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Spasticity, Muscle clinical trials

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NCT ID: NCT04714385 Completed - Chronic Pain Clinical Trials

Medtronic PSR TDD PMCF

Start date: February 9, 2017
Phase:
Study type: Observational

The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

NCT ID: NCT04574622 Completed - Cerebral Palsy Clinical Trials

Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy

Start date: January 17, 2020
Phase: N/A
Study type: Interventional

Spasticity, defined as a velocity dependent increase in tonic stretch reflexes, is one of the most prominent motor problems that occur in patients with cerebral palsy (CP). This causes difficulty in achieving balance, mobility, and an upright stance. CP is a group of permanent disorders that affect the development of movement and posture caused by a non-progressive damage to the brain. Because CP occurs in 2-3 of 1000 individuals, it is one of the most common causes of severe physical disability in children. Mismanagement of spasticity can lead to contracture which is extremely difficult to treat and may result in severe functional disabilities. The current management of spasticity in CP includes physical therapy (i.e. passive stretching), oral medication, botulinum toxin injection, and surgery. Botulinum toxin injection has been proven to effectively reduce spasticity yet many patients are unable to get access to this treatment due to its high cost. Moreover, Botulinum toxin injection is currently not covered by the public health insurance of Indonesia. Therefore, other modalities which are more affordable and are non-invasive therapies should be considered as a treatment option for spasticity. Radial Extracorporeal Shockwave Therapy (rESWT) has been utilized in the medical practice for the treatment of several musculoskeletal disorders such as chronic tendinopathies and spasticity. It is hypothesized that ESWT has two main effects which include a direct effect from mechanical forces at the treatment point and an indirect effect from cavitation. Even though rESWT has less penetration capacity over the focused Extracorporeal Shockwave Therapy (fESWT), rESWT is still believed to be more superior to fESWT because it requires less precise focusing, is less painful, and costs less. These also make rESWT the more appropriate choice for children with CP. Many studies have proven the efficacy of ESWT in reducing spasticity in spastic CP patients with significantly long lasting effects. Despite promising results, there still has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One of the critical parameters needed to be determined is the frequency of treatment. Therefore, the objective of this study is to understand whether the reduction in gastrocnemius stiffness in children with spastic CP is influenced by the frequency of ESWT sessions.

NCT ID: NCT04546035 Completed - Cerebral Palsy Clinical Trials

Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy

Start date: January 17, 2020
Phase: N/A
Study type: Interventional

Cerebral palsy (CP) is a group of permanent disorders affecting movement and postural development that are caused by non-progressive disruptions of the brain, usually occurring during fetal period or infancy. It is commonly accompanied with sensory disorders and learning disability. In 2016, more than 17 million people are affected by CP with a prevalence of 1.5 to 2.5 per 1,000 live births. CP remains to be the most common cause of severe physical disability in children. The Centres for Disease Control and Prevention (CDC) estimated an economic cost of US$4.1 million per CP patient that comprises of medical services, special education and productivity loss. Current management of spasticity involves physical manipulation such as passive stretching and splinting, sometimes combined with oral pharmacologic treatment, intrathecal baclofen therapy and botulinum toxin injection. At times, surgical procedures such as Surgical Dorsal Rhizotomy (SDR) can also be considered. Botulinum toxin injection has been shown to reduce spasticity for up to 6 months, however, the cost of the procedure remains to be an issue in developing countries like Indonesia. Therefore, other modality such as a non-invasive therapy should be considered as an alternative treatment for spasticity. Radial Extracorporeal Shockwave Therapy (rESWT) is a non-invasive treatment that has been shown to effectively improve spasticity in patients with spastic motor type CP, despite unclear underlying mechanism. According to International Society for Medical Shockwave Treatment (ISMST), there has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One crucial physical parameter needed to be determined is the number of pulse required to efficiently reduce spasticity. The number of pulse directly affects the duration of ESWT per session (the higher the number of pulse given, the longer the therapy session). This may be a concern for spastic motor type CP due to accompanying sensory and learning disability. Therefore, the objective of this study was to understand whether the reduction in hamstring stiffness in children with spastic CP could be influenced by the number of pulse in a single ESWT session.

NCT ID: NCT04266964 Completed - Clinical trials for Spinal Cord Injuries

Validity and Reliability Study of the Muscle Excitability Scale in Spinal Cord Injury Patients

Start date: January 2, 2020
Phase:
Study type: Observational

The aim of the study is to verify validity and reliability of the Muscle excitability scale (MES), which has been developed to access muscle susceptibility to spasms and/or clones as part of spastic motor behavior in spinal cord injured patients.

NCT ID: NCT04130295 Completed - Clinical trials for Spinal Cord Injuries

Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the quality of life of people with spinal cord injury (SCI). In people with spinal cord injury, spasticity can limit muscle control of the arms and hands and cause pain, discomfort, and frustration. Transcutaneous electrical stimulation has been shown to reduce spasticity after SCI. However, this type of stimulation's effects during prolonged, at-home use has not been well studied. Additionally, traditional stimulation techniques are often only available in the clinic. Therefore, this study aims to identify if wearable intensive nerve stimulation decreases spasticity in the legs of people with SCI, and if this intervention is usable and desirable to individuals with SCI.

NCT ID: NCT04076878 Completed - Stroke Clinical Trials

Effects of Using the Electrodress Mollii on Spasticity

Start date: August 15, 2017
Phase: N/A
Study type: Interventional

Spasticity is a common manifestation of lesions of central motor pathways, such as after stroke, traumatic brain or spinal cord injury and in cerebral palsy and is associated with increased impairments and disabilities. Spasticity may be associated with pain and contractures, caused by muscle weakness, reduced muscle length and volume that add to the disability.Treatments of spasticity comprise physical therapy, pharmacological agents and surgical treatment. Recently, a systematic review concluded that transcutaneous, electric nerve stimulation may have beneficial effects on spasticity and activity performance after stroke, which lends support to the new treatment method Mollii, which will be evaluated in this study.The Mollii suit provides electric stimulation through multiple electrodes places in a tight fitting suit. This study relates to the clinical trials performed at the University department of rehabilitation medicine at Danderyd Hospital in Stockholm and comprises an initial study of effects on spasticity ("Mechanical substudy") and a following, exploratory treatment trial ("Clinical substudy") in patients with spasticity after stroke.

NCT ID: NCT04022187 Completed - Spasticity, Muscle Clinical Trials

Assessment of the Excitability of Spinal Motoneurons Using Stimulus-response Curves of the Bulbocavernosus Reflex

Start date: July 11, 2019
Phase:
Study type: Observational

Spasticity is commonly observed in neurological conditions such as Multiple Sclerosis and spinal cord injury. "Peripheral" spasticity, concerning in particular the striated muscles of the limbs is nowadays well known and studied with clinical scales (Ashworth, Taridieu...) or even electrophysiological methods (H-reflex, T-reflex...). However, this spasticity can also affect the perineal muscles and more generally the pelvic muscles. However, there is to date no validated and standardized method for evaluating this pelvi-perineal spasticity. The aim of the study will be to assess the spinal motoneurons excitability by using the stimulus-response curves of the bulbocavernosus reflex.

NCT ID: NCT03931824 Completed - Shoulder Pain Clinical Trials

Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain

Start date: January 7, 2015
Phase: N/A
Study type: Interventional

In this study assessing whether platelet rich plasma injections(PRP) are effective in the management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited to this randomized controlled study. Patients were randomized into two groups, first getting PRP injections, and other group taking sham injections.

NCT ID: NCT03908580 Completed - Spasticity, Muscle Clinical Trials

MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity

Start date: September 6, 2013
Phase: Phase 4
Study type: Interventional

This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".

NCT ID: NCT03797573 Completed - Spasticity, Muscle Clinical Trials

Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

Start date: January 20, 2014
Phase: Phase 1
Study type: Interventional

Previous studies showed that transcranial direct current stimulation (tDCS) transiently improves performance of motor function in stroke patients, as well as decrease muscle hypertonia. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other brain areas could be stimulated in order to manage other symptoms occurring in this population of patients, such as muscle hypertonia. In this study, investigators will assess the effects of bilateral fronto-central tDCS on spasticity as measured with the Modified Ashworth Scale (MAS) and on the Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.