Adult Spasticity Research Articles

Dose-Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study

BackgroundAbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. ObjectiveTo describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DesignSecondary analysis of a phase 3 study (NCT01313299). SettingMulticenter, international, double-blind, placebo-controlled clinical trial. ParticipantsA total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose). MethodsThe overall effects of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects. Main Outcome MeasuresAngle of arrest (XV1) and angle of catch (XV3) were assessed with the Tardieu Scale, and active range of motion (XA). ResultsAt each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (XV1, XV3, XA) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in XV3 and XA, suggesting a dose-dependent effect. ConclusionsPrevious clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints. Level of EvidenceI

Efficacy of IncobotulinumtoxinA in Treatment of Lower Limb Spasticity in Adults (P4.035)

Efficacy of IncobotulinumtoxinA in Treatment of Lower Limb Spasticity in Adults (P4.035)

OnabotulinumtoxinA for Lower Limb Spasticity: Guidance From a Delphi Panel Approach

BackgroundOnabotulinumtoxinA is approved for the treatment of upper and lower limb spasticity in adults. Guidance on common postures and onabotulinumtoxinA injection paradigms for upper limb spasticity has been developed via a Delphi Panel; however, similar guidance for lower limb spasticity has not been established. ObjectiveTo define a clinically recommended treatment paradigm for the use of onabotulinumtoxinA for each common posture among patients with poststroke lower limb spasticity (PSLLS) and to identify the most common PSLLS aggregate postures. DesignClinical experts provided insight regarding onabotulinumtoxinA treatment for PSLLS using an adaptation of the Delphi consensus process. SettingDelphi panel. ParticipantsTen expert clinicians in neurology and physical medicine and rehabilitation who treat PSLLS. MethodsA minimum of 2 rounds of anonymous voting occurred for each recommendation until consensus was reached (≥66% agreement). The first round was conducted via a survey; the second round was an in-person meeting. Main Outcome MeasurementsReached consensus on muscle selection for injection, overall and per-muscle dose of onabotulinumtoxinA, number of injection sites/muscle, onabotulinumtoxinA dilution, and use of localization techniques. The most common PSLLS postures were reviewed. Recommendations were tailored toward injectors with less experience. ResultsConsensus was reached on targeted subsets of muscles for each posture. Doses ranged from 20 to 150 U for individual muscles and 50 to 300 U for limb postures. OnabotulinumtoxinA dilution 50 U/mL (2:1 ratio) was considered most appropriate but varied based on muscles selected (range, 2:1-4:1). Experts agreed that localization techniques for muscle identification during injection for all postures would be useful. For suboptimal response to injection, all panel members would increase the dose, and the majority (89%) would increase the number of treated muscles. The panel identified 3 common aggregating lower limb postures: (1) equinovarus foot and flexed toes; (2) extended knee and plantar flexed foot/ankle; and (3) plantar flexed foot/ankle and flexed toes. The recommended starting doses for each aggregate posture were 400 U, 400 U, and 300 U, respectively. ConclusionThe modified Delphi panel process provided consensus on common muscles and corresponding onabotulinumtoxinA treatment paradigms for postures associated with PSLLS that can be used for guidance in optimizing care delivery. Level of EvidenceV

Adult Spasticity International Registry Study: methodology and baseline patient, healthcare provider, and caregiver characteristics.

The main aim of this study was to determine the utilization patterns and effectiveness of onabotulinumtoxinA (Botox®) for treatment of spasticity in clinical practice. An international, multicentre, prospective, observational study at selected sites in North America, Europe, and Asia. Adult patients with newly diagnosed or established focal spasticity, including those who had previously received treatment with onabotulinum-toxin A. Patients were treated with onabotulinumtoxinA, approximately every 12 weeks, according to their physician's usual clinical practice over a period of up to 96 weeks, with a final follow-up interview at 108 weeks. Patient, physician and caregiver data were collected. Baseline characteristics are reported. Of the 745 patients enrolled by 75 healthcare providers from 54 sites, 474 patients had previously received onabotulinumtoxinA treatment for spasticity. Lower limb spasticity was more common than upper limb spasticity, with stroke the most common underlying aetiology. The Short-Form 12 (SF-12) health survey scores showed that patients' spasticity had a greater perceived impact on physical rather than mental aspects. The data collected in this study will guide the development of administration strategies to optimize the effectiveness of onabotulinumtoxinA in the management of spasticity of various underlying aetiologies.

PND4 - Real-World Outcomes and Resource Utilisation Following Onabotulinumtoxina Treatment For Severe Lower Limb Focal Spasticity in Adults – Database Analysis at An Australian Hypertonicity Clinic

PND4 - Real-World Outcomes and Resource Utilisation Following Onabotulinumtoxina Treatment For Severe Lower Limb Focal Spasticity in Adults – Database Analysis at An Australian Hypertonicity Clinic

Clinical commentary: Systemic and subclinical adverse effects of repeated botulinum toxin a injections to decrease spasticity in adults affected by stroke undergoing rehabilitation

This is a clinical commentary that expands on an initial attempt to classify possible adverse effects (AE) of repeated and long-term use of Botox A (BTX) to manage post-stroke spasticity into three types, local, systemic and subclinical AE

Poster 203 Systematic Literature Review of AbobotulinumtoxinA in Randomized, Controlled Clinical Trials for Adult Lower Limb Spasticity.

Poster 203 Systematic Literature Review of AbobotulinumtoxinA in Randomized, Controlled Clinical Trials for Adult Lower Limb Spasticity.

Poster 496 Budget Impact Analysis of Botulinum Toxin A Therapy for Adult Upper Limb Spasticity in the United States

Poster 496 Budget Impact Analysis of Botulinum Toxin A Therapy for Adult Upper Limb Spasticity in the United States

Poster 281 The Adult Spasticity International Registry (ASPIRE Study): Baseline Demographics and Clinical Characteristics of Patients Treated for Spasticity

Poster 281 The Adult Spasticity International Registry (ASPIRE Study): Baseline Demographics and Clinical Characteristics of Patients Treated for Spasticity

AAN Issues New Guideline for Botulinum Neurotoxin for Blepharospasm, Cervical Dystonia, Adult Spasticity, and Headache

AAN Issues New Guideline for Botulinum Neurotoxin for Blepharospasm, Cervical Dystonia, Adult Spasticity, and Headache

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology.

To update the 2008 American Academy of Neurology (AAN) guidelines regarding botulinum neurotoxin for blepharospasm, cervical dystonia (CD), headache, and adult spasticity. We searched the literature for relevant articles and classified them using 2004 AAN criteria. Blepharospasm: OnabotulinumtoxinA (onaBoNT-A) and incobotulinumtoxinA (incoBoNT-A) are probably effective and should be considered (Level B). AbobotulinumtoxinA (aboBoNT-A) is possibly effective and may be considered (Level C). CD: AboBoNT-A and rimabotulinumtoxinB (rimaBoNT-B) are established as effective and should be offered (Level A), and onaBoNT-A and incoBoNT-A are probably effective and should be considered (Level B). Adult spasticity: AboBoNT-A, incoBoNT-A, and onaBoNT-A are established as effective and should be offered (Level A), and rimaBoNT-B is probably effective and should be considered (Level B), for upper limb spasticity. AboBoNT-A and onaBoNT-A are established as effective and should be offered (Level A) for lower-limb spasticity. Headache: OnaBoNT-A is established as effective and should be offered to increase headache-free days (Level A) and is probably effective and should be considered to improve health-related quality of life (Level B) in chronic migraine. OnaBoNT-A is established as ineffective and should not be offered for episodic migraine (Level A) and is probably ineffective for chronic tension-type headaches (Level B).

Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Payment policy perspectives.

This article is presented as a companion to the American Academy of Neurology guideline update on the use of botulinum neurotoxin (BoNT) for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Whereas the guideline update provides clarity on the efficacy of different BoNT-branded preparations for the 4 listed indications, this companion piece identifies ambiguities in the evidence for efficacy among various brand names for a given clinical indication, their dosing equivalencies, as well as different clinical indications. This article provides guidance and background information to reduce obstacles for third party payment, especially when uncertainties exist and levels of evidence are lower.

Botulinum toxins in clinical practice: Gaps in knowledge.

Since the first clinical use of botulinum toxins over a quarter of a century ago, they have proven themselves a versatile tool, especially in the fields of movement disorders and rehabilitation medicine. A practice guideline update on botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache has recently been published in Neurology ®.1

Baseline Demographics and Clinical Characteristics of Patients Treated for Spasticity in the Adult Spasticity International Registry (ASPIRE Study) (P3.296)

Baseline Demographics and Clinical Characteristics of Patients Treated for Spasticity in the Adult Spasticity International Registry (ASPIRE Study) (P3.296)

Botulinum Toxin Treatment of Spasticity in Adults and Children.

Spasticity is a frequent symptom in stroke, multiple sclerosis, cerebral or spinal trauma, and cerebral palsy that affects and disables a large number of adults and children. In this review, we discuss the pathophysiology and nonpharmacologic and pharmacologic treatments of spasticity with emphasis on the role of botulinum neurotoxins (BoNTs). The world literature is reviewed on double-blind and placebo-controlled clinical trials reporting safety and efficacy of BoNT treatment in adult spasticity and spasticity of children with cerebral palsy. The evidence for efficacy is presented from recommendations of the Assessment and Therapeutics subcommittee of the American Academy of Neurology. A technical section describes the techniques and recommended doses of BoNTs in spasticity.

More than a black box of rehabilitation: Characterizing therapy programmes following botulinum toxin injections for spasticity in adults with stroke.

To describe ambulatory rehabilitation programmes (physical and occupational therapy activities and interventions) following botulinum toxin injections for post-stroke spasticity using a stroke rehabilitation taxonomy. To explore the relationship between therapy provided and injected limb/s and treatment goals. Prospective, observational cohort study. Stroke survivors (n = 47) participating in ambulatory rehabilitation programmes following botulinum toxin injections for upper limb, lower limb or upper and lower limb spasticity. Standardized therapy documentation forms were completed prospectively for each occupational and physical therapy session. Main outcomes were the proportion of total therapy time spent in various therapeutic activities; total sessions during which each intervention was used to facilitate the activities most time was spent in; and goals related to each activity category. Sub-analysis was carried out for participants, based on limb/s injected. Most time was spent in "upper extremity control" activities as the upper limb was more often injected. A large proportion of therapy time was spent in activities remediating "performance skills or body structure and function impairments". In the upper and lower limb, and upper limb groups 38.7% and 46.2% of goals, respectively, related to this activity category, but less than 10% in the lower limb group. Little time was spent in community participation and leisure activities, whilst over one-third of lower limb group goals related to this category. Ambulatory rehabilitation programmes following botulinum toxin injections for post-stroke spasticity varied depending on limb/s injected and reflected treatment goals to some extent.

A completed audit loop of a botulinum toxin therapy service for adult spasticity

Aims: To undertake a re-audit of all process standards relating to a multidisciplinary team spasticity service employing botulinum toxin set up in 2008, and to identify and clarify the effectiveness of the referral pathway for this service. Methods: A retrospective sample of 100 consecutive adult patient case notes who were treated with botulinum toxin and seen by the multidisciplinary team. This audit used the national guidelines set out by the Royal College of Physicians et al (2009) as the gold standard. Results: Participants (n=100; mean age=63.5 years; age range 17–86 years) had a variety of diagnoses but predominantly ischaemic stroke. Comparison of audit and re-audit data demonstrated significant improvements in 17 out of 19 service standards, which included patients reviewed by consultant, multidisciplinary team assessment, and achievement of patient goals and functional abilities. Conclusions: This iterative process provides practice-based evidence of the benefit of identifying the post-injection therapist prior to the injection of botulinum toxin. This re-audit also enabled further improvement of service re-design in order to reduce waiting times in future.

Effects of Isokinetic Exercise on Hip Extensor and Flexor Strength, Gait Speed and Spasticity in Adults with Stroke

Effects of Isokinetic Exercise on Hip Extensor and Flexor Strength, Gait Speed and Spasticity in Adults with Stroke

Impact of injection-guiding techniques on the effectiveness of botulinum toxin for the treatment of focal spasticity and dystonia: A systematic review

To conduct a systematic review of the impact of different injection-guiding techniques on the effectiveness of BoNT-A for the treatment of focal spasticity and dystonia. Articles were identified through a comprehensive search of the following computerized databases: MEDLINE via Pubmed, Academic Search Premier, Pascal, the Cochrane Library, Scopus, SpringerLink, Web of Science, EM Premium and PsychINFO. Two reviewers (AG and MD) independently selected potential studies based on pre-determined inclusion criteria. The main data were extracted. Methodological quality was graded independently by 2 reviewers using the Physiotherapy Evidence Database (PEDro) assessment scale for randomized controlled trials (RCTs) and the Downs and Black (D&B) evaluation tool for non-RCTs. Level of evidence was determined using the modified Sackett scale. Ten studies were included. Seven were randomized. There was strong evidence (Level 1) that instrumented guiding (Ultrasound [US], Electrical-stimulation [ES], Electromyography [EMG]) was more effective than manual needle placement for the treatment of spasmodic torticollis, upper limb spasticity and spastic equinus in patients with stroke and spastic equinus in children with cerebral palsy. A few studies provided strong evidence (Level 1) of similar effectiveness of US and ES for upper and lower limb spasticity in patients with stroke and spastic equinus in children with cerebral palsy, but there was poor evidence or no evidence available for EMG or other instrumented techniques. These results strongly recommend the use of instrumented guiding techniques for BoNT-A injection for the treatment of spasticity in adults and children (ES or US) and of focal dystonia such as spasmodic torticollis (EMG). No specific recommendations can be made regarding the choice of instrumented guiding techniques.

Quantifying patterns of upper limb motor change following BTX-A injection in adult spasticity management

Objective: To evaluate the capacity of the Upper Limb Performance Analysis: Comparative Analysis of Performance-Motor (CAP-M) to quantify change in adults with focal spasticity following injection of Botulinum Toxin-A (BTX-A) as a focal treatment for positive Upper Motor Neuron (UMN) features.Methods: Twenty-three adults with moderate-to-severe spasticity were assessed pre- and post-BTX-A injection using CAP-M. Post-hoc video analysis of three sub-tests from the Action Research Arm Test were analysed against expected movements for each task.Results: Post-injection, spasticity as measured by Modified Ashworth and Tardieu Composite scores decreased significantly (p < 0.001). Grouped CAP-M data showed a significant reduction (z = 2.1–2.7, ES = 0.51–0.56) in positive UMN features, with 145 fewer Excessive movements recorded. In addition, 31 more Expected movements were demonstrated (z = 2.9, ES = 0.60), consistent with ‘unmasking’ of movements.Conclusion: CAP-M analysis revealed that BTX-A injection decreased unwanted movement almost 5-times more frequently than ‘unmasking’ hidden voluntary muscle activity during active simulated tasks. In this way, CAP-M was able to simultaneously assess positive and negative UMN features. This quantitative framework may have greater functional relevance than traditional uni-dimensional, passive spasticity measures such as MAS and Tardieu Scale.