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Muscle Spasticity clinical trials

View clinical trials related to Muscle Spasticity.

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NCT ID: NCT02604186 Completed - Clinical trials for Hereditary Spastic Paraplegia

Effects of Botulinum Toxin Injections in Patients With Hereditary Spastic Paraplegia

SPASTOX
Start date: March 9, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common predominant feature of spasticity of the lower limbs. The clinical picture is composed of difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski sign, sphincter disturbances and various degrees of weakness as well as sensory disturbances. Spasticity is the symptom that provoques greater incapacity. Although there have been recent advances in the genetic and pathogenic characterization of SPG there is scarcity of therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke. Therefore, the investigators propose the execution of a randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter walking test 8 weeks after injection. Each participant will be submitted to one injection session of Btx and one of placebo (consisting of sterile sodium chloride), each one separated by a period of 6 months. The primary and secondary outcomes will be evaluated by a blind investigator 8 weeks after each injection session.

NCT ID: NCT02557737 Recruiting - Clinical trials for Cerebrovascular Accident

Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities

Start date: September 2012
Phase: Phase 3
Study type: Interventional

The aims of this study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness.

NCT ID: NCT02550509 Terminated - Stroke Clinical Trials

Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle

Start date: November 2013
Phase: N/A
Study type: Interventional

Muscle alterations and modifications passive biomechanical properties that occur on a spastic muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is the reference treatment of the focused spasticity, and muscle source structural and biomechanical changes, very little studied in humans, especially since it is not one possibility of easily and reliably paraclinical assessment injections consequences.

NCT ID: NCT02546999 Completed - Cerebral Palsy Clinical Trials

Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?

WE
Start date: September 2015
Phase: Phase 4
Study type: Interventional

In Norway, about 60% of all children with cerebral palsy (CP) are being treated with botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread use of the drug, the evidence for a positive effect on walking is insufficient. Moreover, large variation in effect is seen by clinicians. The main objective of the present study is to investigate whether injections with BoNT-A in the calf muscles make walking easier in children with spastic CP within 6 months, reflected by reduced energy cost during walking.

NCT ID: NCT02542787 Completed - Clinical trials for Spasticity in People With Multiple Sclerosis

Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Start date: August 2015
Phase: Phase 2
Study type: Interventional

Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

NCT ID: NCT02535936 Recruiting - Spastic Diplegia Clinical Trials

Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

Start date: August 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

NCT ID: NCT02505802 Recruiting - Stroke Clinical Trials

The Effectiveness of Early Botulinum Toxin A Injection for Lower Limbs Spasticity in Subacute Stroke Adults

Start date: January 2014
Phase: Phase 4
Study type: Interventional

Botulinum toxin A (BoNT-A) injections are widely used to treat spasticity after stroke. Although this treatment is effective on muscle tone improvement, its effect on gait and ability of daily living on early stage of stroke adults remains uncertain.The purpose of this study is to determine whether an early calf muscle injection of low dose BoNT-A in severely affected patients within 6 weeks after stroke could help to hold back disabling muscle spasticity and improve walking dysfunction.

NCT ID: NCT02470325 Recruiting - Dystonia Clinical Trials

The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients

Start date: July 2015
Phase: Phase 2
Study type: Interventional

A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in children with neurological diseases. The clinical trial will include 40 children divided into two groups: children with spasticity and dystonia due to cerebral palsy, and children with spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various variables will be collected including: medication intake, spasticity, dystonia score, pain scale, restlessness scale, quality of life measures, safety tests, side effects, and an addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improve motor function, non-motor functions and quality of life.

NCT ID: NCT02469948 Not yet recruiting - Clinical trials for Cerebrovascular Accident

Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities

Start date: October 2015
Phase: Phase 3
Study type: Interventional

Stroke may result in lower extremity spasticity, which interfere with motor voluntary function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to improve lower extremity spasticity of stroke patients. There are no researches to compare the efficiency of BTX-A injection by different guidance methods in the deep muscles of lower extremity for stroke patients. The aims of investigator's study were to compare the effectiveness of BTX-A injection by different guidance methods (palpation of anatomical landmarks, ultrasonography direct) in deep spastic muscles of lower extremity for stroke patients with varus spasticity and spastic claw toes , and to study the correlation between muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw toes and duration more than 6 months. Under different guidance methods (palpation of anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods), BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected. The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth Scale, Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain, Stroke Impact Scale, Barthel index and lower extremity function tests, balance test, Goal Attainment Scale, sonoelastography and acoustic radiation force impulse imaging. All the assessments will be performed before BTX-A injection and followed up at 1 months, 2 months, 3 months and 6 months after injection. After performing all the assessments, investigator will investigate the efficiency of BTX-A by different guidance methods.

NCT ID: NCT02462317 Completed - Muscle Spasticity Clinical Trials

Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment

BacloTox
Start date: April 2015
Phase: Phase 4
Study type: Interventional

Stroke is the first cause of motor impairment and disability in adults. Then the main objective of rehabilitation during the first six months following stroke is to facilitate motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an increase of disability. Then antispastic drugs are frequently prescribed to the patients even during the post-stroke recovery phase. Until recently most of french patients were treated by oral tablets of baclofen. Now the number of patients receiving intramuscular injections of botulinum A toxin is increasing. However in the literature, these drugs have been tested in post-stroke spasticity during the chronicle phase, after the sixth month and their action on motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the effects of its drugs on motor recovery. The main criterion of its study is the time course of Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two months, will be included in the try. They receive at the same time oral tablets for five months and intramuscular injections. Patients are randomized in three arms planned with a distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients), placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed before treatment start, one month and three months later. Spasticity, functional abilities, capacity in the activities of daily life, pain and quality of life will be also assessed during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive difference of 12 points in the time course of FMA in the botulinum toxin group in comparison with the baclofen group will be considered as the minimum relevant effect. 300 patients have been planned to be included in 20 centers during the 2 years of trial.