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This article reviews the recent advances or nerve-oriented surgical procedures in the treatment of the spastic upper limb. The idea to intervene on the nerve is not recent, but new trends have developed in nerve surgery over the past few years, stimulating experiments and research. Specific surgical procedures involving the nerves have been described at different levels from proximal to distal: at the cervical spinal cord and the dorsal root entry zone (rhizotomy), at the level of the roots (contralateral C7 transfer) or in the peripheral nerve, within the motor trunk (selective neurectomy) or as its branches penetrate the muscles (hyperselective neurectomy). All of these neurosurgical procedures are only effective on spasticity but do not address the other deformities, such as contractures and motor deficit. Additional procedures may have to be planned in conjunction with nerve procedures to optimize outcomes. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study is to assess the quality, readability, content, accessibility, and structure of online resources for patients with upper limb spasticity. Design: This was a cross sectional study examined Internet searches across three search engines related to patient resources for upper limb spasticity. Search phrases for either hand or upper limb spasticity were used. The top 20 Websites from each search were evaluated using the four readability metrics and the DISCERN scale for quality assessment. YouTube videos with exact search phrases were evaluated using DISCERN. Descriptive statistical analyses were performed using SPSS software. Results: Thirty-six Websites and 33 videos met the inclusion criteria for this study. The average Flesh-Kincaid Grade Level of the Websites was 11.7 ± 3.1, showing low Website readability. According to this index, only two Websites were written at the suggested sixth-grade level (5.4%). With a maximum score of 75, the mean DISCERN score for both Websites and videos scored in the “good” range (53.5 ± 8 and 50.5 ± 6.6), respectively. Conclusions: Current online resources for upper limb spasticity are good in quality but are written above the health literacy level of American citizens. Organizations should consider reviewing their present materials and developing high-quality patient education materials that are easier to understand. [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]

Background and objective: Transcranial magnetic stimulation and peripheral repetitive magnetic stimulation (rPMS), as non-invasive neuromodulation techniques, can promote functional recovery in patients with post-stroke spasticity (PSS), but the effects of transcranial magnetic stimulation combined with peripheral magnetic stimulation on PSS remain largely unknown. Therefore, we examined the effects of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) combined with rPMS on PSS patients and its potential neural correlates to behavioral improvements. Methods: Forty-nine PSS patients were divided randomly into three groups: a combined group (n D 20), a LF-rTMS group (n D 15), and a control group (n D 14). The combined group received LF-rTMS and rPMS treatment, the rTMS group received LF-rTMS treatment, and the control group received only routine rehabilitation. All patients underwent Ashworth Spasm Scale (MAS), upper extremity Fugl-Meyer (FMA-UE), and modified Barthel Index (MBI) assessments before and after intervention. In addition, resting-state functional magnetic resonance imaging data were collected pre- and post-treatment to observe changes in the amplitude of low-frequency fluctuation (ALFF). Results: The MAS score was decreased, FMA-UE score and MBI scores were increased in the three groups after therapy than before therapy (all P < 0.05). In particular, the combined group showed significant effect on improved motor function and relieved spasticity in PSS (P < 0.01). Moreover, the combined treatment increased ALFF values mainly in the right supplementary motor area, right middle frontal gyrus, and right cerebellum, while reduced ALFF values mainly in the right post-central gyrus compared with pre-treatment. Compared with the LF-rTMS and control groups, the combined treatment increased ALFF values in the right cerebellum and reduced ALFF values mainly in the frontoparietal cortex. Improvements in the MAS score were positively correlated with the change in ALFF values in the right cerebellum (r D 0.698, P D 0.001) and the right supplementary motor area (r D 0.700, P D 0.001) after combined treatment. Conclusion: Transcranial combined with peripheral repetitive magnetic stimulation could improve spastic state and motor function in PSS patients, and this effect may be associated with altered cerebellar and frontoparietal cortical activity. [ABSTRACT FROM AUTHOR]

Botulinum toxin (BTX) is an effective management method for spasticity in children with cerebral palsy (CP), but the short- medium- and long-term effects remain unclear. The primary objective was to quantify the effects of BTX injections on upper limb spasticity over time in children with CP. The secondary objective was to evaluate efficacy according to the International Classification of Functioning, Disability, and Health-Children & Youth version framework. We conducted a systematic review and meta-analysis of randomized controlled trials that included control/comparison groups treated with a placebo or other treatments. We searched CINAHL, Embase, PubMed, Scopus, Web of Science, and PsycINFO from their inception to April 2024. The pooled mean difference (MD) or standard mean difference (SMD) with 95 % CI was calculated using a random effects model at the short-term (up to 3 months), medium-term (3 to 6 months), and long-term (over 6 months). A total of 658 children with CP aged 1.8 to 19 years old in 12 eligible trials were involved. The primary outcome of the Melbourne Assessment percentile showed a significant increase in the medium- (MD = 2.63, 95 % CI 0.22 to 5.04, I² = 0 %) and long-term (MD = 4.72, 95 % CI 0.93 to 8.51, I² = 0 %) in favor of BTX. Pooled effects also showed that BTX significantly improved Modified Ashworth Scale scores in the short- (MD = -0.44, 95 % CI -0.88 to -0.01, I² = 88 %) and medium-term (MD = -0.20, 95 % CI -0.28 to -0.13, I² = 0 %), and individual goals and bimanual performance up to 6-months. No significantly higher risk of adverse events was observed with BTX. BTX injections sustainably improved the quality of affected upper limb function and temporarily improved individual goals and bimanual performance in children with CP. Our findings cautiously support a time interval of 3 to 6 months between BTX injections in the upper limbs of children with CP. This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (Registration ID: CRD42022323672). [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.

To identify the impact of upper limb spasticity on stroke survivors by linking their shared experience to the International Classification of Functioning, Disability, and Health (ICF). Ten community dwelling adults with a chronic stroke and spasticity, who had completed an upper limb rehabilitation trial participated in semi-structured interviews. Data were analysed using content analysis and linked to the ICF Comprehensive Core Set for stroke using standard linking rules. Four hundred and thirty-nine meaningful concepts eligible for linking were identified. The majority (n = 178) linked to Body Function, n = 137 to Activities and Participation, n = 115 to Environmental Factors, and n = 9 to Body Structures. Sixty-two of the 130 Comprehensive Core Set categories were used; an additional eight were required to fully represent experience. Stroke survivors with upper limb spasticity use words and discuss topics concentrated around mental functions, functions of the joints and bones, muscles and movements, carrying, moving and handling objects, support and relationships with immediate family and health professionals, products and technology, and health services. Half of the Comprehensive Core Set categories for stroke were relevant, but to adequately capture experience an additional eight were needed. The ICF category profile may be unique to our participants or may suggest further research is needed to determine if additions to core set categories are required. Our ICF mapping demonstrated that the Brief Core Set for stroke was not sufficient to capture the range of experience for stroke survivors with upper limb spasticity, instead the Comprehensive Core Set for stroke supplemented with eight clinical-cohort specific second-level-categories should be used. Our findings suggest that rehabilitation may better reflect lived experience if it focuses on Body Function (Chapters 1, 2, 4, 7), Activity and Participation (Chapters 1–9), and Environment (Chapters 1, 2, 3, 5) because Body Structure was rarely mentioned in this or previous post-stroke ICF mapping research. [ABSTRACT FROM AUTHOR]

Objective:To compare the clinical efficacy of Lidocaine local block combined with acupuncture-rehabilitation method and conventional acupuncture-rehabilitation method in the treatment of upper limb spasticity among post-stroke patients.Methods:Sixty cases of post-stroke upper limb spasticity patients who met the inclusion criteria in our hospital from June 2017 to June 2020, were selected. All the patients were randomly divided into observation group and control group, with 30 cases in each group. The control group was treated with conventional acupuncture-rehabilitation therapy, 6 times a week, for 4 weeks; the observation group was given Lidocaine local block therapy, 3 times a week, for 4 weeks. The Modified Ashworth Scale(MAS), Fugl-Meyer Assessment Upper Extremity(FMA-UE), Modified Barthel Index(MBI), and Active Range of Motion(AROM)scales were used to evaluate the changes of spasticity, motor function, activities of daily living, and elbow joint active range of motion.Results:There were no significant differences in MAS grade, FMA-UE, MBI, and AROM scores between the two groups before treatment(P>0.05), validating the comparisons between the two groups. The MAS grade, FMA-UE, MBI, and AROM scores of the two groups improved significantly after treatment compared with those before treatment, as the differences were statistically significant(PPP

Background: Upper limb spasticity (ULS) is a common complication after stroke, which seriously affects the quality of life and rehabilitation of patients. There are different treatment methods for post-stroke spasticity (PSS). Our group found that functional acupuncture (FA) can effectively improve forearm spasticity and hand dysfunction after stroke, but the efficacy of ULS needs to be further verified. Therefore, this subject has mainly used clinical randomized controlled trials to evaluate the clinical efficacy of FA in the treatment of ULS after ischemic stroke. Method: This is a parallel design and randomized controlled trial. We selected 108 patients who met the predefined criteria and randomized them into two groups, the experimental group and the control group. The experimental group receives FA and routine rehabilitation treatment. The control group received traditional acupuncture (TA) and routine rehabilitation treatment. All patients received 20 courses of treatment for 4 weeks, and the modified Ashworth score (MAS), clinical neurological deficit score (CSS), Fugl-Meyer upper extremity function assessment (FMA-UE), and the Modified Barthel Index (MBI) scores were evaluated before and after treatment. Discussion: This trial is mainly to study the clinical efficacy of FA in the treatment of ULS after ischemic stroke. It will not only provide a new idea for the clinical treatment of upper limb post-stroke spasticity (ULPSS) but also will provide effective experimental support and a theoretical basis for the clinic. Trial registration: China Clinical Trials Registry No. ChiCTR2100050440. Registered on 27 August 27 2021. [ABSTRACT FROM AUTHOR]

BackgroundUpper limb spasticity (ULS) is a common complication after stroke, which seriously affects the quality of life and rehabilitation of patients. There are different treatment methods for post-stroke spasticity (PSS). Our group found that functional acupuncture (FA) can effectively improve forearm spasticity and hand dysfunction after stroke, but the efficacy of ULS needs to be further verified. Therefore, this subject has mainly used clinical randomized controlled trials to evaluate the clinical efficacy of FA in the treatment of ULS after ischemic stroke.MethodThis is a parallel design and randomized controlled trial. We selected 108 patients who met the predefined criteria and randomized them into two groups, the experimental group and the control group. The experimental group receives FA and routine rehabilitation treatment. The control group received traditional acupuncture (TA) and routine rehabilitation treatment. All patients received 20 courses of treatment for 4 weeks, and the modified Ashworth score (MAS), clinical neurological deficit score (CSS), Fugl-Meyer upper extremity function assessment (FMA-UE), and the Modified Barthel Index (MBI) scores were evaluated before and after treatment.DiscussionThis trial is mainly to study the clinical efficacy of FA in the treatment of ULS after ischemic stroke. It will not only provide a new idea for the clinical treatment of upper limb post-stroke spasticity (ULPSS) but also will provide effective experimental support and a theoretical basis for the clinic.Trial registrationChina Clinical Trials Registry No. ChiCTR2100050440. Registered on 27 August 27 2021.

To evaluate the costs and benefits associated with the use of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) for lower limb spasticity in children, upper and lower limb spasticity in adults, and cervical dystonia in adults. This pharmacoeconomic analysis compared aboBoNT-A with onaBoNT-A. A decision tree model with a 1-year time horizon was conducted from a UK National Health Service (NHS) perspective using data from a variety of sources: randomized controlled trials (RCTs), network meta-analyses (NMAs), observational studies, and a physician survey investigating treatment patterns and resource utilization. Four patient populations were included: pediatric patients with lower limb spasticity (PLL), and adults with upper limb spasticity (AUL), lower limb spasticity (ALL), and cervical dystonia (CD). Outcomes included costs, quality-adjusted life years (QALYs) gained, cost per responder, and incremental cost per QALY gained. The effectiveness of each treatment was evaluated as a response to treatment. The base case assumption was that all patients in the model continued to receive botulinum toxin type A (BoNT-A) treatments at regular intervals regardless of treatment response status. Scenario analysis evaluated the impact of discontinuing BoNT-A for patients without a response to the first injection. The model found that aboBoNT-A resulted in greater quality-of-life and lower costs compared with onaBoNT-A for the management of spasticity and CD in all included indications. Across populations, cost savings ranged from £304 to £3,963 and QALYs gained ranged from 0.010 to 0.02 over a 1-year time horizon. Results were robust to scenario analyses and were driven by the impact of treatment response on health-related quality-of-life. AboBoNT-A was associated with higher treatment response, improved quality-of-life, and reduced costs in spasticity and CD versus onaBoNT-A. These findings could help deliver more effective and efficient healthcare in the NHS. The objective of this study was to compare the costs and health outcomes associated with abobotulinumtoxinA (aboBoNT-A; Dysport) and onabotulinumtoxinA (onaBoNT-A; Botox) for treating children and adults with a variety of conditions related to limb spasticity and cervical dystonia. Therapies such as aboBoNT-A and onaBoNT-A have been shown to reduce spasticity, deformity, pain, and cervical dystonia symptoms. They can also improve function, movement, and self-care abilities. We estimated the treatment costs for patients with spasticity and patients with cervical dystonia receiving aboBoNT-A and onaBoNT-A in the UK. We also estimated other health-related costs that patients were expected to incur while receiving these treatments, as well as their quality of life. For each indication (spasticity in the upper and lower limbs in adults and children, cervical dystonia in adults), research studies were identified to estimate the likelihood of patient response for aboBoNT-A and onaBoNT-A. Survey studies were assessed to understand use of health services and costs for patients who respond to therapy vs. those who do not. We estimated total costs over one year and expected quality of life for patients. Costs included the costs of aboBoNT-A and onaBoNT-A treatments, as well as other health services. In all identified studies, the likelihood of response was higher for aboBoNT-A than for onaBoNT-A. This was associated with reduced need for other health services (and therefore lower costs), and better quality of life for patients receiving aboBoNT-A. In addition, the cost per year of aboBoNT-A treatment was lower than onaBoNT-A treatment for all indications. Therefore, treatment with aboBoNT-A was consistently associated with lower costs and better quality of life. This outcome is referred to as "economically dominant," meaning that from a health economic perspective, aboBoNT-A would be preferred to onaBoNT-A for treating patients with spasticity or cervical dystonia. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare clinical- and cost-effectiveness of type A botulinum toxin (BoNT-A) therapies for management of pediatric upper limb spasticity, including AbobotulinumtoxinA (aboBoNT-A) and Onabotulinumtoxin A (onaBoNT-A). Methods: Systematic literature review and indirect treatment comparisons were conducted of randomized controlled trials reporting efficacy and safety outcomes. Efficacy was characterized by Modified Ashworth Scale (MAS) and Ashworth Scale (AS) up to 16-weeks post-injection. Results were used to inform a cost-effectiveness model with a 1-year time horizon, linking response rates with healthrelated quality-of-life (HRQoL) outcomes and costs from a UK perspective. Other data sources included in the cost-effectiveness model were drug unit costs, health care resource utilization based on UK physician survey, and HRQoL impacts of adverse events associated with oral anti-spasticity therapies. Results were characterized as cost per quality-adjusted life year and cost per responder. Results: Six studies were included in evidence syntheses. There was a trend towards greater response rate for aboBoNT-A which resulted in improved HRQoL and lower annual costs compared with onaBoNT-A. Safety outcomes were similar across BoNT-A therapies. In cost-effectiveness analysis, aboBoNT-A was an economically dominant therapy with respect to cost per quality-adjusted life year. The cost per responder at 1 year was estimated to be £39,056 for aboBoNT-A vs. £54,831 for onaBoNT-A. Limitations and conclusions: Based on observed safety and efficacy data, aboBoNT-A is estimated to result in higher treatment response and consequently increased quality-of-life and reduced costs, vs. onaBoNT-A in children with upper limb spasticity. Limitations to the study include study heterogeneity limited details available for onaBoNT-A studies (e.g. use of physical therapy), and limited availability of responder data. Where assumptions were required, they were made to be conservative towards aboBoN-A. [ABSTRACT FROM AUTHOR]

This article reviews the recent advances or nerve-oriented surgical procedures in the treatment of the spastic upper limb. The idea to intervene on the nerve is not recent, but new trends have developed in nerve surgery over the past few years, stimulating experiments and research. Specific surgical procedures involving the nerves have been described at different levels from proximal to distal: at the cervical spinal cord and the dorsal root entry zone (rhizotomy), at the level of the roots (contralateral C7 transfer) or in the peripheral nerve, within the motor trunk (selective neurectomy) or as its branches penetrate the muscles (hyperselective neurectomy). All of these neurosurgical procedures are only effective on spasticity but do not address the other deformities, such as contractures and motor deficit. Additional procedures may have to be planned in conjunction with nerve procedures to optimize outcomes., Competing Interests: Declaration of conflicting interestsThe authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Identifying patients who can gain minimal clinically important difference (MCID) in active motor function in the affected upper extremity (UE) after a botulinum toxin A (BoNT-A) injection for post-stroke spasticity is important. Eighty-eight participants received a BoNT-A injection in the affected UE. Two outcome measures, Fugl–Meyer Assessment Upper Extremity (FMA-UE) and Motor Activity Log (MAL), were assessed at pre-injection and after 24 rehabilitation sessions. We defined favorable response as an FMA-UE change score ≥5 or MAL change score ≥0.5.Statistical analysis revealed that the time since stroke less than 36 months (odds ratio (OR) = 4.902 (1.219–13.732); p = 0.023) was a significant predictor of gaining MCID in the FMA-UE. Medical Research Council scale -proximal UE (OR = 1.930 (1.004–3.710); p = 0.049) and post-injection duration (OR = 1.039 (1.006–1.074); p =0.021) were two significant predictors of MAL amount of use. The time since stroke less than 36 months (OR = 3.759 (1.149–12.292); p = 0.028), naivety to BoNT-A (OR = 3.322 (1.091–10.118); p = 0.035), and education years (OR = 1.282 (1.050–1.565); p = 0.015) were significant predictors of MAL quality of movement. The findings of our study can help optimize BoNT-A treatment planning.

Introduction: Approximately 15 million people suffer a stroke annually, up to 40% of which may develop spasticity, which can result in impaired limb function, pain and associated involuntary movements affecting motor control. Robust clinical data on spasticity progression, associated symptoms development and functional impairment is scarce. Additionally, maximal duration of muscle tone reduction following botulinum toxin type A (BoNT-A) injections remains undetermined. The ONTIME pilot study aims to explore these issues and evaluate whether abobotulinumtoxinA 500 U (Dysport®; Ipsen) administered intramuscularly within 12 weeks following stroke delays the appearance or progression of symptomatic (disabling) upper limb spasticity (ULS). Methods: ONTIME is a 28-week, phase 4, randomised, double-blind, placebo-controlled, exploratory pilot study initiated at four centres across Malaysia, the Philippines, Singapore and Thailand. Subjects (n = 42) with moderate to severe ULS (modified Ashworth scale [MAS] score ≥2) in elbow flexors or pronators, wrist flexors, or finger flexors will be recruited. Subjects will be randomised 2:1 to abobotulinumtoxinA 500 U or placebo (single dose 2–12 weeks after first-ever stroke). Primary efficacy will be measured by time between initial injection and visit at which reinjection criteria (MAS score ≥2 in the primary targeted muscle group and appearance or reappearance of symptomatic ULS) are met. Follow-up visits will be 4-weekly to a maximum of 28 weeks. Discussion: This pilot study will facilitate the design and sample size calculation of further confirmatory studies, and is expected to provide insights into the optimal management of post-stroke patients, including timing of BoNT-A therapy and follow-up duration.

Management of the upper limb in children with cerebral palsy is often complex and must be carried out by a team experienced in this field. Several clinical parameters must be taken into consideration, such as higher functions, visual problems, overall upper limb function, motor control, sensitivity, presence of hemineglect or synkinesis, limb position at rest and during walking. And last but not least, a complete analysis of the upper limb is required. It is only after this exhaustive assessment - which often includes occupational therapy, physiotherapy and in some cases, video and electromyography evaluations - that a treatment indication can be discussed with the patient's family. Other than baseline treatment consisting of rehabilitation, occupational therapy and bracing, botulinum toxin injections could be an option, targeting specific muscle groups. Surgical treatments, which are often indicated in severe forms with contractures, are proposed after the patient's case is presented at a multidisciplinary meeting. These include selective neurotomy, muscle-tendon release, transfer or lengthening, and procedures on bone and joints (osteotomy, arthrodesis). LEVEL OF EVIDENCE: Expert opinion., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to treat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the double-blind phase of this randomized, controlled trial, we compared the efficacy and safety of 400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups received 240 U onabotulinumtoxinA injected in the forearm. An additional 160 U onabotulinumtoxinA (400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group). Functional disabilities improved in both groups. No substantial difference was found in safety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U onabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar efficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed. This final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a wide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new safety concerns were identified. The dosing data in the open-label phase will inform optimal use of onabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167).

In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p < 0.001) and shorter time since stroke (p = 0.001). Patients setting goals for pain were older (p = 0.01) with more contractures (p = 0.008). The proportion of patients achieving their primary goal was not impacted by timing of first-ever BoNT-A injection (medium-term (≤1 year) vs. longer-term (>1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment.

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.

Background: Botulinum toxin type-A (BoNTA) is a recognized treatment for upper limb spasticity (ULS) after stroke, but there aren’t many studies analyzing its effect in shoulder muscles. Objective: To evaluate the efficacy of BoNTA injections for ULS, when shoulder muscles are included. Methods: A cross-sectional study. Data from clinical forms of outpatients, treated at a Rehabilitation Center (2001-2016). Analyzes: goals of treatment; demographic characteristics/goal; treatment success, using Goal Attainment Scaling. Results: Eighty-six stroke-patients, submitted to 547 BoNTA treatment sessions. The most injected shoulder muscles were subscapularis (SC) 35%, pectoralis major (PM) 31%, deltoideus 14%. The most selected goals for treatment were: involuntary movements (IM) 33%, pain/discomfort (PD) 26%, and mobility (MOB) 18%. Patients achieved or overachieved the IM goal in 76%, PD in 78%, and MOB in 79%. Patients with IM goal were younger (p < 0.01), than those setting other goal types; PD patients, were older (p < 0.019), treated half a year earlier (p < 0.01), and had more spasticity (MAS ≠ 0.15); MOB patients were younger (p = 0.04) and less spastic (MAS ≠ 0.12). Achieving PD goal impacted positively in improving MOB (p = 0.042) and passive function (p = 0.018). Conclusion: When treating ULS, including shoulder muscles, the most frequent goals were IM, PD e MOB. The most injected muscles were SC and PM. The treatment was successful in a large percentage of cases. Achieving the PD goal was associated with greater success at other goals of treatment. BoNTA demonstrated a positive effect in controlling symptoms and improving function. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy of single injections of abobotulinumtoxinA (Dysport) is established in adults with upper limb spasticity. In this study we assessed the effects of repeated injections of abobotulinumtoxinA over 1 year.Methods: Patients (n = 258, safety population) received 500 U, 1,000 U, or 1,500 U (1,500-U dose included 500-U shoulder injections) for up to 4 or 5 treatment cycles. Assessments included treatment-emergent adverse events (TEAEs), muscle tone, passive and active range of motion (XV1, XA ), angle of catch (XV3 ), Disability Assessment Scale (DAS) score, Modified Frenchay Scale (MFS) score, and Physician Global Assessment (PGA) score.Results: The incidence of TEAEs decreased across cycles. Muscle tone reduction and XV1 remained stable across cycles, whereas XV3 and XA continued to improve at the finger, wrist, and elbow flexors. DAS and PGA improved across cycles. MFS improved best with 1,500 U.Discussion: A favorable safety profile and continuous improvements in active movements and perceived and active function were associated with repeated abobotulinumtoxinA injections in upper limb muscles. Muscle Nerve 57: 245-254, 2018. [ABSTRACT FROM AUTHOR]

Stroke imposes significant burdens on health services and society, and as such there is a growing need to assess the cost-effectiveness of stroke treatment to ensure maximum benefit is derived from limited resources. This study compared the cost-effectiveness of treating post-stroke upper limb spasticity with botulinum toxin type A plus an upper limb therapy programme against the therapy programme alone. Data on resource use and health outcomes were prospectively collected for 333 patients with post-stroke upper limb spasticity taking part in a randomized trial and combined to estimate the incremental cost per quality adjusted life year (QALY) gained of botulinum toxin type A plus therapy relative to therapy alone. The base case incremental cost-effectiveness ratio (ICER) of botulinum toxin type A plus therapy was £93,500 per QALY gained. The probability of botulinum toxin type A plus therapy being cost-effective at the England and Wales cost-effectiveness threshold value of £20,000 per QALY was 0.36. The point estimates of the ICER remained above £20,000 per QALY for a range of sensitivity analyses, and the probability of botulinum toxin type A plus therapy being cost-effective at the threshold value did not exceed 0.39, regardless of the assumptions made.

The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2–12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies.

Background and Objective: Transcranial magnetic stimulation and peripheral repetitive magnetic stimulation (rPMS), as non-invasive neuromodulation techniques, can promote functional recovery in patients with post-stroke spasticity (PSS), but the effects of transcranial magnetic stimulation combined with peripheral magnetic stimulation on PSS remain largely unknown. Therefore, we examined the effects of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) combined with rPMS on PSS patients and its potential neural correlates to behavioral improvements., Methods: Forty-nine PSS patients were divided randomly into three groups: a combined group ( n = 20), a LF-rTMS group ( n = 15), and a control group ( n = 14). The combined group received LF-rTMS and rPMS treatment, the rTMS group received LF-rTMS treatment, and the control group received only routine rehabilitation. All patients underwent Ashworth Spasm Scale (MAS), upper extremity Fugl-Meyer (FMA-UE), and modified Barthel Index (MBI) assessments before and after intervention. In addition, resting-state functional magnetic resonance imaging data were collected pre- and post-treatment to observe changes in the amplitude of low-frequency fluctuation (ALFF)., Results: The MAS score was decreased, FMA-UE score and MBI scores were increased in the three groups after therapy than before therapy (all P < 0.05). In particular, the combined group showed significant effect on improved motor function and relieved spasticity in PSS ( P < 0.01). Moreover, the combined treatment increased ALFF values mainly in the right supplementary motor area, right middle frontal gyrus, and right cerebellum, while reduced ALFF values mainly in the right post-central gyrus compared with pre-treatment. Compared with the LF-rTMS and control groups, the combined treatment increased ALFF values in the right cerebellum and reduced ALFF values mainly in the frontoparietal cortex. Improvements in the MAS score were positively correlated with the change in ALFF values in the right cerebellum ( r = 0.698, P = 0.001) and the right supplementary motor area ( r = 0.700, P = 0.001) after combined treatment., Conclusion: Transcranial combined with peripheral repetitive magnetic stimulation could improve spastic state and motor function in PSS patients, and this effect may be associated with altered cerebellar and frontoparietal cortical activity., Clinical Trial Registration: http://www.chictr.org.cn/index.aspx, identifier ChiCTR1800019452., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Qin, Liu, Zhang, Wu and Wang.)

The main purpose of this study was to determine the clinical, electrophysiological and thermal effects of radial extracorporeal shock wave (rESW) stimulation on upper limb muscles affected by spasticity in patients with chronic stroke. Patients included in the study were randomly assigned into the following two groups: 30 patients stimulated with active rESW (A); and 30 patients stimulated with placebo rESW (B). All patients were analyzed using the Modified Ashworth Scale (MAS) to test the spasticity levels of the elbow (E), radio carpal (RC) and fingers (FF) joints; surface electromyography (sEMG) was performed for the resting bioelectrical activity registration of the flexor carpi radialis (FCR) and flexor carpi ulnaris (FCU) muscles; and infrared thermal imaging (IRT) was used to assess the temperature distributions of the carpal flexor muscles (CFM). All assessments were performed at baseline (t0), immediately after rESW (t1) as well as 1 and 24 h following its finalization (t2 and t3). Patients treated with active rESW showed a statistically significant reduction in the MAS score for the RC joint at t1 and for the FF joints at t1, t2 and t3 (p < 0.05). A significant decrease in sEMG activity was observed in the FCR and FCU muscles at t1, t2 and t3 (p < 0.05); significant increases in the mean and maximum values of the IRT detection was observed using inter-group comparisons in t2 and t3 (p < 0.05). No significant alterations were observed in patients after placebo rESW stimulation (p > 0.05). Applications of rESW demonstrating positive effects at reducing the level of spastic hypertonia of the upper limb muscles in patients with chronic stroke. ESW treatments should be considered as a potential anti-spastic effect to regulate vasculature. [ABSTRACT FROM AUTHOR]

Hematuria is a documented side effect of botulinum toxin injection and has only been reported when it is used for overactive bladder. Here we report a rare case of hematuria following onabotulinumtoxin A (Botox) injection for upper limb spasticity in a 29-year-old male with a history of traumatic brain injury and hemophilia. Hematuria resolved without further complication after self-injection of factor VIII as recommended by his hematologist. Botulinum toxin binds peripheral cholinergic nerve endings to prevent acetylcholine and norepinephrine exocytosis. Studies have shown that both of these compounds are involved in antifibrinolytic activation, suggesting botulinum toxin may play a role in the coagulation cascade by preventing formation of fibrin. This is further supported by resolution of hematuria in our patient after self-injection of factor VIII. As such, botulinum toxin injection may result in mild spontaneous hemorrhage in patients with underlying hematological deficiencies. Further studies are needed to elucidate its effects in coagulation. [ABSTRACT FROM AUTHOR]

In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p < 0.001) and shorter time since stroke (p = 0.001). Patients setting goals for pain were older (p = 0.01) with more contractures (p = 0.008). The proportion of patients achieving their primary goal was not impacted by timing of first-ever BoNT-A injection (medium-term (⩽1 year) vs. longer-term (>1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment. [ABSTRACT FROM AUTHOR]

Spasticity is a common disabling symptom for several neurological conditions. Botulinum toxin type A injection represents the gold standard treatment for focal spasticity with efficacy, reversibility, and low prevalence of complications. Current guidelines suggest a dose up to 600 units (U) of onabotulinumtoxinA/incobotulinumtoxinA or up to 1500 U of abobotulinumtoxinA to treat post-stroke spasticity to avoid important adverse effects. However, recently, higher doses of botulinum toxin type A were employed, especially in case of upper and lower limb severe spasticity. With searches of US National Library of Medicine databases, we identified all studies published from December 1989 to July 2014 concerning the use of higher doses of this neurotoxin for spasticity treatment with at least a dose of 600 U of onabotulinumtoxinA and incobotulinumtoxinA or 1800 U of abobotulinumtoxinA. The cumulative body of evidence coming from the eight studies selected suggested that higher doses of botulinum toxin type A appeared to be efficacious in reducing spasticity of the upper and lower limbs after stroke, with adverse effects generally mild. However, further investigations are needed to determine the safety and reproducibility in larger case series or randomized clinical trials of higher doses of botulinum toxin type A also after repeated injections. [ABSTRACT FROM AUTHOR]

Upper limb casts have been recommended for stroke survivors with moderate to severe spasticity. The objective of this article is to (a) review the rationale of 2 theoretical models that address spasticity and its consequences, (b) describe 4 casting options reported in the literature, (c) present the evidence for each cast type, and (d) suggest techniques that ensure safe and efficient fabrication of casts. This review underscores the critical need for high-evidence research on the efficacy of casting and the potential long-term benefits to this population. Current evidence lacks controlled research designs, robust sample sizes, and sensitive outcome measures. However, selective groups of stroke survivors have benefited from each type of casting. Future studies are required to assess the impact of casting on upper limb function, especially for those persons with wrist and hand spasticity, and to evaluate the efficacy of those casts not widely adopted in current practice such as inhibitory and drop-out casts. [ABSTRACT FROM AUTHOR]

Abstract: Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of spasticity associated with the upper motor neuron syndrome (UMNS), an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials. Evidence tables generated in the 2008 Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (AAN) review of the use of BoNT for autonomic disorders were also reviewed and updated. The panel evaluated evidence at several levels, supporting BoNT as a class, the serotypes BoNT-A and BoNT-B, as well as the four individual commercially available formulations: abobotulinumtoxinA (A/Abo), onabotulinumtoxinA (A/Ona), incobotulinumtoxinA (A/Inco), and rimabotulinumtoxinB (B/Rima). The panel ultimately made recommendations on the effectiveness of BoNT for the management of spasticity, based upon the strength of clinical evidence and following the AAN classification scale. While the prior report by the AAN provided recommendations for the use of BoNT as a class of drug, this report provides more detail and includes recommendations for the individual formulations. For the treatment of upper limb spasticity, the evidence supported a Level A recommendation for BoNT-A, A/Abo, and A/Ona, with a Level B recommendation for A/Inco; there was insufficient evidence to support a recommendation for B/Rima. For lower limb spasticity, there was sufficient clinical evidence to support a Level A recommendation for A/Ona individually and BoNT-A in aggregate; the clinical evidence for A/Abo supported a Level C recommendation; and there was insufficient information to recommend A/Inco and B/Rima (Level U). There is a need for further comparative effectiveness studies of the available BoNT formulations for the management of spasticity. [Copyright &y& Elsevier]

Stroke imposes significant burdens on health services and society, and as such there is a growing need to assess the cost-effectiveness of stroke treatment to ensure maximum benefit is derived from limited resources. This study compared the cost-effectiveness of treating post-stroke upper limb spasticity with botulinum toxin type A plus an upper limb therapy programme against the therapy programme alone. Data on resource use and health outcomes were prospectively collected for 333 patients with post-stroke upper limb spasticity taking part in a randomized trial and combined to estimate the incremental cost per quality adjusted life year (QALY) gained of botulinum toxin type A plus therapy relative to therapy alone. The base case incremental cost-effectiveness ratio (ICER) of botulinum toxin type A plus therapy was £93,500 per QALY gained. The probability of botulinum toxin type A plus therapy being cost-effective at the England and Wales cost-effectiveness threshold value of £20,000 per QALY was 0.36. The point estimates of the ICER remained above £20,000 per QALY for a range of sensitivity analyses, and the probability of botulinum toxin type A plus therapy being cost-effective at the threshold value did not exceed 0.39, regardless of the assumptions made. [ABSTRACT FROM AUTHOR]

Background: Botulinum toxin A injections are indicated for the management of movement disorders, including upper limb spasticity. The aim of this study was to compare the cost per patient per injection for two botulinum toxin A preparations in 19 countries. Methods: Doses of botulinum toxin A are expressed in noninterchangeable units (U), ie, Botox® in 100 Allergan units (100 U) and Dysport® in 500 Speywood units (500 U). Recommended dosages were derived from country-specific summaries of product characteristics or prescribing information. Cost analysis was based on official list prices and expressed in 2011 Euros. The cost per patient per injection was calculated using the recommended dosage in upper limb spasticity combined with price per vial in each country. Results: For upper limb spasticity, the recommended dosage for Dysport in the summary of product characteristics is 1000 U per patient, whereas for Botox the recommended dosage when recommendations were made is 300 U. Allowing for different prices per vial in each country, the cost per patient per injection for upper limb spasticity was less for Dysport than for Botox in 18 (95%) of the 19 countries (mean 17% less across countries). The difference was 20% or higher in nearly half (47%) of the countries. Sensitivity analyses considering available "real-world" dosing showed consistent results, with Dysport being less costly than Botox in all 19 countries. Conclusion: Considering costs per patient per injection based on analysis of recommended dosages in the summary of product characteristics, Dysport remains cheaper than Botox in most countries. Thus, when extrapolated to a national level, substantial savings could be realized by using Dysport in the treatment of upper limb spasticity. [ABSTRACT FROM AUTHOR]

Abstract: This study assessed treatment consistency of botulinum toxin administration in spastic upper limbs under pragmatic conditions, as derived through stability of dosages and between injections intervals. Over a period of 8 years, 153 children (81 with bilateral spastic cerebral palsy, 72 with unilateral) were treated according to accepted, experience-based guidelines with Botox and Dysport. Treatment response was based on assessment of spasticity and attainment of pre-determined goals at 3, 6 and 12 months post each treatment. Mean age at treatment onset was 6y 4mo (SD: 4y 10mo), median F/U, 2.5 years (4 months–6 8/12 years). Number of injection sessions was 1–10; few had more than 6 sessions. In 106 (69.28%) children, more than one anatomic regions of the limb were injected. Most (56.2%), had at least two injection sessions; median time interval between the sessions was 9 months (IQR: 4–35 months, similar for unilateral and bilateral cerebral palsy, p = 0.874). Children >4 years old at the first treatment had longer intervals between sessions (25.8%) compared to younger ones (p = 0.010). The mixed effects models demonstrated that botulinum toxin dosage was stable over subsequent visits (p = 0.144) and that intermediate intervals for subsequent visits were similar to the first one (p = 0.279). [Copyright &y& Elsevier]

Objective: The objective was to assess the outcome of selective motor fasciculotomy in relieving upper limb harmful resistant spasticity and thereby to improve motor functions in persons with cerebral palsy. Materials and Methods: Twenty people having cerebral palsy (12 females and 8 males) with age ranging from 5 to 35 (mean 12.85) years with upper limb resistant spasticity due to spastic hemiplegia (n=7), triplegia (n=6), and quadriplegia (n=7) were assessed using Modified Ashworth Scale, Selective Voluntary Control Grade, Wee FIM Scale and hand function evaluation. Selective motor fasciculotomy was performed on the musculocutaneous nerve (n=13) for elbow flexors spasticity, median nerve (n=24) for pronators and radial wrist flexors spasticity and ulnar nerve (n=3) for ulnar wrist flexors spasticity. Pre- and post-op therapeutic exercises were performed. Results: Statistical analysis using the Wilcoxon Signed Ranks test showed significant reduction in spasticity and improvement in selective voluntary control, hand functions (grasp to hold a 2 inch rod), and Wee FIM (self-care domain in particular). There was no recurrence in spasticity and complications following surgery. Conclusions: The selective motor fasciculotomy of musculocutaneous, median, and ulnar nerves significantly reduces spasticity in the affected muscle groups and thereby improves the self-care (motor) functions in selected people with cerebral palsy who have harmful resistant spasticity without any organic shortening of the muscles. The procedure is safe and the spasticity does not recur. [ABSTRACT FROM AUTHOR]

Barnes M, Schnitzler A, Medeiros L, Aguilar M, Lehnert-Batar A, Minnasch P. Efficacy and safety of NT 201 for upper limb spasticity of various etiologies – a randomized parallel-group study. Acta Neurol Scand: 2010: 122: 295–302. © 2010 John Wiley & Sons A/S. Objective – To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin®) in patients with upper limb spasticity of diverse etiology. Methods – Changes in functional disability and muscle tone from baseline to week 4 after NT 201 treatment. Results – One hundred ninety-two patients with stroke, brain injury, multiple sclerosis, or cerebral palsy were randomized to either 50 or 20 U/ml NT 201 dilutions. The maximum total NT 201 dose was 495 units. Four weeks post-injection, a ≥ 1-point reduction was observed on the Disability Assessment Scale in 57.1%, and on the Ashworth scale in ≥ 62.2% of patients. The 20 U/ml NT 201 dilution was non-inferior to the 50 U/ml NT 201 dilution. Global improvement was rated high by patients (80.2%) and investigators (89.0%). Conclusions – NT 201 improved functional disability and muscle tone and was well tolerated in patients with upper limb spasticity of diverse etiology in both dilutions. [ABSTRACT FROM AUTHOR]

Identifying patients who can gain minimal clinically important difference (MCID) in active motor function in the affected upper extremity (UE) after a botulinum toxin A (BoNT-A) injection for post-stroke spasticity is important. Eighty-eight participants received a BoNT-A injection in the affected UE. Two outcome measures, Fugl–Meyer Assessment Upper Extremity (FMA-UE) and Motor Activity Log (MAL), were assessed at pre-injection and after 24 rehabilitation sessions. We defined favorable response as an FMA-UE change score ≥5 or MAL change score ≥0.5.Statistical analysis revealed that the time since stroke less than 36 months (odds ratio (OR) = 4.902 (1.219–13.732); p = 0.023) was a significant predictor of gaining MCID in the FMA-UE. Medical Research Council scale -proximal UE (OR = 1.930 (1.004–3.710); p = 0.049) and post-injection duration (OR = 1.039 (1.006–1.074); p =0.021) were two significant predictors of MAL amount of use. The time since stroke less than 36 months (OR = 3.759 (1.149–12.292); p = 0.028), naivety to BoNT-A (OR = 3.322 (1.091–10.118); p = 0.035), and education years (OR = 1.282 (1.050–1.565); p = 0.015) were significant predictors of MAL quality of movement. The findings of our study can help optimize BoNT-A treatment planning. [ABSTRACT FROM AUTHOR]

Identifying patients who can gain minimal clinically important difference (MCID) in active motor function in the affected upper extremity (UE) after a botulinum toxin A (BoNT-A) injection for post-stroke spasticity is important. Eighty-eight participants received a BoNT-A injection in the affected UE. Two outcome measures, Fugl-Meyer Assessment Upper Extremity (FMA-UE) and Motor Activity Log (MAL), were assessed at pre-injection and after 24 rehabilitation sessions. We defined favorable response as an FMA-UE change score ≥5 or MAL change score ≥0.5.Statistical analysis revealed that the time since stroke less than 36 months (odds ratio (OR) = 4.902 (1.219-13.732); p = 0.023) was a significant predictor of gaining MCID in the FMA-UE. Medical Research Council scale -proximal UE (OR = 1.930 (1.004-3.710); p = 0.049) and post-injection duration (OR = 1.039 (1.006-1.074); p =0.021) were two significant predictors of MAL amount of use. The time since stroke less than 36 months (OR = 3.759 (1.149-12.292); p = 0.028), naivety to BoNT-A (OR = 3.322 (1.091-10.118); p = 0.035), and education years (OR = 1.282 (1.050-1.565); p = 0.015) were significant predictors of MAL quality of movement. The findings of our study can help optimize BoNT-A treatment planning.

In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to treat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the double-blind phase of this randomized, controlled trial, we compared the efficacy and safety of 400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups received 240 U onabotulinumtoxinA injected in the forearm. An additional 160 U onabotulinumtoxinA (400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group). Functional disabilities improved in both groups. No substantial difference was found in safety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U onabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar efficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed. This final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a wide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new safety concerns were identified. The dosing data in the open-label phase will inform optimal use of onabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167). [ABSTRACT FROM AUTHOR]