Archive for category spasticity

[Abstract] Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation


The paper suggests a therapeutic device for hemiparesis that combines robot-assisted rehabilitation and mirror therapy. The robot, which consists of a motor, a position sensor, and a torque sensor, is provided not only to the paralyzed wrist, but also to the unaffected wrist to induce a symmetric movement between the joints. As a user rotates his healthy wrist to the direction of either flexion or extension, the motor on the damaged side rotates and reflects the motion of the normal side to the symmetric angular position. To verify performance of the device, five stroke patients joined a clinical experiment to practice a 10-minute mirroring exercise. Subjects on Brunnstrom stage 3 had shown relatively high repulsive torques due to severe spasticity toward their neutral wrist positions with a maximum magnitude of 0.300kgfm, which was reduced to 0.161kgfm after the exercise. Subjects on stage 5 practiced active bilateral exercises using both wrists with a small repulsive torque of 0.052kgfm only at the extreme extensional angle. The range of motion of affected wrist increased as a result of decrease in spasticity. The therapeutic device not only guided a voluntary exercise to loose spasticity and increase ROM of affected wrist, but also helped distinguish patients with different Brunnstrom stages according to the size of repulsive torque and phase difference between the torque and the wrist position.

Source: Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation – IEEE Conference Publication


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[ARTICLE] A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity – Full Text


Introduction Stroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity. The neurophysiological assessment of the stretch reflex provides a precise and objective method to measure spasticity. We propose a novel study to understand if Sativex could be useful in reducing spasticity in stroke survivors and investigating tolerability and safety by accurate cardiovascular monitoring.

Methods and analysis We will recruit 50 patients with spasticity following stroke to take THC:CBD in a double-blind placebo-controlled cross-over study. Spasticity will be assessed with a numeric rating scale for spasticity, the modified Ashworth scale and with the electromyographical recording of the stretch reflex. The cardiovascular risk will be assessed prior to inclusion. Blood pressure, heart rate, number of daily spasms, bladder function, sleep disruption and adverse events will be monitored throughout the study. A mixed-model analysis of variance will be used to compare the stretch reflex amplitude between the time points; semiquantitative measures will be compared using the Mann-Whitney test (THC:CBD vs placebo) and Wilcoxon test (baseline vs treatment).


Stroke is one of the most disabling neurological disease and frequently determines important chronic consequences such as spasticity. Prevalence of poststroke spasticity ranges from 4% to 42.6%, with the prevalence of disabling spasticity ranging from 2% to 13%.1 Treatment of poststroke spasticity is based on rehabilitation, local injection of botulinum toxin (BoNT) in the affected muscles for focal spasticity and/or use of classic oral drugs such as tizanidine, baclofen, thiocolchicoside and benzodiazepines, which are not always effective and have a good number of possible side effects.

The transmucosal administration of delta-9-tetrahydrocannabinol and cannabidiol (THC and CBD at 1:1 ratio oromucosal spray, Sativex) is able to reduce spasticity acting on endocannabinoid receptors CB1and CB2. This novel drug has been licensed after an extensive clinical trial programme2–4 in adult patients with multiple sclerosis who have shown no significant benefit from other antispasmodic drugs. More than 45 000 patient/years of exposure since its approval in more than 15 EU countries support their antispasticity effectiveness and safety profile in this indication.5 Besides improving spasticity, cannabinoids can be beneficial in reducing pain, chemotherapy-induced nausea and vomiting; moreover, they contribute to reducing seizures and to lowering eye pressure in glaucoma.6Cannabinoids can also exert psychological effects by lowering anxiety levels and inducing sedation or euphoria. Marijuana, which is the main source of cannabinoids, is declared illegal in many countries mostly because of the risk of abuse, dependence and withdrawal syndrome, related to the effect of its high amounts of THC. Several reports support an increased ischaemic stroke risk related to relevant abuse of smoked marijuana7–17 as well as synthetic cannabinoids.18–20 Ischaemic stroke following cannabis involves more frequently basal ganglia and cerebellum where CB1 and CB2 receptors show a higher expression.13

The ‘French Association of the Regional Abuse and Dependence Monitoring Centres Working Group on Cannabis Complications’ warns about the increased cardiovascular risk related to the use of herbal cannabis, mostly consisting of acute coronary syndromes and peripheral arteriopathies, potentially leading to life-threatening conditions.21 The detrimental consequences of cannabinoids could be attributed to the increase in heart rate22 as well as arterial spasms also in the context of a reversible cerebral vasoconstriction syndrome,23 but also vasculitis, postural hypotension and cardioembolism.24

On the other side, some studies support a beneficial effect on stroke evolution of cannabinoid receptors stimulation. In fact, cannabinoid-mediated activation of CB1 and CB2 receptors reduces inflammation and neuronal injury in acute ischaemic stroke.25 Activation of CB2 receptors shows protective effects after ischaemic injury26 and inhibits atherosclerotic plaque progression.27 28

To our knowledge, no correlations have been reported between haemorrhagic stroke and cannabinoids intake. In our opinion, the modification of blood pressure is the most important cannabinoid effect that should be taken into account in patients with a previous haemorrhagic stroke or predisposed to intracranial bleeding. Cannabinoids are indeed capable of inducing blood pressure fluctuations in a specific triphasic pattern (low-high-low) potentially harmful if the patient is with bleeding risk.29Ischaemic disease is not included among THC:CBD oromucosal spray contraindications. However, considering that, to our knowledge, no study has been performed with THC:CBD oromucosal spray on post-stroke spasticity, we believe that a particular caution should be used in stroke patients.

The decision of which method of measure is considered as end point is a major issue in studies involving spasticity. The definition of spasticity provided by Lance is one of the most precise and reliable, focusing on the stretch reflex as the neurophysiological equivalent of spasticity.30 Probably because of technical complexity and required expertise, neurophysiological approaches are rarely adopted. Clinical rating scales such as the modified Ashworth scale (MAS)31 or subjective scores such as the numeric rating scale (NRS) for spasticity are being widely used.32 33 Recent evidence supports the idea that MAS and NRS are indeed useful to quickly rate spasticity in a clinical setting, however NRS provide a very variable and imprecise assessment of many symptoms related to spasticity, but where spasticity itself is probably only a common factor.34 The adoption of stretch reflex as the most appropriate neurophysiological measure of spasticity increases the specificity and reduces the variability of the end point and is particularly suitable for clinical trials.

Our proposal is therefore to assess the efficacy of THC:CBD oromucosal spray in patients with spasticity following stroke as add-on to first-line antispasticity medications with an experimental pilot randomised placebo-controlled cross-over clinical trial using the stretch reflex as primary outcome measure. Prior to inclusion in the study, we propose strict selection criteria in order to reduce the risk of relevant side effects. […]

Continue —>  A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity | BMJ Open


Graphical representation of the study protocol, particularly depicting the cross-over design and the time points. THC/CBD, tetrahydrocannabinol/cannabidiol.

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Objective: To evaluate the influence of transcutaneous electrical nerve stimulation in patients with stroke through a systematic review and meta-analysis.

Methods: PubMed, Embase, Web of Science, EBSCO, and Cochrane Library databases were searched systematically. Randomized controlled trials assessing the effect of transcutaneous electrical nerve stimulation vs placebo transcutaneous electrical nerve stimulation on stroke were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome was modified Ashworth scale (MAS). Meta-analysis was performed using the random-effect model.

Results: Seven randomized controlled trials were included in the meta-analysis. Compared with placebo transcutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation supplementation significantly reduced MAS (standard mean difference (SMD) = –0.71; 95% confidence interval (95% CI) = –1.11 to –0.30; p =0.0006), improved static balance with open eyes (SMD = –1.26; 95% CI = –1.83
to –0.69; p<0.0001) and closed eyes (SMD = –1.74; 95% CI = –2.36 to –1.12; p < 0.00001), and increased walking speed (SMD = 0.44; 95% CI = 0.05 to 0.84; p = 0.03), but did not improve results on the Timed Up and Go Test (SMD = –0.60; 95% CI=–1.22 to 0.03; p = 0.06).

Conclusion: Transcutaneous electrical nerve stimulation is associated with significantly reduced spasticity, increased static balance and walking speed, but has no influence on dynamic balance.

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[ARTICLE] Botulinum toxin type-A overdose for the treatment of spastic muscles in two patients with brain injuries – Full Text


Spasticity is commonly encountered clinically, and always affects patients’ motor ability and capacity for self-care which necessitates intervention. At present, numerous methods have been proposed with varying effects. Many reports show that the most effective method is to inject botulinum toxin, type A (BTX-A) into the spasming muscles, but the doses are different. The guidline of BTX-A injection in Chinese adults is restricted to 600 IU each time within 3 months. In this article, we treated two brain injury patients with severe regional spasticity with overdose of China-making BTX-A whose trademark is HengLi. The treatment improved spasticity and with little adverse effects. We therefore conclude that overdoses of BTX-A could also be safe and more efficient used in some patients who are showing severe spasticity of limb muscles, but it should be vary with each individual and a large sample size trial is needed for a further confirmation.


Spasticity often occurs after brain injury and always affects the motor ability and other function of the patient, thereby necessitating intervention in some cases. At present, the most effective method is injection of BTX-A in the spasming muscles. However, there is no unified guideline for the injection doses [1], the highest dosage for a single injection is less than 600 IU in Chinese guideline. So the most usage dose of BTX-A which injected to the spastic muscles of patient, was always 100-500 IU per time of per patient in our clinical work days, and sometimes it seems to take insufficient effects during a period of 2 weeks, the effect of BTA-A even last for more than 3 months.

So in patients with extensive or severe muscle spasm we decided to increase the dose of BTX-A. Although the halflethal dose of BTX-A is 40 IU/kg of body weight, which implies that a dose of BTX-A over 600 IU is safe, even a larger dose might be safe enough, but it is not confirmed yet, only few trials of small sample has been published, and the doses are less than that we used [2]. Thus, we tried administering higher BTX-A doses in two patients who had developed a severe regional spasticity after brain injury. To our knowledge, none of this kind of reports has been published yet.

Case Presentation

This study was conducted in accordance with the declaration of Helsinki, and it was conducted with approval from the Ethics Committee of the affiliated hospital of Qingdao University. Written informed consents were obtained from the participants. All procedures were performed with the consent of the patients and their family members.

Case 1

A 57-year-old man was admitted because of sudden glossolalia with choking and coughing while drinking, who was also unable to walk and swallow, had an over 10 years history of high blood pressure, but irregular use of antihypertensive agents. He was carried to our hospital for further rehabilitation after a preliminary treatment in a local hospital. Physical examination (PE) at admittance: BP 148/86 mmHg. The systolic pressure was a little higher, and his heart rate, rhythm and both the lungs were heard normal.

Nervous system examination (NSE): Although consciously, but the patient was anepia, depressed, and a little uncooperative on checking. His right nasolabial groove was relatively shallower, and poor tongue controlling. 0-1 grade muscle strength on his right side, and 3-4 grade on the left, increased muscle tone, and hyperactive tendon reflex, Modified Ashworth Scales (MAS) of both sides are range from 1+ to 2 grade. Right Babinski’s sign was positive (+), but the left was doubtful positive (±). Thus the patient was diagnosed as brain stem infarction. He was treated by kinesitherapy (occupational and physical training), and swallowing disorder treatment. After 2 weeks of rehabilitation, his sitting balance reached grade 2; He could stand up from bed with one person’s assistance, but could not take a step. He experienced difficulty in lifting his feet and obvious spasticity of his right limbs. His MAS for left elbow flexion muscle, right hamstring, and right triceps surae was grade 2, whereas his left triceps surae was grade 1+. After taking Tizanidine (an oral antispasmodic drug) for about one month, with the dose gradually increasing from 6 mg/d to 12 mg/d. However, there was appeared some unexpected symptoms, such as dizziness and/or sleepiness [3].

Thus we decided to administer a local injection of megadose of BTX-A in the severe spasming limb muscles. The right upper flexor muscles and the right lower limb were injected with 250 IU and 450 IU, respectively. We chose 5 muscles as the targets for injection:

  1. The adduction muscle
  2. Hamstring muscles

  3. Triceps surae

  4. Posterior tibial muscle

  5. And/or flexor digitorum longus

We used surface electrodes to detect the most contracted and sensitive parts of the muscles, marked on the surface then inserted needle electrodes deeply into the muscle to search for the appropriate motor points. Drug preparation: 100 U BTX-A was diluted with 2 ml normal saline to a final concentration of 50 U/ml. 4-6 injection points for a large muscle and 1-2 for small muscles were selected; each point injected 0.5-1 ml (25-50 U) BTX-A. After 4-10 days, the tone of the injected muscles was decreased, and gradually the patient could also stand and take steps in a stable condition. Two weeks to 3 months after injection both the patient’s Modified Ashworth Scale (MAS) and independent functional walking ability improved significantly, except a short period of mild weakness of muscle strength, there is no adverse effect occurred.

Cases 2

A 48-year old male was admitted to ICU 2 months after multiple traumatic injuries during a traffic accident. PE: Clearminded and spoke fluently, but high-level intelligence was impaired, especially the memory and orientation ability, and both of his eyes had limited abduction, hypopsia of counting fingers at a 60 cm distance. The muscle forces for both the upper limbs were grade 4 (MMT), moving with slight fibrillation. The proximal muscle force of the left leg was grade 2, whereas the distal level was 0. The right lower limb proximal muscle force was grade 1 and the distal was grade 0, with increased muscle tone of MAS grade, for the bilateral quadriceps were level 3, and the bilateral adductors were level 2-3. Magnetic resonance imaging (MRI) showed changes after the traumatic brain injury, including hydrocephalus. Thus the final diagnosis of the patient was “Brain injury, Multiple fractured ribs, Left femur fracture, and Acute suppurative myelitis”.

After routine rehabilitation therapy for 3 months, the patient’s sitting balance was restored to level 2. He could stand up and sit down with assistance. He could stand but could not move with walking aid. The bilateral iliopsoas muscle forces were 2-3 level. He could walk 3-5 meters on flat ground with the use of bandages and support from two persons. His hips showed obvious bilateral adduction leading to an atypical scissors gait, which made knee flexion and sitting difficult. He was given a little dose of Tizanidine firstly, however, Tizanidine administration was rapidly terminated because of its adverse effects, such as lethargy, low blood pressure [3]. BTX-A injection was then administered to his bilateral adductor muscles and quadriceps femoris at a final dose of 350 U each. The dilution and injection methods were the same as those described in Case 1. After 3-7 days of injection, we evaluated the patients’ lower limb muscles spasm degree [4]. The MAS was improved significantly, and the grade of functional walking ability improved at 2 and 4 weeks respectively after the injection, lasting more than 3 months.


BTX-A has been used to treat muscle tension disease for more than 50 years, and it has been widely applied by now [510]. At present, BTX-A can be made in several countries including China. The commercial name of Chinese BTX-A is HengLi, each vial contents 100 U. BTX blocks the physiological function of cholinergic nerve conduction, especially at the muscle-nerve joints, thus causing voluntary muscle relaxation. BTX-A is one of the most toxic substances in the world. However, after nearly 50 years of clinical application, the safety of BTX-A has been fully demonstrated [11]. A halflethal dose of mankind is 40 IU/kg, but with a maximum permissible dose of 600 U being the Chinese domestic expert consensus in 2010. As a result, repeated injections may cause immune complex diseases, so repeated BTX-A injection within 3 months is prohibited, but repeated injections have been reported in a short term within 1 week. Repeated injection in a short term is not well understood, and therefore, we do not advocate this approach.

We report two cases with muscle spasms after brain injury, who were treated by injecting BTX-A. Both the injection doses exceed the maximum dose of the Expert Consensus but were far from the median lethal dose. In both cases, no adverse reactions occurred, and the treatment helped achieving better clinical effects than the alternatives, similar to that reported in previous studies [1214]. Overdosage of BTX-A can be more efficacy and safe enough, therefore, in our further clinical study, according to the individual need and economic characteristics of the patient, we should reasonably and individually adjust the doses of BTX-A to achieve the best therapeutic effect and more beneficial to the patients’ self-care ability.


Source: Botulinum toxin type-A overdose for the treatment of spastic muscles in two patients with brain injuries

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[Abstract] Effect of Close Kinematic Chain Exercises on Upper Limb Spasticity in Hemiparetic Adult


Background: As upper limb spasticity is the major hindrance in quality of life in hemiparesis, this project emphasizes on the effect of close kinematic chain exercises on upper limb spasticity. So, the present study was conducted to find out the effect combined effect of conventional exercises with close kinematic chain exercises on spasticity.

Method: Comparative study was conducted at Krishna College of Physiotherapy, Karad.20 subjects with age group between 40–60 years were taken. Participants of Group A (10) were treated with close kinematic chain exercises along with conventional treatment & GroupB(10)only with conventional treatment. Exclusion criteria of the study was: 1. Associated psychological disorder. 2. Perceptual disorders. 3. Any visual & auditory impairment. 4. Any orthopaedic disorder.

Results: Statistical analysis was done using paired, unpaired ”t’’test, Mann Whitney test and Friedman statistics. The results showed statistically significant reduction in spasticity in group A as compared to group B (p<0.001).

Conclusion: The study shows that close kinematic chain exercises helps in normalizing tone, reducing spasticity in upper extremity hemiparesis.

Source: Indian Journals

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[Abstract] Case Report on the Use of a Custom Myoelectric Elbow–Wrist–Hand Orthosis for the Remediation of Upper Extremity Paresis and Loss of Function in Chronic Stroke.


Introduction: This case study describes the application of a commercially available, custom myoelectric elbow–wrist–hand orthosis (MEWHO), on a veteran diagnosed with chronic stroke with residual left hemiparesis. The MEWHO provides powered active assistance for elbow flexion/extension and 3 jaw chuck grip. It is a noninvasive orthosis that is driven by the user’s electromyographic signal. Experience with the MEWHO and associated outcomes are reported.

Materials and Methods: The participant completed 21 outpatient occupational therapy sessions that incorporated the use of a custom MEWHO without grasp capability into traditional occupational therapy interventions. He then upgraded to an advanced version of that MEWHO that incorporated grasp capability and completed an additional 14 sessions. Range of motion, strength, spasticity (Modified Ashworth Scale [MAS]), the Box and Blocks test, the Fugl–Meyer assessment and observation of functional tasks were used to track progress. The participant also completed a home log and a manufacturers’ survey to track usage and user satisfaction over a 6-month period.

Results: Active left upper extremity range of motion and strength increased significantly (both with and without the MEWHO) and tone decreased, demonstrating both a training and an assistive effect. The participant also demonstrated an improved ability to incorporate his affected extremity (with the MEWHO) into a wide variety of bilateral, gross motor activities of daily living such as carrying a laundry basket, lifting heavy objects (e.g. a chair), using a tape measure, meal preparation, and opening doors.

Conclusion: Custom myoelectric orthoses offer an exciting opportunity for individuals diagnosed with a variety of neurological conditions to make advancements toward their recovery and independence, and warrant further research into their training effects as well as their use as assistive devices.

Source: EBSCOhost | 123998452 | Case Report on the Use of a Custom Myoelectric Elbow–Wrist–Hand Orthosis for the Remediation of Upper Extremity Paresis and Loss of Function in Chronic Stroke.

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[ARTICLE] Dose-Dependent Effects of Abobotulinumtoxina (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study – Full Text



AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited.


To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS.


Secondary analysis of a phase 3 study (NCT01313299).


Multicenter, international, double-blind, placebo-controlled clinical trial.


A total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose).


The overall effect of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects.

Main Outcome Measures

Angle of arrest (XV1) and angle of catch (XV3) were assessed with the Tardieu scale, and active range of motion (XA).


At each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (XV1, XV3, XA) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in XV3 and XA, suggesting a dose-dependent effect.


Previous clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints.


Upper limb spasticity (ULS) is a common symptom after stroke and traumatic brain injury (TBI) and is associated with impaired self-care and additional burden of care [1-5]. Among several treatment strategies, guidelines recommend intramuscular botulinum toxin injections as a first-line treatment for adults with ULS [6-11].

Botulinum toxin type A (BoNT-A) injections may target upper extremity muscle groups from the shoulder, to decrease adductor and internal rotation tone, to the elbow, wrist, fingers, and thumb, to decrease flexor tone [12,13]. Specific muscle selection is based on the pattern of muscle overactivity, functional deficits, and patient goals [6]. These goals include increased passive and active range of motion, improved function (feeding and dressing), easier care (palmar and axillary hygiene), and reduction of pain [13].

Evidence-based information on optimal dosing for clinical use is relatively sparse. Dosing is not interchangeable between different BoNT-A products; therefore, improving our understanding of product-specific dosing will minimize confusion among injectors and improve the quality of patient care [13].

Among BoNT-A formulations, abobotulinumtoxinA (Dysport; Galderma Laboratories, LP, Fort Worth, TX) has been shown to decrease muscle tone (as measured by the Modified Ashworth Scale [MAS]) [13-17] and pain [18] and to facilitate goal attainment [19] in adults with ULS. A recent systematic review [13] of 12 randomized controlled trials (RCTs) in ULS concluded that abobotulinumtoxinA (total dose range, 500-1500 U) was generally well-tolerated, with “strong evidence” to support reduced muscle tone.

This paper presents the results of a secondary analysis from a recently published large international clinical trial, demonstrating improved active range of motion after abobotulinumtoxinA treatment in adults with hemiparesis and ULS >6 months after stroke or TBI [20]. This phase 3, randomized, double-blind, placebo-controlled study demonstrated that a total dose of either 500 U or 1000 U abobotulinumtoxinA injected in the upper extremity also resulted in decreased muscle tone and improvements in global physician-assessed clinical benefit compared with placebo.

Apart from a systematic measurement of active range of motion (XA) against finger, wrist, and elbow flexors, another unique aspect of the trial was the assessment of spasticity at the finger, wrist, and elbow flexor groups with the Tardieu scale (TS) [21,22]. The TS is a standardized evaluation used to assess the angle of arrest at slow speed (ie, passive range of motion, XV1) and the angle of catch at fast speed (XV3). The trial demonstrated improvements for finger, wrist, and elbow joints at week 4 in XV3 at both abobotulinumtoxinA doses and in XA at 1000 U; for the 500-U dose, improvements in XA were seen in the finger flexors. Both doses were associated with a favorable safety profile [20]. This analysis aims to provide a detailed description of improvements in spasticity and the active range of motion for individual muscle groups by dose and to provide information on muscle-specific dosing, which can be used in future recommendations for injectors.

Continue —> Dose-Dependent Effects of Abobotulinumtoxina (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study – ScienceDirect


Figure 1. Change from baseline of Tardieu scale parameters and of active range of motion week 4 postinjection in (A) extrinsic finger flexors, (B) wrist flexors, and (C) elbow flexors. Dose groups were as follows (lowest to highest dose): 500 U/non-PTMG, 500 U/PTMG, 1000 U/non-PTMG, and 1000 U/PTMG. Standard deviations and mean change from baseline values are detailed in Table 3. PTMG = primary targeted muscle group; XV1 = passive range of motion; XV3 = angle of catch at fast speed; XA = active range of motion.

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Objective: The main aim of this study was to determine
the utilization patterns and effectiveness of onabotulinumtoxinA (Botox®) for treatment of spasticity in clinical practice.

Design: An international, multicentre, prospective, observational study at selected sites in North America, Europe, and Asia.

Patients: Adult patients with newly diagnosed or established focal spasticity, including those who had previously received treatment with onabotulinumtoxinA.

Methods: Patients were treated with onabotulinumtoxinA, approximately every 12 weeks, according to their physician’s usual clinical practice over a period of up to 96 weeks, with a final follow-up interview at 108 weeks. Patient, physician and caregiver data were collected.

Results: Baseline characteristics are reported. Of the 745 patients enrolled by 75 healthcare providers from 54 sites, 474 patients had previously received onabotulinumtoxinA treatment for spasticity. Lower limb spasticity was more common than upper limb spasticity, with stroke the most common underlying aetiology. The Short-Form 12 (SF-12) health survey scores showed that patients’ spasticity had a greater perceived impact on physical rather than mental aspects.

Conclusion: The data collected in this study will guide the development of administration strategies to optimize the effectiveness of onabotulinumtoxinA in the management of spasticity of various underlying

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[Abstract] Efficacy and safety of botulinum toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analysis.



Muscle spasticity is a positive symptom after stroke and traumatic brain injury. Botulinum toxin type A (BoNT-A) injection is widely used for treating post stroke and traumatic brain injury spasticity. This study aimed to evaluate efficacy and safety of BoNT-A for upper limb spasticity after stroke and traumatic brain injury and investigate reliability and conclusiveness of available evidence for BoNT-A intervention.


We searched electronic databases from inception to September 10 of 2016. Randomized controlled trials comparing the effectiveness between BoNT-A and placebo in stroke or traumatic brain injury adults with upper limb spasticity were included. Reliability and conclusiveness of the available evidence were examined with trial sequential analysis.


From 489 citations identified, 22 studies were included, reporting results for 1804 participants. A statistically significant decrease of muscle tone was observed at each time point after BoNT-A injection compared to placebo (SMD at week 4=-0.98, 95% CI: -1.28 to -0.68; I2=66%, P=0.004; SMD at week 6=-0.85, 95% CI: -1.11 to -0.59, I2=1.2%, P=0.409; SMD at week 8=-0.87, 95% CI: -1.15 to -0.6, I2=0%, P=0.713; SMD at week 12=-0.67, 95% CI: -0.88 to -0.46, I2=0%, P=0.896; and SMD over week 12=-0.73, 95% CI: -1.21 to -0.24, I2=63.5%, P=0.065).Trial sequential analysis showed that as of year 2004 sufficient evidence had been accrued to show significant benefit of BoNT-A four weeks after injection over placebo control. BoNT-A treatment also significantly reduced Disability Assessment Scale Score than placebo at 4, 6 and 12-week follow-up period (WMD=-0.33, 95% CI: -0.63 to -0.03, I2=60%, P=0.114; WMD=-0.54, 95% CI: -0.74 to -0.33, I2= 0%, P=0.596 and WMD=-0.3, 95% CI: -0.45 to -0.14, I2=0%, P=0.426 respectively), and significantly increased patients’ global assessment score at week 4 and 6 after injection (SMD=0.56, 95% CI: 0.28 to 0.83; I2=0%, P=0.681 and SMD=1.11, 95% CI: 0.4 to 1.77; I2=72.8%, P=0.025 respectively). No statistical difference was observed in the frequency of adverse events between BoNT-A and placebo group (RR=1.36, 95% CI [0.82, 2.27]; I2=0%, P=0.619).


As compared with placebo, BoNT-A injections have beneficial effects with improved muscle tone and well-tolerated treatment for patients with upper limb spasticity post stroke or traumatic brain injury.

Source: Efficacy and safety of botulinum toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analy… – PubMed – NCBI

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[ARTICLE] Rehabilitation plus OnabotulinumtoxinA Improves Motor Function over OnabotulinumtoxinA Alone in Post-Stroke Upper Limb Spasticity: A Single-Blind, Randomized Trial – Full Text HTML


Background: OnabotulinumtoxinA (BoNT-A) can temporarily decrease spasticity following stroke, but whether there is an associated improvement in upper limb function is less clear. This study measured the benefit of adding weekly rehabilitation to a background of BoNT-A treatments for chronic upper limb spasticity following stroke. Methods: This was a multi-center clinical trial. Thirty-one patients with post-stroke upper limb spasticity were treated with BoNT-A. They were then randomly assigned to 24 weeks of weekly upper limb rehabilitation or no rehabilitation. They were injected up to two times, and followed for 24 weeks. The primary outcome was change in the Fugl–Meyer upper extremity score, which measures motor function, sensation, range of motion, coordination, and speed. Results: The ‘rehab’ group significantly improved on the Fugl–Meyer upper extremity score (Visit 1 = 60, Visit 5 = 67) while the ‘no rehab’ group did not improve (Visit 1 = 59, Visit 5 = 59; p = 0.006). This improvement was largely driven by the upper extremity “movement” subscale, which showed that the ‘rehab’ group was improving (Visit 1 = 33, Visit 5 = 37) while the ‘no rehab’ group remained virtually unchanged (Visit 1 = 34, Visit 5 = 33; p = 0.034). Conclusions: Following injection of BoNT-A, adding a program of rehabilitation improved motor recovery compared to an injected group with no rehabilitation.

1. Introduction

While several blinded and open-label studies have demonstrated the ability of botulinum toxin to temporarily decrease spasticity following stroke, as measured by standard assessments such as the Modified Ashworth Scale [1,2,3,4,5,6,7,8], the ability of botulinum toxin to improve upper limb function following stroke is less clear, with some studies [1,3,4,5,6,7,8], though not all [2,7], reporting functional improvement. Two recent meta-analyses of randomized controlled trials demonstrated that botulinum toxin treatment resulted in a moderate improvement in upper limb function [9,10]. Despite large clinical trials [2,3,11] and FDA approval, the exact timing, use of adjunct rehabilitation, and continuation of lifelong botulinum toxin treatment remains unclear [12,13].
A recent Cochrane Review included three randomized clinical trials for post-stroke spasticity involving 91 participants [14]. It aimed to determine the efficacy of multidisciplinary rehabilitation programs following treatment with botulinum toxin, and found some evidence supporting modified constraint-induced movement therapy and dynamic elbow splinting. There have been varied study designs exploring rehabilitation in persons after the injection of botulinum toxin or a placebo [13,15], rehabilitation in persons after the injection of botulinum toxin or no injection [16], or rehabilitation after the injection of botulinum toxin with no control condition [17]. As the use of botulinum toxin expands and is beneficial in reducing spasticity and costs [18], the benefit of adding upper limb rehabilitation continues to be questioned. We designed this multi-center, randomized, single-blind clinical trial to assess improvement in patient sensory and motor outcome following the injection of onabotulinumtoxinA (BoNT-A), comparing the effects of rehabilitation versus no rehabilitation, using the upper extremity portion of the Fugl–Meyer Assessment of Sensorimotor Recovery After Stroke [19] as the primary outcome measure. While patients could not be blinded to their randomization to receive additional rehabilitation versus no rehabilitation, the assessments of all of the outcome measures were performed by evaluators blinded to rehabilitation assignment in this single-blind design.

2. Results

Thirty-one patients with post-stroke upper limb spasticity were enrolled, with 29 completing the study (Figure 1). The strokes occurred an average of 6 years prior to study entry, with a range of 6 months to 16½ years. The upper extremity postures treated included flexed elbow, pronated forearm, flexed wrist, flexed fingers, and clenched fist, and were evenly distributed between the treatment groups (the initial dose of BoNT-A administered was left up to the clinician’s judgment based on the amount of spasticity present, and did not differ between groups). One participant (‘no rehab’, injected at Visits 1 and 3A) left the study after Visit 3A due to a deterioration in general health and an inability to travel to study visits. A second participant (‘no rehab’, injected at Visits 1 and 3A) left the study after Visit 4 due to a fall with a broken affected wrist. All of the participants were injected at Visit 1, 19 were injected at Visit 3 (8 ‘rehab’; 11 ‘no rehab’), and 7 were injected at Visit 3A (3 ‘rehab’; 4 ‘no rehab’). Those participants who did not receive injections at Visits 3 or 3A had a level of spasticity that either did not meet the injection criteria due to an Ashworth score of <2 in the wrist (and/or fingers) or one that was felt to be too low to warrant injection. Table 1 provides a description of each group with regard to age, sex, race, whether the stroke occurred in the dominant hemisphere, and clinical measures. At baseline, the treatment groups did not differ on any demographic or clinical variables. […]

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