Treatment Of Lower Limb Spasticity Research Articles

Leg Activity Measure (LegA) Sensitivity to Change Following Treatment of Lower Limb Spasticity with a Single Cycle of AbobotulinumtoxinA in an Ambulatory Population

Leg Activity Measure (LegA) Sensitivity to Change Following Treatment of Lower Limb Spasticity with a Single Cycle of AbobotulinumtoxinA in an Ambulatory Population

Leg Activity Measure (LegA) sensitivity to change following treatment of lower limb spasticity with a single cycle of abobotulinumtoxinA in an ambulant population (P12-8.010)

Leg Activity Measure (LegA) sensitivity to change following treatment of lower limb spasticity with a single cycle of abobotulinumtoxinA in an ambulant population (P12-8.010)

A Virtual Reality Platform to Facilitate Training on Treatment of Lower Limb Spasticity With OnabotulinumtoxinA

<h3>Research Objectives</h3> To assess the benefits of a virtual reality (VR)–based training platform. <h3>Design</h3> A VR-based platform employing an immersive experience with haptic technology was designed to provide training on the use of onabotulinumtoxinA for lower limb spasticity (LLS) to increase treatment consistency and enhance knowledge and injection competency.1-5 In a pilot program (December 2020–August 2021), participants underwent one-on-one training on lower limb anatomy and injection guidance, then assessed the platform by completing pre- and post-training surveys. <h3>Setting</h3> Twenty-one US-based academic centers. <h3>Participants</h3> Medical trainees. <h3>Interventions</h3> Not applicable. <h3>Main Outcome Measures</h3> Knowledge gap on the treatment of LLS using pre–VR-training and post–VR-training surveys. <h3>Results</h3> Six medical students, 124 residents, and 10 fellows completed pre−VR-training surveys; 111 completed post−VR-training surveys. Average learning time per VR session was ∼43 minutes. The percentage of participants who were very comfortable with localization of lower limb muscles increased from 8% pre−VR-training to 14% post−VR-training. Percentages of participants identifying all correct responses almost doubled from pre−VR-training to post−VR-training when asked about possible functions of the flexor digitorum longus (12% vs 22%) and what muscles to consider injecting in a hypothetical poststroke patient (21% vs 40%). Pre−VR-training, 46% and 34% of participants indicated that a VR-based training tool would be very or extremely useful, respectively; post−VR-training responses were 33% and 52%, respectively. Top features participants found beneficial were the realistic feel of needle insertion/removal (82%) and the ability to use injection guidance (79%). <h3>Conclusions</h3> Preliminary results suggest medical trainees have incomplete baseline knowledge and the potential need for additional training experience, for which VR may be useful. VR training duration and additional interventions to optimize training need to be defined. <h3>Author(s) Disclosures</h3> EM: Speaker: AbbVie. SAD: Investigator: AbbVie; Consultant: Allergan (an AbbVie company). AE: Consultant: Allergan, (an AbbVie company), Ipsen, Merz; Research grants: Allergan (an AbbVie company), Ipsen. GEF: Consultant for, research grants from: Allergan (an AbbVie company), Ipsen, Merz. MV-G: Consultant/Speaker: AbbVie, Ipsen, Merz. KI, ACB, GP: Employee: AbbVie. AB: Employee: AbbVie at study conduct. NK: Consultant/Speaker: AbbVie.

The impact of intrathecal baclofen on the ability to walk: A systematic review

Objective Intrathecal baclofen (ITB) is an effective treatment for lower limb spasticity. In ambulatory patients with spasticity, there is a justifiable concern that ITB treatment may compromise ambulatory function by reducing the heightened muscle tone, thereby unmasking underlying muscle weakness. ITB is hence offered with reservation in ambulant patients. In this article, we review the literature surrounding the effect of ITB therapy on ambulatory function in patients with concurrent spasticity and discuss the key findings. Data sources A literature search of ProQuest Medline and EBSCO CINAHL databases was performed. Review method Inclusion criteria included (a) studies reporting the effect of ITB in adult ambulatory patients; (b) studies with an intervention of screening test trial via either bolus injections or continuous infusion tests; and (c) studies with an intervention of ITB pump implantation. Seventeen eligible studies were identified and two authors independently assessed the study quality using the risk of bias in nonrandomised studies of interventions tool (ROBINS-I). Results Seventeen studies were included, with a total of 534 participants. Most of the patients remain ambulatory after ITB treatment, accompanied by improvements in gait speed and reduction in spasticity. Conclusion ITB therapy when administered in carefully selected ambulatory patients with spasticity is not associated with loss of ambulatory function.

A Virtual Reality Platform to Facilitate Training on Treatment of Lower Limb Spasticity With OnabotulinumtoxinA

A Virtual Reality Platform to Facilitate Training on Treatment of Lower Limb Spasticity With OnabotulinumtoxinA

A Virtual Reality Platform to Facilitate Training on Treatment of Lower Limb Spasticity With OnabotulinumtoxinA (S32.003)

A Virtual Reality Platform to Facilitate Training on Treatment of Lower Limb Spasticity With OnabotulinumtoxinA (S32.003)

Baseline presentation and goal setting for patients undergoing treatment for lower limb spasticity with abobotulinumtoxinA in routine practice. Data from the AboLiSh study (S10.003)

Baseline presentation and goal setting for patients undergoing treatment for lower limb spasticity with abobotulinumtoxinA in routine practice. Data from the AboLiSh study (S10.003)

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects.

ObjectiveTo confirm the efficacy and safety of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH; total dose 400 U) in Japanese subjects with lower limb (LL) poststroke spasticity using the Modified Ashworth Scale spasticity score for the plantar flexors (MAS-PF).MethodsThis phase III study (Japic clinical study database No. CTI-153030, 7 October 2015) included a double-blind, 12-week main period (MP) in which 208 subjects were randomized to receive one injection cycle of incobotulinumtoxinA 400 U (n = 104) or placebo (n = 104) in the pes equinus muscles, and an open-label extension (OLEX) that enrolled 202 subjects who received three injection cycles, 10–14 weeks in duration (the last cycle was fixed at 12 weeks). Changes in MAS-PF for incobotulinumtoxinA vs. placebo from baseline to Week 4 of the MP and to the end-of-cycle visits in the OLEX were evaluated.ResultsThe area under the curve for the change in MAS-PF was statistically significantly greater with incobotulinumtoxinA vs. placebo in the MP (mean: −7.74 vs. −4.76; least squares mean: −8.40 vs. −5.81 [p = 0.0041]). In the OLEX, mean changes in MAS-PF from baseline to end-of-study showed continued improvement with repeated injections. No new safety concerns were observed with the incobotulinumtoxinA treatment. Its efficacy and safety were consistent regardless of the length of the injection cycle interval in the OLEX.ConclusionThis study demonstrated that incobotulinumtoxinA (total dose 400 U) is an effective and a well-tolerated treatment for LL spasticity in Japanese subjects using flexible injection intervals of 10–14 weeks.

Goal Attainment: A Clinically Meaningful Measure of Success of Botulinum Toxin-A Treatment for Lower Limb Spasticity in Ambulatory Patients

ObjectivesThe objectives of this study were to evaluate whether botulinum toxin type A (BoNT-A) treatment for lower limb spasticity leads to patient goal attainment and identify factors associated with positive goal attainment and to assess the effect of BoNT-A treatment on patients’ gait. DesignRetrospective cohort study between June 2014 and February 2019. SettingPublic outpatient spasticity clinic in a tertiary hospital. ParticipantsThirty patients (N=30; 50% female; average age, 50.5y) with lower limb spasticity of heterogenous etiologies (96.7% cerebral±spinal origin and 3.3% isolated spinal origin); 73.3% (N=22) of patients had previously received BoNT-A treatment. InterventionsBoNT-A injection to lower limb muscles. Main Outcome MeasuresThe primary outcome measure was goal attainment measured using Goal Attainment Scaling. The Modified Ashworth Scale (MAS) was used to assess spasticity. Gait was characterized by spatiotemporal parameters. ResultsFifty-six treatment episodes were analyzed and showed that BoNT-A treatment resulted in a significant reduction in spasticity (pretreatment MAS=3.18±0.73; posttreatment MAS=2.27±0.89; P<.001) with no associated change in gait parameters. Logistic regression revealed that most patients (74.1%) achieved all of their goals, with younger patients having a high likelihood of goal attainment regardless of their gait profile identified by latent profile analysis of the gait parameters. Patients considered to have a low functioning gait profile demonstrated a significantly greater likelihood of goal attainment than patients with the other gait profiles combined (odds ratio, 45.6; 95% confidence interval, 1.3-1602.1; P=.036). Chronic spasticity and pretreatment severity of spasticity (MAS) and its reduction were not associated with likelihood of goal attainment. ConclusionsThe success and efficacy of BoNT-A treatment in improving patient perceived gait quality and reducing the negative symptoms of spasticity were best measured using Goal Attainment Scaling. The study emphasizes the importance of measuring patient goals as a clinical outcome. Gait parameters were most informative when used collectively to classify patients based on their overall gait profile, which assisted in identifying differences between patients’ likelihood of goal attainment after treatment.

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects (1287)

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects (1287)

Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity.

IntroductionOnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals.ObjectiveTo explore real‐world onabotulinumtoxinA utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study.DesignTwo‐year, multicenter, prospective, observational registry (NCT01930786).SettingFifty‐four international clinical sites.PatientsAdults (naïve or non‐naïve to botulinum toxin[s] treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome.InterventionsOnabotulinumtoxinA administered at the clinician's discretion.Main Outcome MeasuresOnabotulinumtoxinA treatment utilization, clinician‐ and patient‐reported satisfaction.ResultsIn ASPIRE, 530 patients received ≥1 onabotulinumtoxinA treatment for lower limb spasticity (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot was treated most often (80.9% of patients), followed by flexed knee (26.0%), stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was most commonly used for injection localization (≥41.1% of treatment sessions). Despite low patient response on the satisfaction questionnaire, clinicians (94.6% of treatment sessions) and patients (84.5%) reported satisfaction/extreme satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. These data should be interpreted with care. Twenty‐one adverse events (AEs) in 18 patients (3.4%) were considered treatment‐related. Sixty‐seven patients (12.6%) reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered treatment‐related. No new safety signals were identified.ConclusionsASPIRE provides long‐term observational data on the treatment of lower limb spasticity with onabotulinumtoxinA. Real‐world data from this primary analysis can help to guide the clinical use of onabotulinumtoxinA to improve spasticity management.

Efficacy and safety of incobotulinumtoxinA in the treatment of lower-limb spasticity in adults: The pattern customized study design

Efficacy and safety of incobotulinumtoxinA in the treatment of lower-limb spasticity in adults: The pattern customized study design

Efficacy and safety of incobotulinumtoxinA in the treatment of lower-limb spasticity in Japanese patients

Efficacy and safety of incobotulinumtoxinA in the treatment of lower-limb spasticity in Japanese patients

Sustained efficacy of incobotulinumtoxinA over 6 injection cycles for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy

Sustained efficacy of incobotulinumtoxinA over 6 injection cycles for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy

Efficacy and safety of IncobotulinumtoxinA in the treatment of lower limb spasticity in Japanese subjects

Objective: To confirm the efficacy and safety of botulinum toxin type A (BoNT-A) treatment incobotulinumtoxinA (INCO; Xeomin®, Merz Pharmaceuticals GmbH) in Japanese subjects from study sites in Japan with post-stroke spasticity in the lower limb (LL), using the Modified Ashworth Scale (MAS) spasticity score for the plantar flexors.

Botulinum toxin type A in the treatment of lower limb spasticity in children with cerebral palsy.

We evaluated the safety and effectiveness of botulinum toxin A (BoNT/A) in the treatment of spasticity in 20 children with spastic diplegic cerebral palsy (CP). All the patients received injections in the gastrocnemius and soleus, and 15 received injections in the adductors. The total dose varied from 70 to 140 U (99.75±16.26 U), or 7.45 ±2.06 U/kg per patient. The treatment improved the patients' walking and gait pattern significantly. There was also a significant alteration in the heel-ground distance and increased motion of the ankle joint. These structural changes in the feet were sustained until the end of the follow-up, although the same was not observed for the functional parameters. Three patients complained of weakness in the lower limbs. In conclusion, BoNT/A is safe and effective when used in a single session of injections and produces a sustained structural modification of the lower limbs. However, functional changes are temporary and are only observed during the peak effect of the drug.

Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

Individualized OnabotulinumtoxinA Treatment for Lower Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE Study (P4.8-026)

Individualized OnabotulinumtoxinA Treatment for Lower Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE Study (P4.8-026)

The use of combination therapy in the treatment of lower limb spasticity among patients after stroke - a review of literature

Stroke is not only a medical problem, but also, due to the permanent disability of patients, a significant social issue. Therefore, gait disturbances resulting from lower limb muscle spastici-ty are a common subject of research. The ambiguities in the scientific literature have become justification for the creation of this systematic review, the aim of which is to collect and ana-lyse works describing the efficacy of combination therapy - including Botulinum toxin type A injections and physiotherapy following stroke. The following databases were searched: Pub-Med, EBSCO, Springer Link (date of access: 24 Jan. 2019). It was assumed that analysis will include scientific works published in English from 2000 to date (in accordance with search date). For the entry "combination therapy" (Botulinum toxin injections and physiotherapy), the search was conducted using the following keywords: physical therapy, Botulinum toxin type A, Botox A, lower limb, gait, brain, stroke, hemiparesis. Out of all the elaborate articles, 7 concerning combination therapy were ultimately evaluated. Analysis of the collected works indicates the effectiveness of combination therapy in the area of improving structural parame-ters. Some of the works prove that this type of therapy also improves functional indices and leads to increased activity of patients. We could not collect satisfactory evidence confirming its effectiveness in terms of increasing social participation and improving the quality of life of patients. This review indicates the need to develop specific therapeutic protocols accurately describing both Botulinum toxin injections and physiotherapy - taking the intensity, duration and type of therapy into account. Opoka K., Filip M., Mirek E., Pasiut S. The use of combination therapy in the treatment of lower limb spasticity among patients after stroke − a review of literature. Med Rehabil 2019; 23(2): 36-41. DOI: 10.5604/01.3001.0013.0875 This article is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License CC BY-SA (http://creativecommons.org/licenses/by-sa/4.0/) null

Botulinum Toxin Type A for the Treatment of Lower Limb Spasticity after Stroke.

Post-stroke lower limb spasticity impairs balance and gait leading to reduced walking speed, often increasing wheelchair use and caregiver burden. Several studies have shown that appropriate treatments for lower limb spasticity after stroke include injections of botulinum toxin type A (BoNT-A), phenol or alcohol, surgical correction and a rehabilitation program. In the present article, we review the safety and effectiveness of BoNT-A for the treatment of lower limb spasticity after stroke, with a focus on higher doses of BoNT-A. The cumulative body of evidence coming from the randomized clinical trials and open-label studies selected in the article suggest BoNT-A to be safe and efficacious in reducing lower limb spasticity after stroke. Studies of high doses of BoNT-A also showed a greater reduction of severe post-stroke spasticity. In stroke survivors with spasticity of the ankle plantar-flexor muscles, a combined approach between surgery and BoNT-A can be indicated. However, controversy remains about improvement in motor function relative to post-stroke spasticity reduction after BoNT-A treatment.