Archive for category Spasticity

[Abstract] Long-term safety of repeated high doses of incobotulinumtoxinA injections for the treatment of upper and lower limb spasticity after stroke

Highlights

    Current guidelines suggested a dosage up to 600 units (U) of botulinum toxin type A (BoNT-A) in post-stroke spasticityHigh doses of incobotulinumtoxinA (840U) showed efficacy and safety in severe post-stroke upper and lower limb spasticityIn a 2-year follow-up on 20 patients, a reduction of spasticity/disability was found with repeated high doses of incobotulinumtoxinAOne month after the last BoNT-A administration, the efficacy on spasticity/disability was similar to that at baselineLong-term treatment with high doses of incobotulinumtoxinA was safe and effective in post-stroke upper and lower limb spasticity

Abstract

Current guidelines suggested a dosage up to 600 units (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 (> 800 U). The available evidence mainly referred to a single set of injections evaluating the efficacy and safety of the neurotoxin 30 days 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 840 U) 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, wrist, fingers and ankle flexor muscles and disability measured with the Disability Assessment Scale (DAS) 30 days after the last set of injections (eighth set) compared to the baseline (p < 0.0001). No difference in AS and DAS scores has been found between t1 (30 days after the first injection set) and t2 (30 days after the eighth set of injections), with also similar safety.

In a two-year follow-up, repeated high doses of incobotulinumtoxinA, administered for eight sets of injections, appeared to be safe in patients with upper and lower limb spasticity after stroke without general adverse effects.

Keywords

via Long-term safety of repeated high doses of incobotulinumtoxinA injections for the treatment of upper and lower limb spasticity after stroke – ScienceDirect

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[ARTICLE] Treatment of Upper Limb Spasticity after Stroke: One-Year Safety and Efficacy of Botulinum Toxin Type A NT201 – Full Text PDF

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 (p<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 (p<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<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.

References

1. Lance, JW. Symposium synopsis, in Feldman, RG, Young, RR, Koella, WP, (eds) Spasticity: Disordered Motor Control, ChicagoYear Book Medical1980, pp. 48594Google Scholar
2. Barnes, MR, Upper motor neurone syndrome and spasticity. CambridgeCambridge Univ Pr2001Google Scholar
3. Young, RR. Spasticity: A review. Neurology 1994; 44 (suppl 9): 1220Google Scholar
4. Gracies, JM, Nance, P, Elovic, E, McGuire, J, Simpson, DM. Traditional pharmacological treatments for spasticity part II: General and regional treatments. Muscle Nerve 1997suppl 6S92120Google Scholar
5. Gormley, ME, O’Brien, CF, Yablon, SA. A clinical overview of treatment decisions in the management of spasticity. Muscle Nerve 1997suppl 6S1420Google Scholar
6. Brashear, A, Gordon, MF, Elovic, E, Kassicieh, VD, Marciniak, C, Do, M, Lee, CH, Jenkins, S, Turkel, C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after stroke. N Engl J Med 2002; 347: 395400Google ScholarCrossrefMedline
7. Simpson, DM, Gracies, JM, Graham, K, Hallett, M, Miyasaki, J, Naumann, M, Russman, B, Simpson, L, So, Y. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review). Neurology 2009; 73: 7367Google ScholarCrossref
8. Simpson, DM, Alexander, DN, O’Brien, CF, Tagliati, M, Aswad, AS, Leon, JM, Gibson, J, Mordaunt, JM, Monaghan, EP. Botulinum toxin type A in the treatment of upper extremity spasticity: A randomized, double blind, placebo controlled trial. Neurology 1996; 46: 130610 Google ScholarCrossrefMedline
9. Gracies, JM. Physical modalities other than stretch in spastic hypertonia. Phys Med Rehabil Clin N Am 2001; 12: 76992Google ScholarMedline
10. Lange, O, Bigalke, H, Dengler, R, Wegner, F, deGroot, M, Wohlfarth, K. Neutralizing antibodies and secondary therapy failure after treatment with botulinum toxin type A: Much ado about nothing? Clin Neuropharmacol 2009; 32:2138Google ScholarCrossrefMedline
11. Critchfield, J. Considering the immune response to botulinum toxin. Clin J Pain 2002; 18 (6 Suppl): S13341Google ScholarCrossrefMedline
12. Bohannon, RW, Smith, RB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987; 67: 2067Google ScholarCrossrefMedline
13. Snow, BJ, Tsui, JKC, Bhatt, MH, Varelas, M, Hashimoto, SA, Calne, DB. Treatment of spasticity with botulinum toxin: A double blind study. Ann Neurol 1990; 28: 51215Google ScholarCrossrefMedline
14. Brashear, A, Zafonte, R, Corcoran, M, Galvez-Jimenez, N, Gracies, JM, Gordon, MF, McAfee, A, Ruffing, K, Thompson, B, Williams, M, Lee, CH, Turkel, C. Inter- and intra rater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil 2002; 83: 134954Google ScholarCrossrefMedline
15. Elovic, EP, Brashear, A, Kaelin, D, Liu, J, Millis, SR, Barron, R, Turkel, C. Repeated treatments with botulinum toxin type a produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients. Arch Phys Med Rehabil 2008; 89: 799806Google ScholarCrossrefMedline
16. Gordon, MF, Brashear, A, Elovic, E, Kassicieh, D, Marciniak, C, Liu, J, Turkel, C. BOTOX Poststroke Spasticity Study Group. Repeated dosing of botulinum toxin type A for upper limb pasticity following stroke. Neurology 2004; 63: 19713Google ScholarCrossrefMedline
17. Lagalla, G, Danni, M, Reiter, F, Ceravolo, MG, Provinciali, L. Post-stroke spasticity management with repeated botulinum toxin injections in the upper limb. Am J Phys Med Rehabil 2000; 79: 37784Google ScholarCrossrefMedline
18. Bakheit, AM, Fedorova, NV, Skoromets, AA, Timerbaeva, SL, Bhakta, BB, Coxon, L. The beneficial antispasticity effect of botulinum toxin type A is maintained after repeated treatment cycles. J Neurol Neurosurg Psychiatry 2004; 75: 155861Google ScholarCrossrefMedline

via Treatment of Upper Limb Spasticity after Stroke: One-Year Safety and Efficacy of Botulinum Toxin Type A NT201 – P. Fiore, A. Santamato, M. Ranieri, R.G. Bellomo, R. Saggini, F. Panza, G. Megna, G. Cristella, M. Megna, 2012

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[ARTICLE] Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial – Full Text

Abstract

Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients. Botulinum toxin type A (BoNTA) has been shown effective for upper limb spasticity. This study assesses the treatment of lower limb spasticity in a large placebo-controlled clinical trial. In this multicenter, randomized, double-blind, parallel-group, placebo-controlled study, we evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke lower limb spasticity. One hundred twenty patients with lower limb spasticity were randomized to a single treatment with BoNTA 300 U or placebo. The tone of the ankle flexor was assessed at baseline and through 12 weeks using the Modified Ashworth Scale (MAS). Gait pattern and speed of gait were also assessed. The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS ankle score. Significant improvement in spasticity with BoNTA 300 U was demonstrated by a mean difference in the AUC of the change from baseline in the MAS ankle score between the BoNTA and placebo groups (−3.428; 95% CIs, −5.841 to −1.016; p = 0.006; t test). A significantly greater decrease from baseline in the MAS ankle score was noted at weeks 4, 6 and 8 in the BoNTA group compared to the placebo group (p < 0.001). Significant improvement in the Clinicians Global Impression was noted by the investigator at weeks 4, 6 and 8 (p = 0.016–0.048, Wilcoxon test), but not by the patient or physical/occupational therapist. Assessments of gait pattern using the Physician’s Rating Scale and speed of gait revealed no significant treatment differences but showed a tendency towards improvement with BoNTA. No marked difference was noted in the frequency of treatment-related adverse events between BoNTA and placebo groups. This was the first large-scale trial to indicate that BoNTA significantly reduced spasticity in lower limb muscles.

Introduction

Spasticity is defined by Lance as a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex, as one of the components of upper motor neuron syndrome [1].

BoNTA (botulinum toxin type A, onabotulinumtoxinA1) is a specific formulation of a locally injected muscle relaxant whose active ingredient is botulinum toxin type A produced by Clostridium botulinum. Botulinum toxin type A binds to the receptors in the presynaptic, cholinergic motor nerve terminal and is taken up by the nerve cells where the light chain of toxin cleaves a synaptosome-associated protein (SNAP-25) to inhibit acetylcholine release from the nerve terminal. As its muscle relaxant effect is exerted in the hypertonic muscle, BoNTA offers an alternative treatment for spastic patients who have difficulty with oral muscle relaxants that can produce generalized weakness and drowsiness, cognitive impairment, and/or a reduced level of arousal. Locally injected BoNTA is expected to improve limb position and functional ability, and reduce pain in patients with spasticity. Moreover, BoNTA has no sedative action, unlike existing oral antispastic treatments, and therefore can be used in patients with cognitive impairment or a reduced level of arousal. Based on these considerations, BoNTA is a first-line treatment choice if the upper and lower limb spasticity is focal and reversible without contracture [2].

The efficacy and safety of BoNTA in patients with post-stroke lower limb spasticity have been suggested by randomized-controlled trials of limited scale [345678] and meta-analysis [9]. The efficacy of BoNTA in patients with severe brain injury has also been demonstrated in a randomized-control trial [10]. Approved treatments of spasticity in Japan include peripheral and central muscle relaxants, alcohol, phenol block, and intrathecal baclofen (only in cases of severe spastic paralysis). We conducted a clinical study to evaluate the efficacy and safety of BoNTA in Japanese patients with post-stroke lower limb spasticity who received a single placebo-controlled injection of BoNTA followed by open-label repeated treatment of up to three sessions. This article reports the efficacy and safety results of the double-blind phase. […]

 

Continue —->  Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial | SpringerLink

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[Abstract] Botulinum toxin type A in post-stroke upper limb spasticity

Objective:

To evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke upper limb spasticity.

Research design and methods:

In a multicentre, randomised, double-blind, parallel-group, placebo-controlled study, 109 patients with upper limb spasticity were randomised to receive a single treatment with lower-dose (120–150 U) or higher-dose (200–240 U) BoNTA or placebo into upper limb muscles.

Main outcome measures:

The tone of the wrist flexor was assessed at baseline and at weeks 0, 1, 4, 6, 8 and 12 using the Modified Ashworth Scale (MAS) for wrist, finger, thumb and disability in activities of daily living (ADL) was rated using the 4-point Disability Assessment Scale (DAS). The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS wrist score in the higher-dose groups.

Results:

Subjects were randomised with 51 in the higher BoNTA group, 26 in the higher-dose placebo group, 21 in the lower BoNTA group and 11 in the lower-dose placebo group. Significant improvement in spasticity with higher-dose BoNTA was demonstrated by a mean difference in the AUC of the change from baseline in the MAS wrist score between the higher-dose BoNTA group and the higher-dose placebo group of −6.830 (p < 0.001, t-test), no significant different was demonstrated between the lower-dose BoNTA group and the lower-dose placebo group (p = 0.215, t-test). Significant improvements with higher-dose BoNTA were also observed in the DAS scores for limb position (p = 0.001–0.022) at all time points and dressing (p = 0.018–0.038, Wilcoxon test) at weeks 6, 8 and 12. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BoNTA-treated and placebo-treated patients. The long-term efficacy and safety, and the effects on rehabilitation of BoNTA on upper limb will be evaluated using the data obtained in the open-label phase.

Conclusions:

Higher-dose BoNTA reduced spasticity in upper limb muscles and improved ADL performance in terms of limb position and dressing. BoNTA is safe and effective in the treatment of post-stroke upper limb spasticity.

 

via Botulinum toxin type A in post-stroke upper limb spasticity: Current Medical Research and Opinion: Vol 26, No 8

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[Abstract] A smart brace to support spasticity management in post-stroke rehabilitation – Master Thesis

Abstract

This report covers the design of a product to help stroke survivors who are suffering from chronic spasticity manage their everyday activities. In the Netherlands alone, 44.000 people suffer from a Cerebro-Vascular Accident (CVA) each year. A CVA, more commonly known as a stroke, results in brain trauma with afflictions such as paralysis, fatigue and spasticity. It is possible to recover some, if not all, motor function though intensive physiotherapy, which requires long-term stay at a rehabilitation clinic in severe cases. Due to limited room and staff, only 12% of stroke survivors end up rehabilitating in a clinic. The remaining survivors are sent home, and will to travel to the clinic 3-5 times per week for therapy as part of the outpatient rehabilitation. Adjuvo Motion, a young start-up, aims to improve the situation of stroke survivors by bringing the rehabilitation centre to their home through the Adjuvo Platform, which allows them to perform exercises in the context of virtual tasks. They proposed an assignment to extend their product portfolio with a Range of Motion assessment device that is suited for those suffering from spasticity. Spasticity occurs in roughly 60% of stroke survivors with varying degrees of intensity. It is caused by the damaged parts of the brain sending conflicting signals to the muscles, causing them to contract. This inhibits the survivor’s ability to perform daily tasks, but can be solved temporarily with stretching exercises. A solution to compensate for these spastic forces using a passive-assist device was proposed at the start of this project. The project was divided into four stages: Analysis, Synthesis, Embodiment and Evaluation. During the Analysis stage, interviews with a Physiotherapist and stroke survivor and literature studies regarding anatomy, the state of the art and relevant technologies were used to create a framework for the design of a smart passive-assist glove. Looking at competing products, there is a demand for passive assist and Range of Motion assessment functionalities, yet a combination of these in a single device is not yet present in the market. During the Synthesis stage, the design problem of the passive assist device was split into three groups: Orthoses; the connections to the body, Passive Assist; the compensation medium, and RoM measurement; the sensing mechanism(s). These three groups were further split into sub-problems, the solutions to which were compiled into a Morphological Chart. By combining the solution within this chart, three promising concept designs were created: One upgrade to the existing sensor glove, one full integration of sensing and passive assist, and one passive assist glove with removeable sensors. To evaluate these concepts, eight criteria were established and weighted with the help of a physiotherapist. In order to create an objective assessment, the criteria were kept strictly quantitative and the three designs were first scored against the Raphael Smart Glove by Neofect using early prototypes. These scores were then used to evaluate the designs relative to each other, which resulted in an overall higher score for the concept with separable electronics. Making the sensor part of the brace removeable allowed the product to be used during daily life as well as physiotherpy exercises, and proved a key benefit in keeping the product clean. Based on the chosen design, four iterations of prototypes were made, which were tested with healthy subject. During this stage, it became clear that flex sensors are be best suited to create a range of motion assessment for spastic stroke patients, since it is less important to know how well they perform a task, and more important to know if they can actually perfrom it. Based on a quantified use case, the four sub-assemblies; the Wrist Wrap, Finger Modules and Sensor Module, and their connections were materialized in the Embodiment design stage. When selecting production methods, the main challenge was a small batch size of 1000 units, which made conventional techniques for mass production, such as Injection Molding, less attractive. This stage ended in an assesment of the product’s production price and durability: The product would cost €250 to make, and would last for 2.5 years before the Velcro connection on the Wrist Wrap would become too weak to sustain the spasticity forces. In the Evaluation stage, the product was evaluated on the seven most important requirements established during the analysis stage. For several of these, a user test was performed, again with healthy subject. While the Adjuvo Auxilius passed most theoretical requirements, the user tests on healthy subjects could not be used to draw any conclusions regarding its effectiveness on spastic stroke patients. However, since the product’s working principle is based on that of existing spasticity compensation products, the prediction is that the Auxilius will be an effective therapy supplement. The result of this project is the Adjuvo Auxilius; a spasticity-compensation glove with modular sensors, which can be added to allow virtual (stretching) exercises through the Adjuvo Motion’s platform. The results of these exercises are used to create a remote assessment of the patients motor skills, and to adjust the therapy if needed.

via A smart brace to support spasticity management in post-stroke rehabilitation | TU Delft Repositories

 

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[ARTICLE] Cost-Effectiveness of Treating Upper Limb Spasticity Due to Stroke with Botulinum Toxin Type A: Results from the Botulinum Toxin for the Upper Limb after Stroke (BoTULS) Trial – Full Text

Abstract

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.

1. Introduction

Stroke is a major cause of mortality and morbidity and imposes a significant burden on both health services and society [1,2,3]. In the United Kingdom (UK) it is estimated that the annual direct costs of stroke are approximately £4 billion, which constitutes around 5.5% of the total UK expenditure on health care [3]. If the costs of lost productivity and informal care are taken into account, the total annual societal costs of stroke are estimated to be around £9 billion [3]. In England, over 900,000 people are living with the consequences of stroke, 300,000 of whom are moderately or severely disabled [4]. As the proportion of older people in society increases, so the burden of stroke is likely to grow.

Upper limb spasticity after stroke is an important clinical problem and its identification and treatment are key components of stroke rehabilitation [5]. Upper limb spasticity may cause deformity, reduced function and pain [6]. Botulinum toxin type A, which when given by intramuscular injection causes temporary local muscle paresis by blocking neuromuscular transmission [7], has become an established treatment for spasticity due to stroke. Randomised controlled trials have shown that botulinum toxin reduces muscle tone [8] and improves the performance of basic upper limb functional tasks such as hand opening for cleaning and ease of dressing [9,10,11]. However, the impact on active upper limb function (e.g., reaching and grasping) and the efficacy of repeated treatment is less clear.

The BoTULS trial was a pragmatic multi-centre randomised controlled trial to evaluate the clinical and cost-effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. The clinical results indicated that botulinum toxin type A did not improve active upper limb function (as measured by the Action Research Arm Test (ARAT)), but that there may be benefits in terms of decreased muscle tone, improved upper limb strength, improved ease of performance of basic upper limb functional activities and reduction in pain [12]. This article describes the results of the cost-effectiveness analysis. […]

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[Abstract] Quantitative Ultrasound Imaging to Assess the Biceps Brachii Muscle in Chronic Post-Stroke Spasticity: Preliminary Observation

Abstract

We prospectively investigated the feasibility of using quantitative ultrasound imaging (QUI) to assess the biceps brachii muscle (BBM) in individuals with chronic post-stroke spasticity. To quantify muscle echogenicity and stiffness, we measured QUI parameters (gray-scale pixel value and shear wave velocity [SWV, m/s]) of the BBM in three groups: 16 healthy BBMs; 12 post-stroke, non-spastic BBMs; and 12 post-stroke, spastic BBMs. The QUI results were compared with the Modified Ashworth Scale and Tardieu Scale. A total of 20 SWVs were measured in each BBM, once at elbow in 90° flexion and again at maximally achievable extension using acoustic radiation force impulse imaging. BBM pixel value was measured in gray-scale images captured at 90° elbow flexion using ImageJ software. Statistical analyses included analysis of variance for examining the difference in SWV and pixel values among the three groups; Bonferroni correction for testing the difference in SWV and pixel values in a paired group; t-test for examining the difference in SWV values measured at two elbow angles; and Pearson correlation coefficient for analyzing the correlation of QUI to Modified Ashworth Scale and Tardieu Scale. SWV significantly differed between spastic BBMs and non-spastic or healthy BBMs. For pixel values, each of the three groups significantly differed from the others at elbow 90° flexion. The difference in SWV measured between the two elbow angles was also significant (p <0.01). A strong negative correlation was found between SWV and passive range of motion (R2 = −0.88, p <0.0001) in spastic upper limbs. These results suggest that the use of QUI is feasible in quantitative assessment of spastic BBM.

 

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[ARTICLE] Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial – Full Text

Abstract

Objective

To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A).

Design

post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299).

Setting

A total of 34 neurology or rehabilitation clinics in 9 countries.

Participants

Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n = 105 of 243 in the total trial population) in the affected limb. The mean age was 52 years, and 62% were male.

Intervention

Study subjects were randomized 1:1:1 to receive a single injection session with abobotulinumtoxinA 500 or 1000 U or with placebo in the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and ≥2 additional muscle groups from the upper limb.

Main Outcome Measurements

Efficacy and safety measures were assessed, including muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events.

Results

At week 4, more subjects had ≥1 grade improvement in MAS for the PTMG with abobotulinumtoxinA versus placebo (abobotulinumtoxinA 500 U, 81.1%; abobotulinumtoxinA 1000 U, 75.0%; placebo, 25.0%). PGA scores ≥1 were achieved by 75.7% and 87.5% of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7% with placebo. Perceived function (Disability Assessment Scale), spasticity angle (Tardieu Scale), and active movement were also improved with abobotulinumtoxinA. There were no treatment-related deaths or serious adverse events.

Conclusions

The efficacy and safety of abobotulinumtoxinA in subjects previously treated with BoNT-A were consistent with those in the total trial population. Hence, abobotulinumtoxinA is a treatment option in these patients, and no difference in initial dosing appears to be required compared to that in individuals not treated previously.

 

Introduction

Upper limb spasticity (ULS) is common after stroke or traumatic brain injury (TBI). The impact can be highly significant, including abnormal hand and arm positions, impaired self-care, and limited passive/active range of motion, as well as additional burden to the caregiver [1-5].

The effectiveness of treatment with intramuscularly injected botulinum toxin A (BoNT-A) in reducing muscle tone in patients with ULS is well established [5-8]. Several guidelines now recommend BoNT-A injections as a first-line treatment option in these patients [6,7,9-11].

AbobotulinumtoxinA (Dysport; Ipsen Biopharm, Wrexham, UK) is a BoNT-A preparation approved in the United States and Europe for the treatment of ULS in adult patients [12,13]. A recent clinical trial examined the efficacy and safety of a single injection session of abobotulinumtoxinA (500 or 1000 U) in 243 adults with ULS who had hemiparesis at least 6 months after stroke or TBI [14]. The effects observed included improvements in muscle tone, perceived function, spasticity, and active range of motion. Furthermore, the treatment was well tolerated, and all treatment-related adverse events (AEs) were mild or moderate in severity.

Among the subjects enrolled in this study, 105 had previously undergone treatment in the upper limb with onabotulinumtoxinA or incobotulinumtoxinA. The aim of the present analysis was to assess the efficacy and safety of abobotulinumtoxinA in adults with ULS who had been previously treated with a BoNT-A, and to describe the doses of abobotulinumtoxinA administered to these subjects. […]

Continue —> Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial – ScienceDirect

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[Abstract] Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomised placebo-controlled trial

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BACKGROUND: Spasticity is a common consequence of injury to the central nervous system negatively affecting patient’s everyday activities. Treatment mainly consists of training and different drugs, often with side effects. There is a need for treatment options that can be performed by the patient in their home environment.

AIM: The objective of this study was to assess the effectiveness of an assistive technology (AT), Mollii®, a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for self-treatment of spasticity, in study participants with spasticity due to stroke or CP.

DESIGN: The study was a randomised, controlled, double-blind study with a cross-over design.

SETTING: Participants were recruited from two rehabilitation clinics. Treatments were performed in participants’ homes and all follow-ups were performed in the two rehabilitation clinics.

POPULATION: Thirty-one participants were included in the study and 27 completed the study. Four participants discontinued the study. Two declined participation before baseline and two withdrew due to problems handling the garment.

METHODS: Participants used the AT with and without electrical stimulation (active/non-active period) for six weeks each, followed by six weeks without treatment. Goal Attainment Scaling (GAS), change in mobility, arm-hand ability, spasticity and pain were measured at baseline and after six, 12 and 18 weeks.

RESULTS: Fifteen of the 27 participants fulfilled the treatment protocol in terms of recommended use. Deviations were frequent. No statistically significant differences in outcome were found between the active and the non-active treatment periods. During the active period, an improvement was seen in the 10-metre comfortable gait test, time and steps. An improvement was seen in both the active and non-active periods for the GAS.

CONCLUSIONS: Compliance was low, partly due to deviations related to the garment, complicating the interpretation of the results. Further research should focus on identifying the target population and concomitant rehabilitation strategies.

CLINICAL REHABILITATION IMPACT: The evaluated concept of multifocal transcutaneous electrical stimulation (TES) represents an interesting addition to the existing repertoire of treatments to alleviate muscle spasticity. The evaluated concept allows TES to be self-administered by the patient in the home environment. A more elaborate design of training activities directly related to patient´s own rehabilitation goals is recommended and may increase the value of the evaluated concept.

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via Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomised placebo-controlled trial – European Journal of Physical and Rehabilitation Medicine 2017 Oct 25 – Minerva Medica – Journals

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[Abstract] Interventions for managing skeletal muscle spasticity following traumatic brain injury – Cochrane Systematic Review

Abstract

Background

Skeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI.

Objectives

To assess the effects of interventions for managing skeletal muscle spasticity in people with TBI.

Search methods

In June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies.

Selection criteria

We included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life).

Data collection and analysis

We used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data.

Main results

We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.

Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.

It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes.

Authors’ conclusions

The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.

Plain language summary

Treatments for spasticity (overactive muscle contractions) following brain injury

Review question

We reviewed the evidence about the effect of treatments (drug and non-drug) for spasticity following a brain injury caused by a blow to the head (traumatic brain injury (TBI)).

Background

Many people with TBI experience muscle spasticity, when their muscles contract or tighten involuntarily. This can impact on a person’s ability to carry out daily activities causing pain, stiffness and broken skin. There are many treatments used to manage spasticity, including medicines, casting, splints and stretches. Often, these treatments are used in combination.

Study characteristics

We included nine studies in this review which involved 134 participants with TBI. Only five studies, including 105 people provided usable results. These studies tested the effects of a range of treatments, including medicines (baclofen or botulinum toxin A), casting, physiotherapy, splints, a table that moves people from the lying position to standing and electrical stimulation (where electrical impulses are delivered to the muscles). Studies inadequately reporting results had tested the effect of medicines (baclofen or tizanidine).

Study funding sources

Of the five studies with results, three were funded by governments, charities or health services and two were funded by a drug manufacturer and medical technology company. The other four studies without useable results were funded by drug manufacturer or medical technology companies.

Key results

This evidence is current to June 2017.

Interpreting the results of the studies was difficult because of a lack of information and concerns about the quality of the evidence. For spasticity, some studies concluded that the treatment they tested made an improvement, and others found no difference between treatments. The most common side effect was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all measurements.

Quality of the evidence

The quality of this evidence was very low; we only had five studies with results and none of the studies were large or comparable with one another. We also had concerns about how they were conducted or analysed. Because of this, we cannot draw any firm conclusions about the benefits and harms of different treatments for spasticity in people with TBI.

via Interventions for managing skeletal muscle spasticity following traumatic brain injury – Synnot – 2017 – The Cochrane Library – Wiley Online Library

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