Can Incobotulinumtoxin-A Treatment Improve Quality of Life Better Than Conventional Therapy in Spastic Muscle Post-Stroke Patients? Results from a Pilot Study from a Single Center (original) (raw)
Related papers
Journal of Neurology & Neurophysiology, 2013
Search of relevant studies was conducted on MEDLINE (from 1995 to July 2012), the Cochrane Central Register of Controlled Trials and EMBASE (1995 to July 2012). Search terms varied slightly across databases but included: "cerebrovascular accident" or "stroke" and the terms "botulinum toxin", "spasticity" as either MeSH terms, key words, or subject headings. Only randomized studies (RT) treating patients with UL post-stroke spasticity by BTX-A injection were included. Studies of treatment for both lower and/or UL spasticity were included if the results for patients with UL spasticity were reported separately. Prospective open label, case series, cohort studies and case reports were excluded. Furthermore, because confounding results, RTs were also excluded whether: i) post-stroke spasticity was treated by different serotype neurotoxin; ii) botulinum toxin was given early after the stroke, before clinical evidence of severe spasticity was established; iii) mixed sample of subjects with spasticity secondary to stroke or other neurological disorders was enrolled; iv) spasticity followed a non-Abstract Objective: Botulinum toxin type A (BTX-A) use reduces upper limb (UL) spasticity in stroke patients, but the effects on functional recovery remain uncertain. The aim of present review was to ascertain if the reduction of spasticity by use of BTX-A was linked to a functional gain of UL or in activity of daily living in post-stroke patients.
Trials, 2014
Background: Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications. Methods/Design: This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes. The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test-a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain.
Neurology international, 2018
The aim was to investigate if botulinum toxin type A (BTx-A) associated with physical therapy is superior to physical therapy alone in post stroke spasticity. A randomized, double-blinded controlled trial was performed in a rehabilitation unit on Northeastern, Brazil. Patients with post stroke spasticity were enrolled either to BTx-A injections and a pre-defined program of physical therapy or saline injections plus physical therapy. Primary endpoint was functional performance evaluated through time up and go test, six minutes walking test and Fugl-Meyer scale for upper limb. Secondary endpoint was spasticity improvement. Confidence interval was considered at 95%. Although there was a significant decrease in upper limbs flexor tonus (P<0.05) in the BTx-A group, there was no difference regarding functional performance after 9 months of treatment. When analyzing gait speed and performance, both groups showed a significant improvement in the third month of treatment, however it was n...
Journal of Rehabilitation Medicine, 2009
Objective: 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. Design: A multi-centre, randomized, double-blind, placebocontrolled study. Patients: Ninety-six patients were randomized (mean age 59.5 years) at least 6 months post-stroke. Mean time since stroke was 5.9 years. Methods: 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. Results: 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). Conclusion: 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.
Journal of Rehabilitation Medicine, 2011
To investigate the efficacy and safety of repeated treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in poststroke upper limb spasticity. Patients and design: After completing a double-blind, placebocontrolled, multicentre study (up to 20 weeks), 145 patients received up to 5 additional sets of NT 201 injections for an open-label extension period of up to 69 weeks. Methods: Upper limb muscle groups were treated as clinically indicated; injection intervals were ≥ 12 weeks. Outcome was assessed 4 weeks after each injection session and at the end of the study. Results: Muscle tone (flexors of wrist, elbow, finger, and thumb, and forearm pronators) improved throughout the study (response rate: up to 80.6%, p < 0.0001, Ashworth Scale). Continuous and significant improvements were also observed in disability (p < 0.05, Disability Assessment Scale). The majority of investigators, patients and caregivers rated NT 201 efficacy as very good or good (56-84%). Adverse events considered treatment-related occurred in 11% of patients. Formation of neutralizing antibodies was not observed in any patient after repeated treatments. Conclusion: Treatment with NT 201 showed sustained improvements in muscle tone and functionality (median dose 400 units) over a study duration of up to 89 weeks, and was well tolerated during repeated treatments for post-stroke upper limb spasticity.
Advances in Therapy
Introduction: The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults. Methods: Adults 18-80 years of age with poststroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebocontrolled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb. Efficacy assessments included evaluation of muscle tone using the Ashworth Scale (AS) and the Global Impression of Change Scale (GICS) assessed by the investigator, subject, and caregiver. The incidence of adverse events (AEs) was monitored throughout the OLEX. Results: A total of 296 of 299 subjects (99.0%) who completed the MP received incobotulinum-toxinA in the OLEX, and 248 subjects completed the 36-week OLEX. The proportion of subjects with at least a 1-point improvement in AS score from each incobotulinumtoxinA treatment to the Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.7284806.
Toxins
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 rehabilitatio...
Journal of the neurological sciences, 2017
Current guidelines suggested a dosage up to 600units (U) of botulinum toxin type A (BoNT-A) (onabotulinumtoxinA or incobotulinumtoxinA) in reducing spastic hypertonia with low prevalence of complications, although a growing body of evidence showed efficacy with the use of high doses (>800U). The available evidence mainly referred to a single set of injections evaluating the efficacy and safety of the neurotoxin 30days after the treatment. In a prospective, non-randomized, open-label study, we studied the safety of repeated higher doses of incobotulinumtoxinA in post-stroke upper and lower limb spasticity. Two years after the first set of injections, we evaluated in 20 stroke survivors with upper and lower limb spasticity the long-term safety of repeated high doses of incobotulinumtoxinA (up to 840U) for a total of eight sets of injections. Patients reported an improvement of their clinical picture concerning a reduction of spasticity measured with the Asworth Scale (AS) for elbow...
Toxins, 2021
Post-stroke spasticity impedes patients’ rehabilitation progress. Contradictory evidence has been reported in using Botulinum Neurotoxin type A (BoNT-A) to manage post-stroke lower extremity spasticity (PLES); furthermore, an optimum dose of BoNT-A for PLES has not yet been established. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to identify the efficacy and optimal dose of BoNT-A on PLES. "Meta" and "Metafor" packages in R were used to analyze the data. Hedges’ g statistic and random effect model were used to calculate and pool effect sizes. Twelve RCTs met the eligibility criteria. Muscle tone significantly improved in week four, week eight, and maintained to week twelve after BoNT-A injection. Improvements in functional outcomes were found, some inconsistencies among included studies were noticed. Dosage analysis from eight studies using Botox® and three studies using Dysport® indicated that the optimum ...