Post-stroke Upper-limb Spasticity Research Articles

Effectiveness of Extracorporeal Shock Wave Therapy after Botulinum Toxin Injection for Post-Stroke Upper Extremity Spasticity: A Randomized Controlled Study.

Post-stroke spasticity is a common complication that limits the functional performance of patients. Botulinum toxin (BTx) is an effective treatment for spasticity. Numerous researchers have applied extracorporeal shock wave therapy (ESWT) to address post-stroke spasticity, yielding positive clinical outcomes. We aimed to clarify the add-on effects of ESWT on BTx therapy for spasticity in patients with post-stroke. Sixteen eligible patients with upper extremity spasticity after stroke were recruited for this study. They were randomized to either a BTx with focused ESWT treatment group or a BTx alone group. Spasticity, measured using the modified Ashworth score (MAS) and modified Tardieu scale (MTS), showed statistically significant improvements in the elbow and wrist flexor muscles in both BTx + ESWT group and BTx alone groups. However, no significant differences were observed between the two groups with time flow. The BTx + ESWT group showed significantly decreased MAS of the finger flexors at follow-up and increased R1 (MTS) of the finger flexors at 3 weeks after treatment, which was not observed in the BTx alone group. This is the first study to identify the add-on effect of ESWT on BTx injections to improve post-stroke upper limb spasticity.

Botulinum toxin A injection for post-stroke upper limb spasticity and rehabilitation practices from centers across Asian countries.

Describe real-life practice and outcomes in the management of post-stroke upper limb spasticity with botulinum toxin A (BoNT-A) in Asian settings. Subgroup analysis of a prospective, observational study (NCT01020500) of adult patients (≥18 years) with post-stroke upper limb spasticity presenting for routine spasticity management, including treatment with BoNT-A. The primary outcome was goal attainment as assessed using goal-attainment scaling (GAS). Patients baseline clinical characteristics and BoNT-A injection parameters are also described. Overall, 51 patients from Asia were enrolled. Rates of comorbid cognitive and emotional problems were relatively low. Patients tended to have more severe distal limb spasticity and to prioritize active over passive function goals. Most (94.1%) patients in the subgroup were treated with abobotulinumtoxinA. For these patients, the median total dose was 500 units, and the most frequently injected muscles were the biceps brachii (83.3%), flexor carpi radialis (72.9%), and flexor digitorum profundus (66.7%). Overall, 74.5% achieved their primary goal and the mean GAS T score after one treatment cycle was 56.0 ± 13.0, with a change from baseline of 20.9 ± 14.3 (p < 0.001). The majority (96.1%) of Asian patients were rated as having improved. In the Asian treatment setting, BoNT-A demonstrated a clinically significant effect on goal attainment for the real-life management of upper limb spasticity following stroke.

Improving Upper Limb Spasticity in Patients with Stroke by Electroacupuncture Therapy: a Pre- and Post-Treatment Study.

: Post-stroke upper limb spasticity (PS-ULS) causes a decline in the quality of life of patients by reducing their ability to perform normal daily activities. : We performed pre- and post-treatment analyses of the changes in stroke patients with ULS following constant electroacupuncture therapy (EAT). : Thirty patients with PS-ULS underwent 12 sessions of EAT over 4 weeks. After performing acupuncture therapy at four acupoints on the affected arm (LI11, LI10, LI4, and TE5), electrostimulation (60 Hz) was performed for 20 min. The modified Ashworth scale (MAS) and the Fugl-Meyer assessment of the upper extremity (FMA-UE) were measured as the outcome variables. : Following EAT, there was a significant decrease in the elbow MAS score (p < 0.001), a significant decrease in the wrist MAS score (p < 0.01), and a significant increase in the FMA-UE score (p < 0.001). Adverse events related to EAT were not reported. : EAT decreased upper limb spasticity and improved functional recovery at the elbow and wrist. Large-scale and rigorous clinical trials are needed to verify the efficacy of EAT.

Wet cupping with rehabilitation training for upper-limb poststroke spasticity: A systematic review and meta-analysis of randomized controlled trials

BackgroundUpper-limb poststroke spasticity (PSS) negatively impacts on patients’ quality of life. An increasing number of clinical trials have indicated that wet cupping with rehabilitation training is conductive to alleviate spastic muscle tone, thereby to improve upper-limb function. However, related evidence base is insufficient. This study systematically investigates the efficacy and safety of wet cupping with rehabilitation training on stroke patients with upper-limb spasticity. MethodsEight separate databases and two clinical trial registries were searched from their inception to December 6, 2022. Two reviewers extracted the data and assessed the quality of the literature, independently. The mean difference (MD) or risk ratio (RR) were used as measure of effect size in meta-analysis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used for the certainty of evidence. ResultsEight randomized controlled trials (RCTs) were quantified for meta-analysis. The results indicated that in comparison with the control group, wet cupping with rehabilitation training was more effective in reducing modified Ashworth scale score (MD = −0.60, 95% CI: −0.74, −0.46; P < 0.00001) and the integral electromyography value of biceps muscle (MD = −4.71, 95% CI: −6.74, −2.67; P < 0.00001), but improving effective rate (RR = 1.28, 95% CI: 1.15, 1.41; P < 0.00001), Fugl-Myer Assessment score (MD = 4.84, 95% CI: 3.05, 6.64; P < 0.00001) as well as Barthel Index score (MD = 6.38, 95% CI: 2.20, 10.57; P = 0.003). However, no significant difference was found regarding the integral electromyography value of triceps muscle between groups (MD = 1.72, 95% CI: −2.05, 5.48; P = 0.37). ConclusionWet cupping with rehabilitation training should be included in a comprehensive therapeutic regimen for stroke patients with upper-limb spasticity. However, these results need to be further verified by more RCTs with rigorous design and large sample size.

Therapeutic Effect of Ipsilesional High-Frequency Repetitive Transcranial Magnetic Stimulation Following Local Botulinum Toxin Injection in Post-Stroke Upper Limb Spasticity

Therapeutic Effect of Ipsilesional High-Frequency Repetitive Transcranial Magnetic Stimulation Following Local Botulinum Toxin Injection in Post-Stroke Upper Limb Spasticity

Protocol for the SMART Study: Effectiveness and Safety of SMART AbobotulinumtoxinA Therapy in Patients With Chronic Post-Stroke Upper Limb Spasticity in a Real-World Setting

Protocol for the SMART Study: Effectiveness and Safety of SMART AbobotulinumtoxinA Therapy in Patients With Chronic Post-Stroke Upper Limb Spasticity in a Real-World Setting

Effects of Functional Acupuncture on Upper Limb Spasticity After Ischemic Stroke: A Protocol for a Randomized Controlled Parallel Clinical Trial.

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.

Effects of High-Intensity Electromagnetic Stimulation on Reducing Upper Limb Spasticity in Post-Stroke Patients

Super Inductive System (SIS) stimulation of spastic limbs by tissue-induced electromagnetic field may have the effect of reducing spasticity and improving functionality in patients with post-stroke spasticity. The aim of the study was to evaluate two different protocols for the application of SIS on upper limb spasticity after stroke. We included 60 patients with post-stroke upper limb spasticity, who were randomized into two groups: the study group, with a 9 min application protocol (1 min for agonist muscles, 8 min for antagonistic muscles); and the control group, with an 8 min protocol applied only to the antagonistic muscles. The duration of therapy was 10 days, and the results were assessed using the Modified Ashworth Scale (MAS) and the Barthel Index. Both the MAS and the Barthel Index improved significantly after 10 days of treatment (p &lt; 0.001), but 30 days after the completion of therapy, there was an attenuation of the effects in both study groups. The study group had a significantly higher percentage of patients with improved MAS after 10 days (p = 0.004) and within 30 days (p &lt; 0.001) than the control group. An SIS protocol applied on both agonist and antagonist muscles has a more pronounced and longer lasting spasticity-reducing and improved functionality effect than its application on only antagonistic muscles.

Splint efficacy in chronic post-stroke spasticity: a pilot study

IntroductionHand spasticity after stroke is a serious issue and may lead to hygiene problems, range of motion limitations, or contractures. Hand splints are often used to reduce spasticity and prevent movement limitations; however, there is little research available on the efficacy of splints in spasticity. The study aimed to investigate the efficacy of a reflex inhibitory splint (RIS) for upper extremity spasticity in stroke patients by using clinical and electrophysiological studies.MethodsStroke patients with elbow and hand spasticity were allocated into 2 groups. The splint group (&lt;i&gt;n&lt;/i&gt; = 16) wore RIS. The control group (&lt;i&gt;n&lt;/i&gt; = 13) did not wear any upper extremity splint. Both groups received the same rehabilitation program during this period. They were evaluated for motion in the upper extremity with the Brunnstrom scale and Fugl-Meyer upper extremity scale. Electrophysiological measurements showing motor neuron excitability such as the ratio between the maximum amplitude of H-reflex and the maximum amplitude of M-response (H&lt;sub&gt;max&lt;/sub&gt;/M&lt;sub&gt;max&lt;/sub&gt; ratio), H-reflex latency, and F-wave persistence and latency were also studied. All clinical and electrophysiological measurements were performed in both groups on days 0 and 15.ResultsAt the end of the treatment, elbow and finger flexion tonus decreased and active wrist extension angle increased in the splint treatment group compared with both baseline and the control group. Compared with the pre-treatment status, a correlation was detected between the H&lt;sub&gt;max&lt;/sub&gt;/M&lt;sub&gt;max&lt;/sub&gt; ratio and the wrist flexion tonus in the splint group.ConclusionsRIS may be useful for the management of post-stroke upper-limb spasticity.

Efficacy and safety of transcranial direct current stimulation for post-stroke spasticity: A meta-analysis of randomised controlled trials

Objectives: To evaluate the efficacy and safety of transcranial direct current stimulation for post-stroke spasticity and to assess its evidence using a meta-analysis. Methods: We searched the Cochrane Library, EMBASE, MEDLINE (via PubMed), PEDro, CBM, CNKI and Wan Fang Data from their inception to June 2021 for randomised clinical trials published in English or Chinese, which aimed to explore the effects of transcranial direct current stimulation on post-stroke spasticity. Two reviewers independently extracted the data and evaluated the methodological quality and overall evidence quality. Results: Thirteen randomised clinical trials comprising 924 patients were included, 12 of which were included in the meta-analysis. The results showed that anodal stimulation (standard mean difference = −0.91; [95% CI; −1.63 to −0.19]) combined with other therapies was more effective in improving upper limb spasticity. More than 20 minutes of stimulation were found to be effective in improving spasticity. Transcranial direct current stimulation was superior to the control treatments for subacute (standard mean difference = −1.16; −1.75 to −0.57) and chronic stroke (standard mean difference = −0.68; −1.13 to −0.22) patients aged under 60 (standard mean difference = −1.07; −1.54 to −0.60). No severe adverse events were reported in any of the included studies. Conclusions: Low-quality evidence demonstrates that anodal transcranial direct current stimulation as an adjunct is effective and safe in reducing upper limb post-stroke spasticity when applied for more than 20 minutes in subacute and chronic stroke survivors aged under 60. Further high-quality studies are needed to explore its long-term efficacy and safety.

Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis.

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

Duration of treatment effect using incobotulinumtoxinA for upper-limb spasticity: A post hoc analysis

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12-20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

Sustained efficacy of incobotulinumtoxinA in upper-limb post-stroke spasticity: A post hoc analysis

Sustained efficacy of incobotulinumtoxinA in upper-limb post-stroke spasticity: A post hoc analysis

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3–6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0−349) months, onset of spasticity and first injection was 22.7 (0−350) months and waiting time for a rehabilitation appointment was 9.0 (1−96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.

Arm spasticity after stroke: botulinum toxin therapy in combination with multimodal stimulation

Post-stroke spasticity (PS) occurs in most patients with stroke and contributes to the development of pain syndrome and contractures, which substantially impairs the restoration of lost motor functions (MFs) and the quality of life of the patient. Objective : to evaluate the efficacy of a combination of botulinum toxin A (BTA) and multimodal stimulation in patients with arm PS. Patients and methods . The investigation enrolled 84 patients aged 18 to 85 years with PS, who had experienced ischemic stroke (IS) 1 month to 1 year before. In the study group (n=56), complex rehabilitation treatment was preceded by the use of BTA, while in the control group (n=28), multimodal rehabilitation therapy was performed without using BTA. Before and after treatment, neurological deficit was evaluated using the modified Ashworth scale (MAS), the Fugl—Meyer (FM) assessment scale, the British muscle strength grading scale, the Action Research Arm Test (ARAT), the Barthel index, and the modified Rankin scale. Results and discussion . According to MAS, there was a statistically significantly spasticity reduction after BTA use in the study group compared to the control one (median 1 [1; 2] and 2 [2; 3] scores, respectively; p=0.0003). According to the FM scale, an improvement in arm MFs was noted in the study group compared to the control one (median 29.5 [20; 42] and 21 [13.5; 31.5] scores, respectively; p=0.008) and according to the ARAT scale this was observed in the study and control groups (14.5 [7; 27] and 3 [0; 12] scores, respectively; p=0.0004). In patients with upper limb PS, the use of BTA before a rehabilitation cycle using multimodal stimulation was shown to be statistically significantly more effective than the similar neurorehabilitation cycles without prior BTA therapy. The findings can be used in the routine practice of a neurologist when planning rehabilitation for more effective and well-founded treatment in patients with arm PS. Conclusion . Incorporation of BTA into multimodal stimulation was ascertained to be effective in patients with PS.

Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial

ObjectiveTo compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DesignProspective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial. SettingSeven university hospitals in the Republic of Korea. ParticipantsPatients (N=220) with poststroke upper limb spasticity. InterventionsAll participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group). Main Outcome MeasuresThe primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention. ResultsThe primary outcome was found to be −1.32±0.69 and −1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was −0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures. ConclusionsMT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.

Caregiver Delivered Sensory Electrical Stimulation for Post Stroke Upper Limb Spasticity: A Single Blind Crossover Randomized Feasibility Study

We developed a 64 channel sensory electrical stimulator which delivers a dynamic and variable ‘Sensory Barrage’ Stimulation (SBS). Our aim was to assess the feasibility of caregivers delivering the stimulation in the community for a clinical trial comparing single channel Transcutaneous Electrical Nerve Stimulation (TENS) with SBS for post stroke upper limb spasticity. We trained caregivers of 16 participants with post stroke upper limb spasticity to sequentially administer SBS and TENS for 60 min daily for four weeks each, with a washout period of two weeks in between. Outcome measures tested were recruitment and retention rates, compliance with interventions and daily recording of Participant -reported Numerical Rating Scale (NRS). We also collected results of Action Research Arm Test (ARAT), Leeds Arm Spasticity Impact Scale (LASIS) and Modified Ashworth Scale (MAS) for spasticity. Out of 21 potential participants, 16 consented and 15 completed the protocol. Ten participants received TENS for 80% (23/28) of the intended hours. Eleven participants completed NRS for at 80% (45/56) of the study days. All participants attended all visits. The MAS reduced by at least one in five participants after SBS and in three after TENS. Minimal Clinically Important Difference (MCID) of four points increase in ARAT was seen in five participants following TENS, and in four following SBS. A MCID of 18% decrease in NRS was reported by eight participants after TENS and three after SBS. This study demonstrated the feasibility of undertaking a trial of sensory electrical stimulation for post-stroke spasticity with caregivers delivering intervention in community. The study was not powered to detect efficacy of the interventions. Trial registration number: NCT02907775.Date 20-9-2016.

Botulinum Toxin Type A for Upper Limb Spasticity in Poststroke Patients: A Meta-analysis of Randomized Controlled Trials

Background and Aim: Botulinum toxin type A is considered to be an effective antispasmodic in recent years. We assess the effectiveness of botulinum toxin type A for the treatment of poststroke spasticity in the upper extremity using a meta-analysis. Methods: We searched several databases including PubMed, Web of Science, Embase, and Cochrane database for relevant studies, up until October 2017. All randomized controlled trials of botulinum toxin type A treat poststroke upper limb spasticity published were included. The primary outcome measure was modified ashworth score at the elbow, finger and wrist, pain score, and barthel index. Results: Ten randomized controlled trials were identified and reported sufficient data for inclusion in the pooled analysis (n = 950). The results of modified ashworth score at different joints, pain score, barthel index showed no difference was found in the effectiveness of botulinum toxin type A compared with placebo in the treatment of the upper limb spasticity after stroke. But modified ashworth score at the elbow was improver in Dysport subgroups (standardized mean difference [SMD] = −.39, 95%CI = −.67 to −.10, P = .008) compared with Botox subgroups (SMD = .08, 95%CI = −.68 to .83, P = .84). Conclusions: The meta-analysis of these studies showed that the overall effectiveness of botulinum toxin type A does not seem to differ from placebo for poststroke Patients. But the meta-analysis yielded a favorable effect of Dysport compared with placebo based on 4 trials.

Cost-Analysis of the Use of IncobotulinumtoxinA and AbobotulinumtoxinA for the Treatment of Post-Stroke Upper Limb Spasticity Based on Recommended Dosing for Muscles and Clinical Patterns (4779)

Cost-Analysis of the Use of IncobotulinumtoxinA and AbobotulinumtoxinA for the Treatment of Post-Stroke Upper Limb Spasticity Based on Recommended Dosing for Muscles and Clinical Patterns (4779)

Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE)

BackgroundUpper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan.MethodsIn the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32–40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed.ResultsAmong 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator’s Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events.ConclusionIncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.