BoNT-A effect. Botulinum toxin type A (BoNT-A) injection is an effective treatment for lower-limb spasticity and should be offered as first-line treatment for focal manifestations. Although its possible role has been hypothesized, the efficacy of electrical stimulation (ES) of antagonists of the injected muscles for improving clinical outcome after BoNT-A injection remains to be established. This randomized single-blind pilot study aimed to investigate the efficacy of ES of antagonist muscles as adjunct treatment after BoNT-A injection to plantar flexor muscles in hemiplegic patients with spastic equinus foot. After BoNT-A injection at triceps surae, patients were randomly allocated to 2 groups: group 1, single ES session on injected muscles plus 5 sessions of ES on antagonist muscles, and group 2, single ES session on injected muscles alone. Both groups underwent daily physical therapy for 60 min for 2 weeks (5 days/week). Assessments were performed before treatment (T 0) and at 10 days (T 1), 20 days (T 2), and 90 days (T 3) after treatment. Our primary outcome was gait velocity at a comfortable speed at T 2 (10-m walk test [10MWT]). The following were secondary outcomes: triceps surae spasticity (Modified Ashworth Scale), ankle passive range of motion (pROM), strength of tibialis anterior muscle, and 2-min walk test (2MWT). The 30 patients enrolled were randomly allocated to the 2 groups: 15 in group 1 and 15 in group 2. At T 1 , T 2 and T 3 , both groups showed a significant reduction in muscle tone and an increase in ankle pROM (P < 0.05). At T 2 and T 3 , both groups showed a significant increase in 10MWT and 2MWT. The groups did not significantly differ in tibialis anterior strength or primary or secondary outcome measures. ES of antagonist muscles does not improve clinical outcomes in the post-stroke spastic equinus foot after BoNT-A injection. [ABSTRACT FROM AUTHOR]

Background: Botulinum neurotoxins type A (BoNT-As) are used in pediatric lower limb spasticity, which affects more than 2.5 million children worldwide. Botulinum neurotoxins type-A improve active function and delay musculoskeletal complications. The objective of this analysis was to evaluate the efficacy and safety of abobotulinumtoxinA versus other botulinum neurotoxins type A in pediatric spasticity, in the absence of head-to-head evidence. Methods: A systematic literature review was conducted to identify relevant randomized controlled trials. The evidence base was synthesized with Bayesian network meta-analyses. Outcomes analyzed included Modified Ashworth Scale, Tardieu Scale (TS) spasticity grade, and Goal Attainment Scale (standard mean difference only) at 12 weeks postinjection, and adverse events occurring during study periods. Results: Thirty-eight studies were identified, 10 of which met inclusion criteria for quantitative synthesis. On Modified Ashworth Scale, abobotulinumtoxinA 15 U/kg/leg was significantly more efficacious than onabotulinumtoxinA 4 U/kg/leg (–0.99 [–1.34, –0.64]) and onabotulinumtoxinA 4 U/kg/leg+casting (–0.81 [–1.16, –0.46]) and numerically better than onabotulinumtoxinA 8 U/kg (–0.40 [–0.67, –0.14]). AbobotulinumtoxinA 10 U/kg/leg was significantly more efficacious than onabotulinumtoxinA 4 U/kg/leg (±casting). On Goal Attainment Scale, abobotulinumtoxinA 15 U/kg/leg and 10 U/kg/leg were significantly more efficacious than onabotulinumtoxinA 12 U/kg/leg. On Tardieu Scale spasticity grade, abobotulinumtoxinA was comparable to other treatments. AbobotulinumtoxinA demonstrated adverse event rates comparable to all doses of onabotulinumtoxinA. Conclusions: In pediatric lower limb spasticity, abobotulinumtoxinA offered significant or numerical efficacy advantages on tone (Modified Ashworth Scale) and functional outcomes (Goal Attainment Scale), and comparable efficacy on Tardieu Scale spasticity grade. AbobotulinumtoxinA was comparable to onabotulinumtoxinA on tolerability. Results should be interpreted in the context of heterogeneity and sparsity of the evidence base. [ABSTRACT FROM AUTHOR]

Spasticity is a painful and disabling motor disorder that greatly contributes to the disability of a patient. When the spasticity is very noticeable and uncontrolled it endangers the patient, makes it difficult or impossible to perform everyday life activities, decreases the volume of movement, makes walking and sitting worse, causes pain and depression, distresses the dream, leads to contractures, luxation and decubitus wounds. Spasticity treatment is imperative for symptomatic therapies as it improves physical, mental and social habilitation/rehabilitation of patients, while saving the cost of further treatment. The pharmacological treatment of spasticity has a major contribution to the treatment of patients and is a great support to physical therapy. Among the most commonly used pharmacologic drugs, Botulinum toxin type A is used to block neuromuscular transmission and to treat spasticity, most commonly in children with cerebral palsy although its application is also found in numerous other states of spasticity. Subsequently followed by baclofen, primarily designed for the treatment of epilepsy where it proved unsuccessful, but was found to treat muscle spasticity. We also use benzodiazepines whose calming, relaxing and sleeping activity is based on the strengthening of gamma-butyric acid neuroprioride activity (GABA-A), then gabapentin that binds with high affinity to the α2δ (alpha-2-delta) subunit voltage-controlled calcium channel and it is believed that binding to the α2δ subunit causes inhibition of certain calcium channels and consequently has an anticonvulsive effect. There is also tizanidine which is an α-adrenergic receptor agonist of the central nervous system at the supraspinal and spinal levels. And at the end, there are also cannabinoids that are currently being heavily researched for the treatment of spasticity. [ABSTRACT FROM AUTHOR]

BACKGROUND: To assess treatment effect of lower limb botulinum toxin type A (BTX-A) in combination with physiotherapy approaches on gross motor functions in children with cerebral palsy compared with only physiotherapy treatment. OBJECTIVE: The purpose of this review was to analyze the efficacy botulinum toxin a lower limb injections in addition to physiotherapy approaches in children with cerebral palsy. METHODS: A literature search was conducted in the following databases: Cochrane, PEDro, PubMed, MEDLINE, AMED and EMBASE. The searches were limited to the period from July 2009 to July 2015. The intervention had to contain BTX-A into the lower limb plus physiotherapy approaches and be compared with only physiotherapy. The methodological quality and clinical relevance were independently assessed by the authors. RESULTS: The database search resulted in a total of 1521 studies, of which 4 (Level II of evidence) trials were included in this review. The population represented by were age between from 11 month to 15 years. Overall there were 153 children all diagnosed with CP (87 Male, 66 Female). CONCLUSIONS: The use of BTX-A injections in addition to physiotherapy approaches seems to have positive effect on spasticity and ROM. However, the question of whether the treatment of BTX-A plus physiotherapy has a greater improvement on functional capacity, such as gross motor function or gait parameter than only physiotherapy treatments, was inconclusive. Further investigation by rigorous studies is required. [ABSTRACT FROM AUTHOR]

Two randomized, placebo-controlled studies evaluated the pulmonary function safety of onabotulinumtoxinA (onabotA) for treatment of upper and/or lower limb spasticity. Patients with stable baseline respiratory status received one or two treatments with placebo, 240 U, or 360 U of onabotA. Pulmonary function tests, adverse events, and efficacy were measured at least every 6 weeks for 18 weeks (Study 1) or 30 weeks (Study 2). Study 1 enrolled 109 patients (n = 36–37/group) and Study 2 enrolled 155 patients (n = 48–54/group). Mean baseline forced vital capacity (FVC) was 76–78% of predicted per group in Study 1 and 71% of predicted per group in Study 2. In Study 1, change from baseline FVC values were significantly (p < 0.05) decreased vs. placebo at weeks 3 (240 U −57 mL vs. placebo +110 mL) and 12 (360 U −6 mL vs. +167 mL placebo). In Study 2, change from baseline FVC values were significantly decreased in the 360 U group vs. placebo at weeks 6 (−78 mL vs. +49 mL placebo), 13 (−60 mL vs. +119 mL placebo), 18 (−128 mL vs. +80 mL placebo), and 24 (−82 mL vs. +149 mL placebo). Individual pulmonary function-related adverse events were not correlated with PFT decreases. The most frequent pulmonary-related adverse events were nasopharyngitis (Study 1) and upper respiratory tract infection (Study 2). Ashworth scores were significantly improved at multiple time points in both studies. Injection of onabotA for spasticity in patients with decreased pulmonary function, at single and repeated doses of up to 360 U, was associated with small but statistically significant decreases in FVC or forced expiratory volume 1 s (FEV1) (>12% and 200 mL) that were subclinical and not correlated with any adverse clinical pulmonary events.

A prospective longitudinal analytical before and after study was performed in 12 pediatric patients between two and 18 years old with diagnosis of spastic cerebral palsy with limited communication, assessing the presence of pain by using the FLACC scale; the participants had indication for the administration of Botulinum Toxin type A for the control of spasticity. After this, the evaluation of the presence of pain was performed a week and a month after de administration of the myorelaxant material, in order to determine if there were any objective changes that may favor a better quality of life. Materials and methods: A Prospective longitudinal non-experimental analytical before and after for related samples study was performed in children between 0 and 18 years of age with a diagnosis of spastic cerebral palsy and presence of pain reported by their parents. The Tstudent statistical test was performed for related samples analyzing the results of the FLACC pain scale before and after the administration of Botulinum Toxin Type A. Results: A total of 15 patients were met, however, due the absence to controls and insufficient data provided by the parents, 3 cases were lost, obtaining a total of 12 patients included in the study, among them, by using the FLACC scale in the first assessment (FLACC1) seven patients (58.3%) evidenced the presence of moderate pain, four (33.3%) presented severe pain and one (8.3%) had mild pain; In the second assessment, one week after the administration of myorelaxant material (FLACC2), the results showed that four (33.3%) had moderate pain and eight (66.7%) had mild pain. Subsequently, in the third assessment, a month after the procedure (FLACC3), three (25%) of the patients presented moderate pain, eight (66.7%) had mild pain and one (8.3%) of them no longer presented any sign of pain. This showed that there are significant differences between pain values ?? before and after the application of myorelaxant material, suggesting the effectiveness of pain control with the administration of Botulinum Toxin type A. Conclusions: The application of the FLACC scale to patients with spastic cerebral palsy allows an objective assessment of the level of pain in patients with limited communication and the application of botulinum toxin as myorelaxant material have significant beneficial effects in reducing pain in this population group.

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.

Botulinum toxin type A (BoNT-A) is used in cerebral palsy (CP) for more than 20 years. Nevertheless, the unified protocol of injections and doses does not exist by now. The correct selection of target muscles for BoNT-A injections is based on the experience of the doctor, detailed analysis of neurological and orthopedic status of the patient, standard scales to evaluate motor potential of the patient. The article represents the detailed review of international clinical trials for multi-level use of BoNT-A in CP and recommendations on doses calculation. Based on our own observations of efficacy and safety of single-used doses of Botox we present the recommended dose ranges for upper and lower limb that led to clinically significant decrease of spasticity with no undesirable weakness. The review of clinical cases presents the doses per targeted muscle and total doses we used, they are advisory in nature.

Purpose This study investigated the sequential physical changes after botulinum toxin type A (BTX-A) injected in children with cerebral palsy. Methods Nine children with cerebral palsy were included. Measurements were performed before treatment and 4 weeks, 8 weeks, and 12 weeks after treatment. We used video-recorded gait in the sagittal plane. The maximum flexion and extension angles of the hip, knee and ankle joints, step length, gait speed, and observational gait were measured using the Foot Contact Scale (FCS) and the Physician’s Rating Scale (PRS). We also measured the lower limb range of motion (ROM), Modified Tardieu Scale (MTS), knee joint extension torque, and Gross Motor Function Measure-66 (GMFM-66). Results The ankle dorsiflexion ROM, GMFM-66, and the maximum dorsiflexion angle of the ankle during gait were significantly increased at 8 weeks after treatment, and knee joint extension torque was significantly increased at 12 weeks after treatment. Conclusion Maximum effects of BTX-A treatment do not occur during the early stage after treatment. Therefore, long-term intervention with rehabilitation between BTX-A treatment may be more effective than implementing rehabilitation for only a brief period. [ABSTRACT FROM AUTHOR]

Background. Spasticity is well known as one of the most common after stroke complications, providing a series of negative effects including decreased range of motion, muscle spasm, different levels of contracture, local pain in the affected area. Aims. Clinical-functional evaluation of the short and medium term effect of ultrasonographically guided injections with botulinum toxin type A (TxB-A) on the spasticity of the upper limb in post-stroke patients and the quantification of effects on international scales of spasticity and functionality. Methods. The groups studied were composed of 60 patients, which were divided based on the doses provided in each muscle of the hand and wrist flexors (250 IU versus 333 IU). Every patient received a total dose of 1000 IU of TxB-A. The parameters that were assessed were: Modified Ashworth Scale (MAS) and Activities of Daily Living Scale (ADL), international scales for spasticity and functionality. The moments evaluated were: T0 (the initial time - injection time), T1 (one month after the injection) and T2 (3 months from T0 or 2 months from T1). Results. Evaluation of MAS and ADL scales from T0 to T1 and T2 for the 250 IU group shows great improvements at T1 on both scales, MAS (<0.001) and ADL (<0.001), while maintaining the efficacy at T2, MAS (p-value 0.214 ), ADL (p-value 0.166). Evaluation of MAS and ADL scales from T0 to T1 and T2 for the 333 IU group also shows effective improvements on both scales at T1, MAS (<0.001), ADL (<0.001), and T2, MAS (0.849), ADL (0.013). Correlations between the two groups, 250 IU vs 333 IU, performed for each of the scales used in the study evidenced better results at T1 in favor of the 333 IU group on both MAS (p-value 0.034) and ADL score (p-value 0.078), with the proportion maintained in favor of the 333 IU group at T2, MAS (p-value 0.024), ADL (p-value 0.035). Conclusions. a) TxB-A is efficient as a prime line treatment for spasticity, helping the patients in the muscle neurorehabilitation effort; b) TxB A is effective in reducing spastic muscle tone (MAS); c) TxB A is a useful asset in managing hand function (ADL). [ABSTRACT FROM AUTHOR]

The aim of this study is to compare the treatment effectiveness of botulinum toxin type A (BTX-A) and phenol blocks in the management of lower limb spasticity and to measure improvement in gross motor functional outcome in children with cerebral palsy (CP). This is a hospital-based prospective, noncontrolled randomized study that took place in a tertiary care center. A total of 61 ambulatory children with CP spastic diplegia, aged from 4 to 10 years, were randomly divided into two groups and included in this study. Twenty-eight children with CP received BTX-A injections and 33 received phenol motor point blocks. The measures performed were as follows: outcome assessment spasticity by the Modified Ashworth scale (MAS), active range of motion (AROM) of lower limb joint by goniometer, and functional improvement by Gross Motor Function Measures (GMFM). Postinjection follow-up done at 2, 6, 12, 24, and 48 weeks. Significant improvement in reduction of spasticity, increased AROM of all joints of lower limbs, and improvement in functional outcome were observed in CP with spastic diplegia after BTX-A injections as compared with the phenol motor point block group. There was no significant side effect after BTX-A injections as compared with phenol injections. BTX-A injections showed superior treatment effects in the reduction of spasticity and improvement in AROM and functional outcome measures with spastic diplegia as compared with phenol blocks. BTX-A injections also revealed fewer clinical side effects and were well tolerated by children with CP. [ABSTRACT FROM AUTHOR]

Many neurological diseases (ischemic and hemorrhagic stroke, multiple sclerosis, infant cerebral palsy, spinal cord injuries, traumatic brain injury, and other cerebrovascular disorders) may cause muscle spasticity. Different therapeutic strategies have been proposed for the treatment of spasticity. One of the major treatments for tone modulation is botulinum toxin type A (BTX-A), performed in addition to other rehabilitation strategies based on individualized multidisciplinary programs aimed at achieving certain goals for each patient. Therapeutic plans must be precisely defined as they must balance the reduction of spastic hypertonia and retention of residual motor function. To perform and optimize the treatment, an accurate clinical and instrumental evaluation of spasticity is needed to determine how this symptom is invalidating and to choose the best doses, muscles and times of injection in each patient. We introduce an “appropriate treatment” and no “standard or high dosage treatment” concept based on our retrospective observational study on 120 patients lasting two years, according to the larger Therapeutic Index and Therapeutic Window of Incobotulinumtoxin A doses from 100 to 1000 units. We studied the efficiency and safety of this drug considering the clinical spasticity significance for specialist physicians and patients.

We evaluated the efficiency of botulinum toxin type A injection followed by a rehabilitation program including individual therapy, group therapy, and occupational therapy in cases of cerebral palsy with upper extremity involvement. A total of 29 injections were performed on 25 patients, and the patients were placed on rehabilitation program. At 3-month and 6-month assessments, there was a significant improvement in lateral grip strength, 9 Hole Peg test, Upper Limb Physician’s Rating Scale and pediatric functional independence measure total scores. There were significant decreases in active range of motion in elbow extension, supination, and wrist extension, and Modified Ashworth Scale in elbow flexion, elbow pronation, and wrist flexion at 6-week, 3-month, and 6-month assessments. Combination of group therapy with traditional therapy methods after injection is effective in cases of cerebral palsy with upper extremity involvement. [ABSTRACT FROM AUTHOR]