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Muscle Spasticity clinical trials

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NCT ID: NCT04984278 Terminated - Clinical trials for Spasticity With Multiple Sclerosis

Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis

RELEASE MSS5
Start date: August 16, 2021
Phase: Phase 3
Study type: Interventional

This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 [LLMT-6]) in participants with multiple sclerosis (MS). LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS)-transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body.

NCT ID: NCT04502927 Terminated - Stroke Clinical Trials

Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients

PHYSIOHAND
Start date: March 10, 2020
Phase: N/A
Study type: Interventional

The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands. Secondary objectives: - To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers, - To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger), - To assess pain due to mobilization in stroke patients.

NCT ID: NCT04365478 Terminated - Rehabilitation Clinical Trials

Early Radial Shock Waves Treatment on Spasticity in Patients With Stroke in Sub-acute Phase

Start date: May 2, 2020
Phase: N/A
Study type: Interventional

Hands and wrist spasticity are a common post stroke complication and often lead to restrictions in daily living activities. Spasticity causes changes in muscle composition such as accumulation of collagenous connective tissue and progressive loss of skeletal muscle fibres and these changes start almost immediately after a vascular event. Radial Shock Wave Therapy (rSWT) is a valid alternative rehabilitating tool in managing chronic spasticity but no study has so far investigated the effect in a recently onset hemiparesis. The aim of this study is to evaluate the efficacy of an early radial shock wave therapy in improving spasticity of the upper limb in patients with a recent onset stroke. The secondary outcome is to investigate the improvement of upper limb motor functionality, passive range of motion and joint pain and to determine if it can lead to a better performance in daily living activities. This study is a randomized controlled trial double arm single blind. The investigators plan to enrol 40 hemiplegic patients with sub-acute stroke and randomly assign them to an experimental or control group. The experimental group (EG) will perform one radial shock wave therapy session a week for 8 weeks administered during the daily morning 40 minutes of conventional rehabilitation treatment. The control group (CG) 40-minutes of conventional rehabilitation treatment for 5 days per week in the morning for 8 weeks. All patients performed in the afternoon a second daily session of 40 minutes of conventional rehabilitation therapy 5 days per week. The Modified Ashworth Scale (MAS), Fugl-Meyer Assessment Upper Extremity (FMA-UE) (with motricity, Passive Range of Motion (PROM) and pain sub-scores of upper extremity part of the scale), Modified Barthel Index and Visual Analogue Scale (VAS) for patient's benefit perceived, will be evaluated before and a week after the last intervention. MAS will be administered once a week, before rSWT treatment. The investigators plan to have a 1 month follow up during which every outcome measure will be administered. The investigators hypothesize that radial shock waves therapy, started early and associated with traditional physiotherapy, may be more effective in promoting the reduction of spasticity and pain of the upper limb, improve its functionality and therefore a reduction in disability, compared to conventional rehabilitation treatment. A reduction in the use of analgesic and muscle relaxants drugs is also conceivable

NCT ID: NCT04203498 Terminated - Clinical trials for Multiple Sclerosis (MS)

Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis

RELEASE MSS3
Start date: October 1, 2020
Phase: Phase 3
Study type: Interventional

This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).

NCT ID: NCT04113525 Terminated - Stroke Clinical Trials

Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke

Start date: September 24, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if two courses of five consecutive sessions of noninvasive spinal stimulation paired with peripheral nerve stimulation at the forearm provided by an investigational device (Doublestimâ„¢/ MyoRegulatorâ„¢ System - PathMaker Neurosystems Inc.) are able to improve wrist stiffness and motor function, when combined with intensive robotic wrist training program in participants with chronic spastic hemiparesis after stroke.

NCT ID: NCT04054141 Terminated - ALS Clinical Trials

rTMS in Treatment of Spasticity

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

This is an open-label clinical trial to determine the safety and efficacy of rTMS in reducing spasticity and improving quality of life among patients with upper motor neuron predominant motor neuron disease (MND).

NCT ID: NCT03886753 Terminated - Cancer Clinical Trials

Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products

Ilera
Start date: May 15, 2019
Phase:
Study type: Observational

This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.

NCT ID: NCT03367429 Terminated - Stroke Clinical Trials

The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination

Start date: June 15, 2018
Phase: Phase 4
Study type: Interventional

Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is limited. The wide-spread use of BT in spasticity management, expense of these agents, and detrimental impact from movement into non-injected muscles mandates a better understanding of BT movement within muscles. A proof-of-concept paper written by investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with "voxel thresholds" that was able to detect intramuscular effects of BT at 2 and 3 months post-injection of BT. The purpose of the current set of studies is to refine this MRI technique to better visualize the movement of botulinum toxin through muscle. In addition, the investigators plan to explore, using the imaging technique, how spastic muscle and differing dilutions affect BT movement in an effort to support the development of better research techniques to study toxin movement in human muscle.

NCT ID: NCT02859428 Terminated - Clinical trials for Hereditary Spastic Paraplegia

Disease Natural History and Biomarkers of SPG3A, SPG4A, and SPG31

Start date: November 18, 2016
Phase:
Study type: Observational

Background: Hereditary spastic paraplegia (HSP) usually progresses slowly. Researchers want to learn more about how its symptoms change over time. They want to look for changes in the blood and cells of people with the most common forms of HSP that might allow them to better understand the disease. Objectives: To learn more about common forms of hereditary spastic paraplegia and find out how it progresses over time. Eligibility: People age 7 and older with SPG3A, SPG4A, or SPG31 Design: Participants will have 1 two-hour visit each year for up to 5 years. At 1 visit, adult participants may have a skin biopsy. An area of skin will be numbed then a tool will remove a small piece of skin. At all visits, all participants will have a physical exam and blood drawn. At all visits, participants will do a few tasks like walking quickly and climbing stairs. Participants can give permission for their skin cells, DNA samples, and data to be used in other studies. The samples and data will have no identifying information.

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.