Treatment Of Upper Limb Spasticity Research Articles

Safety Profile of Repeat OnabotulinumtoxinA Doses of 400U for the Treatment of Upper Limb Spasticity (P4.334)

Safety Profile of Repeat OnabotulinumtoxinA Doses of 400U for the Treatment of Upper Limb Spasticity (P4.334)

Poster 339 Safety Profile of Repeat OnabotulinumtoxinA Doses of 400U for the Treatment of Upper Limb Spasticity

PM&RVolume 6, Issue 9S p. S303-S303 Saturday Poster Presentations - Poster Hall Poster 339 Safety Profile of Repeat OnabotulinumtoxinA Doses of 400U for the Treatment of Upper Limb Spasticity Lynn James, Lynn James Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorRozalina Dimitrova MD, MPH, Rozalina Dimitrova MD, MPH Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorGenming Shi, Genming Shi Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorCharles Asare MD, Charles Asare MD Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorCatherine Thompson PhD, Catherine Thompson PhD Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this author Lynn James, Lynn James Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorRozalina Dimitrova MD, MPH, Rozalina Dimitrova MD, MPH Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorGenming Shi, Genming Shi Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorCharles Asare MD, Charles Asare MD Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this authorCatherine Thompson PhD, Catherine Thompson PhD Allergan, Inc., Irvine, CA, United StatesSearch for more papers by this author First published: 29 September 2014 https://doi.org/10.1016/j.pmrj.2014.08.718Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume6, Issue9SSeptember 2014Pages S303-S303 RelatedInformation

Poster 351 A Mixed Treatment Comparison to Compare the Efficacy of Botulinum Toxin Type A Treatments for Upper Limb Spasticity

Poster 351 A Mixed Treatment Comparison to Compare the Efficacy of Botulinum Toxin Type A Treatments for Upper Limb Spasticity

AbobotulinumtoxinA for the treatment of upper limb spasticity

Upper limb spasticity is a common feature of many conditions arising from stroke, brain injury or progressive neurological illness and can cause significant disability. Current guidelines recommend first-line treatment with botulinum neurotoxin type A. This paper provides a comprehensive overview of one type of botulinum neurotoxin type A – abobotulinumtoxinA – including its mechanism of action, efficacy and safety. Overall, there is a wealth of evidence supporting the clinical efficacy of abobotulinumtoxinA in the management of spasticity. Key findings from randomized controlled and open-label naturalistic studies support abobotulinumtoxinA as an efficacious long-term treatment for upper limb spasticity, with benefits extending to overall patient function as well as direct improvements in muscle tone.

Arm Activity measure (ArmA) application for recording functional gain following focal spasticity treatment

Background and Aims: The Arm Activity measure (ArmA) is a new measure for recording the pattern of change in passive function after focal spasticity intervention. This study aimed to demonstrate the application of the ArmA for measuring passive and active functional movement. Methods An open-label prospective cohort study was conducted within a two-centre specialist spasticity management program. Outcome measures used were the ArmA, the Modified Ashworth Scale (MAS) and the Leeds Adult Spasticity Impact Scale (LASIS). Measurement was undertaken at baseline, at 8 weeks and at 16 weeks. Participants (n=58) presenting for treatment of upper limb spasticity were included and comprised of 32 men and 26 women, with a mean age of 47 years (SD=17.5). Participants received a single administration of BoNT (Dysport®, Ipsen, Slough, UK; or BOTOX®, Allergan, Irvine, CA, USA) following baseline assessment as part of routine clinical practice. Results Significant changes were demonstrated over the 16-week period in both the MAS (Xr2=66.6; P<0.005) and the ArmA passive function subscale (Xr2=11.9; P<0.005) (e.g. improved ease of dressing and hygiene). No change was identified in the ArmA active function subscale. Comparison of change at individual time-points showed the gain in passive function to be maintained at 16 weeks (Z=-2.6; P<0.01). Conclusion Significant gains in passive function were recorded by ArmA at 8 weeks, and maintained at 16 weeks post-injection in the context of on-going physical intervention.

Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

ObjectivesThis article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the...

Focal Muscle Vibration in the Treatment of Upper Limb Spasticity: A Pilot Randomized Controlled Trial in Patients With Chronic Stroke

Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. ObjectiveTo examine the clinical effect of repetitive focal muscle vibration (rMV) on the motor function of the upper extremity 1 month after treatment in patients with chronic stroke. DesignWe performed a pilot randomized controlled trial using a double-blind, parallel-group study design. SettingMedical center. ParticipantsPatients with chronic stroke (N=49). InterventionsPatients randomly assigned to the study group (SG) received rMV, while patients in the control group (CG) received a placebo vibratory treatment. The patients and the clinical examiner were blind to the intervention. Main Outcome MeasuresThe primary endpoint was an improvement of more than .37 points on the Functional Ability Scale of the Wolf Motor Function Test (WMFT FAS). The Modified Ashworth Scale and the visual analog scale were the secondary outcome measures. All measures were administered before the treatment (t0) and 1 week (t1) and 1 month (t2) after the treatment. ResultsTwenty-eight patients were allocated to the SG and 21 to the CG. The analysis of variance for repeated measurements revealed a significant difference in the expression of the WMFT FAS score over time only in the SG (P=.006). The treatment was successful for 7 (33%) of 21 patients recruited in the SG and for 2 (13%) of 15 patients recruited in the CG. The relative risk was 2.5 (95% confidence interval, .60–10.39), and the number needed to treat was 5. The Wilcoxon test showed a statistically significant difference between t0 and t2 in the SG (P=.02). No adverse event was observed in the 2 groups. ConclusionsOur results suggest that rMV treatment of the upper limb may improve the functional ability of chronic stroke patients, but a larger, multicenter, randomized controlled study is needed.

Resistência ao movimento e atividade eletromiográfica dos músculos flexores e extensores de cotovelo em pacientes hemiparéticos espásticos submetidos à crioterapia e estimulação elétrica neuromuscular

Spasticity often coexists with stroke due to an upper motor neuron lesion, which impacts the patient's quality of life. Therefore, the control of muscle tone through physical therapy such as cryotherapy and Neuromuscular Electrical Stimulation (NMES) is extremely important. Several studies have demonstrated their advantageous physiological effects. However, these studies have not provided sufficient scientific proof for the treatment of upper limb spasticity and the duration of the physiological effects after the therapy. Therefore, this work helps to establish an application protocol for cryotherapy and NMES in individuals with spastic hemiparesis. The resistance to movement of the elbow flexor and extensor muscles before and after application of cryotherapy and NMES was used to determine the effect of the therapies. The study included 15 stroke patients that required physical therapy for spastic hemiparesis. They included both sexes, mean age of 56 ± 16. An evaluation was performed before and after therapy, as well as 10, 20, and 30 minutes following the application, by means of surface electromyography (EMG). The resistance to movement was measured with an Isokinetic Dynamometer in the passive mode at an angular velocity of 30 and 150 o/s. Although not statistically significant (p < 0.05), the results showed a reduced resistance to passive movement of the elbow flexors and extensors after cryotherapy and NMES, allowing us to conclude that physical therapy effectively reduces the resistance to passive movement in spastic hemiparetic patients, however, they have different effects with respect to time.

Treatment of Upper Limb Spasticity after Stroke: One-Year Safety and Efficacy of Botulinum Toxin Type A NT201

A new preparation of botulinum toxin type A called NT 201, free from complexing proteins, potentially with low antigenicity has been used in the therapy of spasticity in stroke patients. This was an open-label study reported the safety and the efficacy of one-year treatment with NT 201 evaluating the therapeutic effect on functional disability and on quality of life in upper limb spasticity after stroke. Patients received a botulinum toxin therapy in the upper injected intramuscularly. After inoculation, patients were submitted to a motor rehabilitation program for upper limb injected three times/week. Re-treatment was permitted at 12 weeks after the prior treatment. Safety assessment included evaluation of adverse events and efficacy was measured by Modified Ashworth Scale for spasticity (MAS), Spasm Frequency Score (SFS) for the daily spasms, and Disability Assessment Scale (DAS) for disability. Of 35 consecutive patients (13 women and 12 men) screened for study eligibility, 20 (6 women and 14 men) patients (mean age 63,4±7,03) were included in this study and were submitted to NT 201 therapy for one year. At the baseline, botulinum toxin dose in the upper limb ranged from 160 to 450U, whereas total dose in the last treatment administrated was reduced respect the first injections ranging from 120 to 350U. All the enrolled patients completed the year-long study and reported an improvement of clinical picture. MAS, was statistically (px003C;0,001) reduced in all muscles at T1 (mean score ±SD: 2.65±0.67) and T2 (mean score±SD: 2.55±0.60) in comparison to the baseline T0 (mean score±SD: 3.9 ±0.78). Significant reduction (px003C;0,001) from baseline T0 (mean score ±SD: 3.25±0.78) was also noted in SFS at T1 (mean score ±SD: 1.55±0.51) and T2 (mean score±SD :1.30±0.47). The DAS score showed a reduction of the T1score (mean score ±SD: 1.70±0.47) and T2 score (mean score ±SD: 1,40 ±0,50) respect to baseline T0 score (mean score ±SD: 2,65 ±0,48) statistically significant (p≤003C;0,001). No adverse effects were observed in these patients. NT 201 appeared to be an efficacious and well-tolerated long-term treatment option for patients with upper limb spasticity after stroke, obtaining a substantial improvement in functional disability, muscle hypertone, and daily spasms.

Outcome of selective motor fasciculotomy in the treatment of upper limb spasticity

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.

Outcome of Selective Motor Fasciculotomy in the Treatment of Upper Limb Spasticity Due to Cerebral Palsy

Outcome of Selective Motor Fasciculotomy in the Treatment of Upper Limb Spasticity Due to Cerebral Palsy

Modified constraint-induced movement therapy or bimanual occupational therapy following injection of Botulinum toxin-A to improve bimanual performance in young children with hemiplegic cerebral palsy: a randomised controlled trial methods paper

BackgroundUse of Botulinum toxin-A (BoNT-A) for treatment of upper limb spasticity in children with cerebral palsy has become routine clinical practice in many paediatric treatment centres worldwide. There is now high-level evidence that upper limb BoNT-A injection, in combination with occupational therapy, improves outcomes in children with cerebral palsy at both the body function/structure and activity level domains of the International Classification of Functioning, Disability and Health. Investigation is now required to establish what amount and specific type of occupational therapy will further enhance functional outcomes and prolong the beneficial effects of BoNT-A.Methods/DesignA randomised, controlled, evaluator blinded, prospective parallel-group trial. Eligible participants were children aged 18 months to 6 years, diagnosed with spastic hemiplegic cerebral palsy and who were able to demonstrate selective motor control of the affected upper limb. Both groups received upper limb injections of BoNT-A. Children were randomised to either the modified constraint-induced movement therapy group (experimental) or bimanual occupational therapy group (control). Outcome assessments were undertaken at pre-injection and 1, 3 and 6 months following injection of BoNT-A. The primary outcome measure was the Assisting Hand Assessment. Secondary outcomes included: the Quality of Upper Extremity Skills Test; Pediatric Evaluation of Disability Inventory; Canadian Occupational Performance Measure; Goal Attainment Scaling; Pediatric Motor Activity Log; modified Ashworth Scale and; the modified Tardieu Scale.DiscussionThe aim of this paper is to describe the methodology of a randomised controlled trial comparing the effects of modified constraint-induced movement therapy (a uni-manual therapy) versus bimanual occupational therapy (a bimanual therapy) on improving bimanual upper limb performance of children with hemiplegic cerebral palsy following upper limb injection of BoNT-A. The paper outlines the background to the study, the study hypotheses, outcome measures and trial methodology. It also provides a comprehensive description of the interventions provided.Trial RegistrationACTRN12605000002684

BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

Objective To compare the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A plus an upper limb therapy programme with the upper limb therapy programme alone. Design A multicentre open-label parallel-group randomised controlled trial and economic evaluation. Setting Twelve stroke services in the north of England, UK. Participants Three hundred and thirty-three adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions The intervention group received botulinum toxin type A injection(s) plus a 4-week programme of upper limb therapy. The control group received the upper limb therapy programme alone. Participants were clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A injection(s) and/or therapy. Main outcome measures The primary outcome was upper limb function 1 month after study entry measured by the Action Research Arm Test (ARAT). A successful outcome was defined as: (1) a change of three or more points on the ARAT scale for a participant whose baseline ARAT score was between 0 and 3, (2) a change of six or more points on the ARAT scale for a participant whose baseline ARAT score was between 4 and 51, or (3) a final ARAT score of 57 for a participant whose baseline ARAT score was 52–56. Results Randomisation groups were well matched at baseline. There was no significant difference between the groups for the primary outcome of improved arm function at 1 month. This was achieved by 30/154 (19.5%) in the control group and 42/167 (25.1%) in the intervention group (p = 0.232). The relative risk of having a ‘successful treatment’ in the intervention group compared with the control group was 1.3 [95% confidence interval (CI) 0.9 to 2.0]. No significant differences in improved arm function were seen at 3 or 12 months. In terms of secondary outcomes, muscle tone/spasticity at the elbow was decreased in the intervention group compared with the control group at 1 month. The median change in the Modified Ashworth Scale was – 1 in the intervention group compared with zero in the control group (p < 0.001). No difference in spasticity was seen at 3 or 12 months. Participants treated with botulinum toxin type A showed improvement in upper limb muscle strength at 3 months. The mean change in strength from baseline (upper limb component of the Motricity Index) was 3.5 (95% CI 0.1 to 6.8) points greater in the intervention group compared with the control group. No differences were seen at 1 or 12 months. Participants in the intervention group were more likely to be able to undertake specific basic functional activities, e.g. dress a sleeve, clean the palm and open the hand for cutting fingernails. At 1 month, 109/144 (75.7%) of the intervention group and 79/125 (63.2%) of the control group had improved by at least one point on a five-point Likert scale for at least one of these tasks (p = 0.033). At 3 months the corresponding proportions were 102/142 (71.8%) of the intervention group and 71/122 (58.2%) of the control group (p = 0.027). Improvement was sustained at 12 months for opening the hand for cleaning the palm and opening the hand for cutting the nails but not for other activities. Conclusions The addition of botulinum toxin type A to an upper limb therapy programme to treat spasticity due to stroke did not enhance improvement in upper limb function when assessed by the prespecified primary outcome measure at 1 month. However, improvements were seen in muscle tone at 1 month, upper limb strength at 3 months, upper limb functional activities related to undertaking specific basic functional tasks at 1, 3 and 12 months, and upper limb pain at 12 months. Botulinum toxin was well tolerated and side effects were minor. The addition of botulinum toxin type A to an upper limb therapy programme for the treatment of upper limb spasticity due to stroke was not estimated to be cost-effective at levels of willingness to pay for a QALY set by NHS decision-makers. Trial registration ISRCTN78533119; EudraCT 2004–002427–40; CTA 17136/0230/001.

Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: A secondary analysis from a double-blind placebo-controlled randomized clinical trial

To examine goal attainment scaling for evaluation of treatment for upper limb post-stroke spasticity with botulinum toxin-A. Secondary analysis of a multi-centre double-blind, placebo-controlled randomized clinical trial. Six outpatient clinics in Australia. Patients (n=90) completing per protocol 2 cycles of treatment/placebo. Mean age 54.5 (standard deviation 13.2) years. Mean time since stroke 5.9 (standard deviation 10.5) years. Intramuscular botulinum toxin-A (Dysport 500-1000U) or placebo given at 0 and 12 weeks. Measurement points were baseline, 8 and 20 weeks. Individualized goal attainment and its relationship with spasticity and other person-centred measures - pain, mood, quality of life and global benefit. A significant treatment effect was observed with respect to goal attainment (Mann-Whitney z=-2.33, p< or = 0.02). Goal-attainment scaling outcome T-scores were highly correlated with reduction in spasticity (rho=0.36, p=0.001) and global benefit (rho=0.45, p<0.001), but not with other outcome measures. Goal-attainment scaling T-scores were lower than expected (median 32.4, interquartile range 29.6-40.6). Goals related to passive tasks were more often achieved than those reflecting active function. Qualitative analysis of goals nevertheless demonstrated change over a wide area of patient experience. Goal-attainment scaling provided a responsive measure for evaluating focal intervention for upper limb spasticity, identifying outcomes of importance to the individual/carers, not otherwise identifiable using standardized measures.

Innovative Approaches in the Treatment of Upper Limb Spasticity after Stroke

Innovative Approaches in the Treatment of Upper Limb Spasticity after Stroke

Botulinum toxin A for treatment of upper limb spasticity following stroke: A multi-centre randomized placebo-controlled study of the effects on quality of life and other person-centred outcomes

Botulinum toxin is known to relieve upper limb spasticity, which is a disabling complication of stroke. We examined its effect on quality of life and other person-centred perspectives. A multi-centre, randomized, double-blind, placebo-controlled study. Ninety-six patients were randomized (mean age 59.5 years) at least 6 months post-stroke. Mean time since stroke was 5.9 years. Patients received either botulinum toxin type A or placebo into the affected distal upper limb muscles on 2 occasions, 12 weeks apart. Assessment was undertaken at baseline, 8, 12, 20 and 24 weeks. The primary outcome measure was the Assessment of Quality of Life scale (AQoL). Secondary outcome assessments included Goal Attainment Scaling (GAS), pain, mood, global benefit, Modified Ashworth Scale (MAS), disability and carer burden. The groups did not differ significantly with respect to quality of life, pain, mood, disability or carer burden. However, patients treated with botulinum toxin type A had significantly greater reduction in spasticity (MAS) (p < 0.001), which translated into higher GAS scores (p < 0.01) and greater global benefit (p < 0.01). Although no change in quality of life was demonstrated using the AQoL, botulinum toxin type A was found to be safe and efficacious in reducing upper limb spasticity and improving the ability to achieve personal goals.

Influence of Botulinum Toxin Type A Treatment of Elbow Flexor Spasticity on Hemiparetic Gait

To assess whether walking velocity could be improved in patients with disorders related to upper-motor neuron syndrome (UMNS) by treating elbow flexor spasticity with botulinum toxin type A (BoNTA). This was a prospective, open-label, multicenter, interventional evaluation. The study group of 15 patients (mean age, 51.3 yrs; ten men, five women) were independent ambulators with residual hemiparesis attributable to stroke or traumatic brain injury of at least 18-mo duration. Patients were injected with 120-200 units of BoNTA (BOTOX, Allergan, Inc., Irvine, CA) to the affected biceps, brachialis, and/or brachioradialis. Modified Ashworth scores and gait velocity were assessed before and after BoNTA treatment. An untreated control group was employed to assess the potential impact of time on test-retest reliability of the selected temporal spatial gait parameters. The BoNTA group demonstrated a statistically significant increase in walking velocity from 0.56 m/sec before treatment to 0.63 m/sec after treatment (P = 0.037). The mean modified Ashworth score was significantly reduced from 2.6 before BoNTA treatment to 1.4 after treatment (P = 0.00003). Treatment of upper-limb spasticity may be an important adjuvant treatment for patients with gait disturbance related to the UMNS.

Poster Abstract #1: Passive and Active Functional Tasks Are the Main Reasons for Treatment of Upper Limb Spasticity in Post-Stroke Patients Among Neurologists, Physiatrists, and Primary Care Physicians

Poster Abstract #1: Passive and Active Functional Tasks Are the Main Reasons for Treatment of Upper Limb Spasticity in Post-Stroke Patients Among Neurologists, Physiatrists, and Primary Care Physicians

Article 12: Botulinum Neurotoxin Type A Versus Oral Tizanidine in the Treatment of Upper-Limb Spasticity: A Double-Blind, Placebo-Controlled, Multicenter Trial

Article 12: Botulinum Neurotoxin Type A Versus Oral Tizanidine in the Treatment of Upper-Limb Spasticity: A Double-Blind, Placebo-Controlled, Multicenter Trial

Toxine botulinique et pharmacie hospitalière

Botulinum toxin is a neurotoxic protein synthesized by Clostridium botulinum. Among approved indications for type A pharmaceutical formulations is the treatment of upper limb spasticity in post-stroke patients. Neurologists and rehabilitator physicians have extended their use to treat other types of muscles spasticity. In 2002, most of prescriptions in France were off-label. The activity of the R. Poincaré hospital is dedicated to treating handicapped patients. Working in close collaboration, prescribing physicians and hospital pharmacists elaborated a set of guidelines for the use of botulinum toxin type A. The protocol includes a specific order form, pharmaceutical validation of prescriptions and distribution follow-up. The numbers of prescriptions and treated patients have greatly increased from 2003 to 2005. As a consequence to the extension of marketing authorization for indications for the use of botulinum toxin type A in 2005, 77% of treated therapeutic indications are now compliant to marketing authorization specifications. Through prescription analysis, in-hospital pharmacists participate in the implementation of guidelines for follow-up and management of medical expenditures.