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Background: Many studies in vitro compared the onset of action, maximum efficacy, and duration of botulinum toxin type A (BoNT/A) preparations. Objective: In this study, we analyzed the onset of action of BoNT/A preparation free of complexing proteins in patients with upper limb spasticity post stroke up to 30 days after treatment. Methods: 75 patients affected by Biceps Brachii spasticity were enrolled. Outcome measures were instrumental muscle tone modification (myometric measurement), improvement of Modified Ashworth Scale (MAS), improvement of elbow’s passive extension, and improvement of compound muscle action potential (cMAP) evaluated by electroneurography. We analyzed data at t0 (pre-injection), t1 (1 day after), t2 (7 days after), t3 (14 days after), and t4 (30 days after). Results: All measurements decreased at t2, t3, and t4 with initial improvement at t2 and maximum improvement at t4; no statistical difference at t1 was found. Conclusion: This study demonstrated the onset of Incobotulinumtoxin A efficacy started after 7 days; this rapid action and efficacy of BoNT/A preparation could improve an intensive rehabilitation program after some days post-injection. Early clinical onset of action could be by the absence of complexing proteins in the preparation.

Background and Objective:Spasticity (most common disability in upper motor neuron syndrome or UMNS) caused an inability of patients’ to perform daily activities and a decrease inquality of life. One of the promising methods nowadays, but still not widely used in everyday practice, for spasticity reduction is extracorporeal shock wave. The aim of this study was to evaluate the objective clinical effects of combined treatment botulinum toxin type A and radial Extracorporeal Shock Wave Therapy in spasticity post stroke.Methods:We considered 30 subjects (14 female and 16 male) with post stroke spasticity of Biceps Brachii, Superficial Flexor Digitorum, Gastrocnemius Medialis and Lateralis and we divided patients into two groups (group A received botulinum toxin injection and physiotherapy while group B received botulinum toxin injection, rESWT and physiotherapy). Assessments were performed before treatment (t0), after 1 (t1), 2 (t2) e 3 (t3) months using Modified Ahworth Scale, Visual Analogical Scale for pain and MyotonPro® device (to assessed myometric evaluation of muscles tone and stiffness).Results:Visual Analogical Scale, Modified Ahworth Scale, muscles tone and stiffness statistically decreased until t3 in the group A and in the group B, but the differences between the two groups were significant at the t1 only.Conclusion:Radial Extracorporeal Shock Wave Therapy could be an effective physical treatment aimed at the reduction of upper and lower limbs spasticity and could lead to the improvement of trophic conditions of the spastic muscles in post-stroke.

Background and Objective: Ankle sprains, very common injuries occurred especially during sports activities, are mainly caused by indirect trauma, which influences exaggerated stress exceeding the strength of stabilization mechanisms. Up to 85% of such injuries result from a sudden flexion and inversion of the foot. In this study, we analyzed the effectiveness of the platform Pro-kin, an innovative system that has given us the possibility to combine the functionality of the older proprioceptive boards with very accurate software in order to improve and accelerate the recovery after ankle injuries. Methods: 30 patients with moderate ankle sprain outcomes in two groups (A and B) were included in this study. Group A was only treated with proprioceptive exercises for 3 weeks, while the group B was trained with the innovative Pro-kin. In both groups, we evaluated VAS scale, the ratio between the number of circumductions performed by the injured foot and the time spent on doing them and the percentage of load among the injured and the healthy foot in statics and dynamics with electronic baropodometry. Our data has been collected at t0 (beginning of study), t1(one week later), t2 (two weeks later), t3 (one month later), t4 (two months later), and then analyzed by the two-way analysis of variance (2-way ANOVA) test. Results: At t0 no statistical differences of pain in the 2 groups (3.3 and 3.4); the values were similar, as well as at time t1, t2, t3 and t4. Therefore we deduce that Pro-kin treatment is not painful. The number of circumductions performed was definitely better in B group since the first week; for the A group the values considerably increased only at t3 (one month later). Comparing the load percentages on two feet detected by the electronic baropodometer in statics and in dynamics, we deduced that the patients of A group tend to lean mostly on the healthy foot than B group. Conclusions: This study demonstrates that new technological resources (such as Pro-kin) may be helpful to improve and speed up the recovery of ankle sprain in athletes.

Background and Objective: Carpal tunnel syndrome (CTS) is the most common form of nerve entrapment. Clinically, various signs and symptoms compare due to overexposure to mechanical vibrations transmitted to the wrist bones and cartilage, resulting in compression of the sensory and motor nerve fibers of the median nerve. Early symptoms include nocturnal paresthesia and electromyography reveals reduced sensory nerve conduction velocity. Aim of this study was to evaluate the efficacy of a dietary integrator composed of acetyl-L-carnitine, α-lipoic acid, quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins in patients with early (minimal) carpal tunnel syndrome. Methods: 36 patients (28 female and 8 male) with early CTS characterized by sensory nerve demyelination and inflammation of the transverse carpal ligament. Patients were divided into two groups, group A (18 patients received physical therapy) and group B (18 patients received physical therapy and an oral integrator). Clinical (sleep quality questionnaire to measure severity of paresthesia) and neurophysiological assessment (Sensory Nerve Conduction Velocity) performed at baseline, and then at 30 and 60 days after treatment. Results: Sleep quality and Sensory Nerve Conduction Velocity data analysis show improvement in both groups at 30 and 60 days, with statistical difference between them in both time of analysis. Conclusions: In the early CTS, with sensory fibers damage, use of dietary integrator, such as Micronil Dol®, composed of acetyl-L-carnitine, α-lipoic acid, quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins can be effective in quick recovery of median nerve sensory.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease (unknown pathogenesis) of the central nervous system that causes death within 1&ndash, 5 years. Clinically, flabby paralysis, areflexia, muscular atrophy, and muscle fasciculations, signs of II motor neuron damage, appear. Sometimes, clinical manifestations of damage of the I motor neuron come out in lower limbs, spastic paralysis, iperflexia, and clonus emerge, and they impair deambulation and management of activities of daily living, such as personal hygiene or dressing. Thus, the first therapeutic approach in these patients involves antispasmodic drugs orally followed by botulinum toxin type A injection (BTX-A). In this study, we study the efficacy of BTX-A and physiotherapy in lower limb spasticity due to ALS and no response to treatment with oral antispastic drugs. We evaluated 15 patients (10 male and five female), with a mean age of 48.06 &plusmn, 5.2 with spasticity of adductor magnus (AM), at baseline (T0, before BTX-A treatment) and in the following three follow-up visits (T1 30 days, T2 60 days, and T3 90 days after infiltration). We evaluated myometric measure of muscle tone, the Modified Ashworth Scale of AM, Barthel Index, Adductor Tone Rating Scale, and Hygiene Score. The study was conducted between November 2018 and April 2019. We treated AM with incobotulinum toxin type A (Xeomin&reg, Merz). Spasticity (myometric measurement, Adductor Tone Rating Scale, and Modified Ashworth Scale) and clinical (Barthel Index and Hygiene Score) improvements were obtained for 90 days after injection (p &lt, 0.05). Our study shows the possibility of using BTX-A in the treatment of spasticity in patients with ALS and no response to oral antispastic drugs, with no side effects. The limitation of the study is the small number of patients and the limited time of observation, therefore, it is important to increase both the number of patients and the observation time in future studies.

We have applied the Random Matrix Theory in order to examine the validity of the NPT treatment in HSP. We have investigated the pathology examining the sEMG recorded signal for about eight minutes. We have performed standard electromyographic investigations as well as we have applied the RMT method of analysis. We have investigated the sEMG signals before and after the NPT treatment. The application of a so robust method as the RMT evidences that the NPT treatment was able to induce a net improvement of the disease respect to the pathological status before NPT.

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.

This paper discusses a case of muscular dystrophy on which it has been performed HRV analysis. The results that we obtain evidence that the subject delineates a net ANS dysfunction. All the basic parameters relating standard time and frequency domain of HRV analysis result profoundly altered. Examination by Poicare plot evidences in particular that the subject has an atrial fibrillation. Non linear indexes ApEn and Samp En evidence the very high condition of risk of the subject. The merging indication is for the cardiologist and scholars in cardiovascular disease to perform always ANS investigation in subjects in case of muscular dystrophy. After the NPT treatment, the subject obtains a net improvement.

This is a study on autonomic neuroscience. In a previous paper in [1], we studied a subject affected from facioscapulohumeral muscular dystrophy before and after Ken Ware treatment (NPT). Using the non linear methodology of the Generalized Mutual Information (GMI) analysis of Sensory Motor Rhythm, we produced detailed results evidencing that the mentioned NPT treatment involved a net improvement of the patient under his subjective psychological condition, and in particular, under the neurological and sensory motor profile. We quantified with accuracy the improvement that the subject realized during such treatment. Of course, previous studies of several authors have evidenced that muscular dystrophies are strongly linked to a profound ANS disfunction.Therefore, the aim of the present study was to analyze the ANS of the subject before and after the treatment. We performed analysis in time as well as in frequency domain and by using non linear methods. The basic result of the paper was that, according to our analysis, the subjects started with a serious ANS disfunction before the NPT treatment and that a net improvement was obtained after this therapy. All the examined parameters resulted strongly altered before the treatment and all they returned in the normal range after the NPT.

We perform an analysis of brain-neuromuscular synchronization and coupling strength in muscular dystrophy before and after NPT treatment. In order to estimate with accuracy the level of brain synchronization, we introduce and use the method of the cross GMI that was elaborated by Pompe. The finality is to account for the nonlinear chaotic dynamic contributions that regulate the dynamics. We find that this method is excellent and it may be applied in such case of sEMG and EEG study as well as at a general neurological level. By it we arrive to quantify the coupling strength and synchronization first between two muscular sections (left and right trapezes) and after between Brain activity, as recorded by the EEG, and the trapezes. We compare the results before and after the NPT treatment and we find that the improvement obtained following such treatment is very consistent. We have now in progress other studies relating in particular the application of such new methodologies to other more serious pathologies as the HSP (Hereditary Spastic Paraplegia).

Background and objective Goldenhar syndrome (ocular-auricular-vertebral syndrome), a rare congenital condition arising from defects in the first and second brachial arches, consists in clinical variety of features ranging from facial abnormalities, ear-eye abnormalities, vertebral defects and congenital heart problems and severe obstructive sleep apnea. Due to craniofacial abnormalities, patients presents mechanical obstructive phenomena and sialorrhea that cause prone position, language's fastening, use of nasopharyngeal cannulas and tracheal intubation. Methods In this article, we report a case of a 16 years old child affected by Goldenhar syndrome and sialorrhea to demonstrate improvement of the daily patient management, through inoculations of botulinum toxin type A. Due to severe sialorrhea which caused tracheobronchial daily aspirations, the caregivers used an external aspirators. Results In the first infiltration (August 2016) the parotid and submandibular glands bilaterally were inoculated with incobotulinum toxin type A (Xeomin®, Merz Pharma) with dosages of 5 UI for each of them, for a total of 20 UI without clinical efficacy (no quantitative and qualitative saliva reducing during 3 months). In the second (November 2016) and third (February 2017) infiltrations each parotid and each submandibular glands were injected with a (dosage of 7 UI and 5 UI respectively (total of 24 UI of incobotulinumtoxin A) with important clinical results (saliva production and tracheo-bronchial aspirations reduced). Conclusion Therefore, botulinum toxin type A could be a good and non invasive treatment of sialorrhea in Goldenhar syndrome to improve oral hygiene and daily patient management.

The aim of this trial was to evaluate the effects of α-lipoic acid (ALA) and γ-linolenic acid (GLA) and the beneficial effect of physical exercise on positive sensory symptoms and neuropathic pain in patients with compressive radiculopathy syndrome from disc-nerve root conflict. Often these painful syndromes after the acute event, tend to recurrence becoming subacute or chronic syndromes that become for the period of interest disabiling is an event very important in these cases proper prevention, based on a maintenance drug therapy and the strengthening exercises of paravertebral muscles, flexibility exercises on the spine and when needed on the reduction of body weight. In this Observational Cohort, two-arm trial, 203 patients were enrolled and divided into two groups, the first, “ALA and GLA group”, (n = 101) received oral dose of 600 mg of α-lipoic acid (ALA) and 360 mg of γ-linolenic acid (GLA) and a rehabilitation program for six weeks, the second (n = 102) treated with only rehabilitation program. Patients were recruited at the centre of Physical Medicine and Rehabilitation, have undergone a physiatric examination at the primary outcome (t0) and secondary outcomes were recorded at monitoring visits scheduled at two weeks = t1, four weeks = t2, six weeks = t3, and at the same has been administered the following scale: VAS scale, SF-36, Oswestry Low Back Pain Disability Questionnaire, Aberdeen Back Pain Scale (ABPS), Revised Leeds Disability Questionnaire (LDQ), Roland and Morris Disability Questionnaire. Significant improvements has been noted in the “ALA and GLA group” for paresthesia, stabbing and burning pain, as showed by VAS (Visual Analogue Scale), Oswestry Low Back Pain Disability Questionnaire, Aberdeen Low Back Pain Scale; also, improvements of “quality of life” has been noted, in the same group, as showed by SF-36, LDQ (Revised Leeds Disability Questionnaire), Roland and Morris disability questionnaire. These all outcome measure showed decreases statistically significant. Oral treatment with α-lipoic acid (ALA) and γ-linolenic acid (GLA) for six weeks in synergy with rehabilitation therapy improved neuropathic symptoms and deficits in patients with radicular neuropathy.

Onset of action, duration and maximum efficacy of different botulinum toxin type A (BoNT/A) preparations have been compared mainly in in vitro studies. This single-center open study compared onset of action of the two BoNT/A preparations onabotulinumtoxinA (complex size 900 kDa) and incobotulinumtoxinA (free of complexing proteins, 150 kDa) in patients with spasticity after cerebral stroke over a 15-day treatment period. Outcome measures were changes in muscle tone, increase in passive extension of the elbow, changes in limb functionality, and variation of the amplitude of the compound muscle action potential (cMAP) determined by electroneurography. A total of 108 patients (mean age 64.8 ± 11.3 years) were included in the study, 54 in each treatment arm. Muscle tone, elbow motion range, and limb function significantly improved in both groups from baseline to day 15 after BoNT/A injection (p

Fibromyalgia (FM), clinical condition characterized by several signs and symptoms such as widespread pain, trigger point, morning stiffness and extreme tiredness for scarce hours of sleep, is linked to several changes in several brain neurotransmitters, particularly serotonin and norepinephrine. Consequently, the Neural Vegetative System works more and so it generates an exaggerated muscular contraction, sweating and constriction of blood vessels. The aim of our study was to treat a selected group of female patients suffering from FM with duloxetine with physiotherapy. We used two clinical scales (VAS and FIQ) and an objective evaluation such as myometric. The analysis of the data Myoton used during any inspection showed a statistically significant reduction in the values of muscle tone in each district analyzed. This finding was also confirmed by the patients themselves who have experienced a significant welfare and less muscle tension in different locations, as evidenced by data obtained from the clinical scales used by us. In addition, our patients were thought to be satisfied with the improvements not only subjective, but also with the objective witnessed myometry, making them a share of the study and feeling constantly monitored for treatment aimed at a real reduction in muscle stiffness. In conclusion, our study demonstrates combined treatment duloxetine- physiotherapy effectively reduces a symptom often disabling and particularly troublesome in patients with FM as the exaggerated muscle contraction.

Spasticity is a motor disorder with an increased muscle tone, typically associated with spasms, weakness and lack of coordination. It is an invalidating and debilitating pathology, characterized by pain, limited autonomy in activities of daily living, development of severe lesions. Spasticity can be adequately treated with physiotherapy, muscle relaxants drugs or topical treatment with botulinic toxin type A. Intrathecal baclofen therapy is very effective in the treatment of severe and generalized spasticity. Sometimes, soft tissues adjacent to the implant intrathecal infusion become infected; removing intrathecal infusion and systemic antibiotic therapy are best solution for clinical cure. However, removing intrathecal baclofen therapy could increase muscle spasticity with enhancement of pain and clonus that can worsen quality of life. In this study, we evaluated clinical improvement after complete healing of the septic focus and implantation of a new infuser.

Background: The multiple sclerosis is often associated with motor impairment and disorders of gait and balance, which are thought to be the main causes of the worsening of quality of life and functional autonomy. Many people with multiple sclerosis have a higher incidence of falls than healthy people, so that they risk more traumas; the lack of movement related to the motor impairment is therefore enhanced by the fear of falls. Aims: To assess the efficacy of the "Prokin"system, composed of balance board and visual/acoustic feedback, associated with conventional proprioceptive training in increasing static and dynamic balance, proprioception, coordination and functional autonomy in patients with multiple sclerosis and to compare it with conventional physical therapy. Methods: We enrolled 23 patients with defined SM (4 men, 19 women) divided into 2 groups (A and B). Patients of group A (14) underwent 2 series of 10 sessions of 2-a-week proprioceptive training with Prokin system; patients of group B (5) underwent 2 series of 10 sessions of a 3-a-week conventional balance training. Each patient was assessed at t0 (before training), t1 (after 10 sessions) and t2 (after 20 sessions) with clinical scales for balance control (Tinetti, Berg) and autonomy (Barthel), and with instrumental tests (stabilometry, analyzing sway area, length of track and sway speed; and proprioceptive multiaxial assessment, exploring the Average Track Error). Results: In group A we found statistically significant (p

Cervical dystonia is a syndrome characterized by anomalous postures and unintentional repetitive movements of the head and the neck. Aim of this study is to show the effectiveness of the combined treatment botulinum toxin-FKT through the use of a recent methodic of investigation, myoton, and of the classical clinical evaluations, such as Tsui and VAS scales. 15 patients (9 females, 6 males) have been selected. During the initial visit and in the following controls, performed every month, patients have been submitted to physiatric examination, clinical evaluation of the dystonia through the Tsui scale, clinical evaluation of the pain through the VAS scale, myometric evaluation. We obtained a statistical reduction of muscular tone values in passive elongation (t0=16,34#x00B1;1,23) until 4 month (t4 =16,11#x00B1;1,23), when we performed a second infiltration. After 4 months from the second infiltration (t8=15,99#x00B1;1,11) value did not present more some statistical correlation and was necessary to perform a new infiltration. Values of elasticity, stiffness, Tsui and VAS scale followed the same course of the tone. Our study demonstrates that combined treatment botulinum toxin-FKT is effective. It emerges that if to the treatment with botulinum toxin follows a suitable FKT treatment, the effect of the drug lasts 4 months and not 3 months as described by the literature. Our study has underlined that using myometric measurement we can consider least changes in muscular tone, elasticity and stiffness; we have a broader view of the spastic muscle, and we can better plan appropriate rehabilitative care for each patient.