Active clinical trials for "Muscle Spasticity"

Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy). Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.

This is a research study aiming to identify imaging biomarkers in patients diagnosed with spastic paraplegia type 5 (SPG5)

This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.

The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).

To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.

Spasticity is a disorder of the muscular tonus that occurs in disease including the upper motor neuron (strokes, spinal cord injuries, multiple sclerosis, traumatic brain injuries or cerebral palsies). It begins few hours after the neural aggression and last until the grave. The most accepted definition refers to a velocity-dependent increase in stretch reflexes elicited by passive stretch (Lance definition) but new approaches prefers to distinguish neural (reflex) and non-neural (soft tissues alterations) components of the increase resistance to a passive stretch. This deficiency is a major cause of complications as walking impairment, pain or bone deformities and may require intensive therapies (intrathecal baclofen infusion, intramuscular toxin botulinium injection, surgery, etc). Despite its high frequency and the potential complications, only clinical scales (modified Ashworth scale and modified Tardieu scale essentially) with criticized metrological properties are available for daily assessment. The SPASM Consortium has published on 2005 recommendations for developing devices using both mechanical and electrophysiological parameters. The principle challenge was to ally parameters accuracy and utilization facility allowing quickly evaluation to the patient's bed. Few research team works on this topic but mostly on specific population and nowadays, no device has really crossed the door of laboratories. This kind of tool would help us to improve the quality of the follow-up and to guide us between the choices of specific therapies. The MSPMI has been created following these recommendations in the University of Technology of Compiègne, thanks to the collaboration between researchers of the UMR 7338 CNRS and a brain surgeon of the Nantes University Hospital. The patent was obtained on 2012. This device allows the assessment of the ankle plantar extensor (triceps surae) during a manually applied stretch movement. This muscle was selected as it is frequently involved and treated for spasticity. This study aims to evaluate the metrological properties of the MSPMI (reliabilities, responsiveness, known group validity, construct validity, measurement errors and internal consistency) among a large cohort of patients with no restriction of etiologies recruited in the Nantes University Hospital.

A high number of patient with stroke develops spasticity of the upper extremity, this clinical sign of damage of 1 motoneuro (MN), causes postures and patterns of abnormal movement, due to the hyperexcitability of the MN and the rheological alterations that occur in the affected muscles. These alterations limit the use of upper extremity, restricting its use in functional activities and affecting the quality of life and social participation of the users. During the last few years the classification of the Hefter patterns for spasticity of the upper limb was created, with the end of having a common language and orienting the current therapeutic strategies oriented towards the arm. Objective: To determine the prevalence of patterns and their impact on the quality of life of patients after a stroke. Material and method: Descriptive design of cross section, the sample will be composed of 600 people who attend integral rehabilitation center of regions V, VIII, IX and X in Chile, that meet the inclusion criteria and sign the informed consent. The study will include a measurement made by a trained professional from each participating center using a registration form, the FIM scale and the Barthel index, to assess quality of life. Results: It will be analyzed with the SPSS software through descriptive and inferential statistics considering the nature of the variables, all the analyzes will consider as statistically significant the results with p values less than or equal to 0.05. Depending on the interval or ordinal level of the measurements, the coefficients r of Pearson and rho of Spearman will be used to calculate the correlations. Applicability: The results will determine the prevalence in this geographical sector, disseminate this classification and promote the use of a common language among professionals to enhance their daily work. In addition, it will allow to determine how the affectation of the upper extremity through the identification of a certain pattern alters the quality of life of the patient. This new information can be a fundamental input in the generation of future studies that seek to guide in relation to the use of therapeutic strategies in these people.

The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.

This was a multicentric observational study with the aim to evaluate the effect of early treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients. All patients enrolled (86 patients) after a baseline clinical assessment (modified Ashworth scale, motricity index, Fughl Meyer assessment and modified Rankin' scale) undergoes to a BoNT-A injection following the evidence-based clinical practice. Subsequently, at 4, 12 and 24 weeks they underwent the same clinical evaluation as a follow-up. Results are under statistical evaluation.