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Spasticity, Muscle clinical trials

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NCT ID: NCT05912595 Recruiting - Spasticity, Muscle Clinical Trials

EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)

Start date: May 18, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate the improvement of muscular oxygenation in patients with Multiple Sclerosis and spasticity using Exopulse Molli suit stimulation. The main questions it aims to answer are: - to evaluate the short-term impact of EXOPULSE Molli suit on muscular oxygenation in adult MS patients suffering from spasticity. - to assess the effects of Exopulse Mollii suit on spasticity, pain, fatigue, quality of life (QoL), walking and risk of fall. Study subjects will participate in: - One baseline visit for inclusion in the study during which the patient will undergo the first session (active or sham) along with an evaluation before and after the session - One visit after two weeks during which the patient will undergo the second session (active or sham) along with an evaluation before and after the session - One visit two weeks after the second stimulation; where the patients will undergo a fifth evaluation and receive the EXOPULSE Molli Suit for the four-week open label phase to use the suit at home for an active stimulation session every other day for four weeks. - One visit at the end of the open label phase to perform the sixth and last evaluation and return the EXOPULSE Molli suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of muscular oxygenation in patients with MS and spasticity using Exopulse Molli.

NCT ID: NCT05887479 Withdrawn - Clinical trials for Cerebrovascular Disorders

The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity

Start date: May 25, 2023
Phase: Phase 4
Study type: Interventional

The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).

NCT ID: NCT05857280 Recruiting - Spasticity, Muscle Clinical Trials

EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. The main questions it aims to answer are: - to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult MS patients suffering from spasticity. - to assess the effects of EXOPULSE Mollii suit on mobility, upper and lower limbs muscle tone, pain, fatigue and quality of life. Participants will participate in: - One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session) - One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session) - One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will use the suit at home for an active stimulation session every other day for four weeks. - One visit at the end of the open label phase to perform the fourth and last evaluation and return the EXOPULSE Mollii suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit.

NCT ID: NCT05702606 Completed - Cerebral Palsy Clinical Trials

Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.

NCT ID: NCT05687097 Recruiting - Clinical trials for Spinal Cord Injuries

Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury

Start date: September 1, 2020
Phase:
Study type: Observational

This cross-sectional prospective study will assess the potential association of more severe sleep apnea after spinal cord injury with more intense neuropathic pain, more severe spasticity, and more significant cardiovascular abnormalities including cardiac arrhythmias and blood pressure fluctuations. In addition, the participants' experience when undergoing home-based sleep screening test or hospital-unattended sleep screening test will be assessed in a semi-structured interview.

NCT ID: NCT05626790 Active, not recruiting - Stroke Clinical Trials

Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

The patients who were diagnosed with stroke in governmental/university/private hospitals, and who needed rehabilitation because of the increased flexor tone in the elbow joint, decreased range of motion and/or decreased function of the upper extremity will be invited to the study in accordance with the criteria that are given in inclusion and exclusion part. Participants will be randomly assigned to one of two parallel groups, either the PNF Stretching Group (n=17) or the Prolonged Stretching Group (n=17), according to the order of participation in the study by simple randomization. An online computer program will be used to assign participants (https://www.randomizer.org/). Exercises that will increase proximal stabilization and control will be applied to both groups for 4 weeks, 5 days a week. In addition to the exercises, prolonged stretches for 10 minutes will be applied to the Prolonged Stretching Group, and PNF stretching will be applied to the PNF Stretching Group. At the beginning and the end of the study, muscle architecture, muscular viscoelastic properties, range of motion, proprioception, upper extremity motor performance and function and posture will be evaluated.

NCT ID: NCT05598736 Enrolling by invitation - Pain Clinical Trials

Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain

Start date: November 4, 2022
Phase: N/A
Study type: Interventional

This study is based on a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS) (NCT05562453). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period (NCT05562453), all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part. The participants who volunteer to continue in the 6-months optional extension part will be included in this study.

NCT ID: NCT05562453 Active, not recruiting - Multiple Sclerosis Clinical Trials

Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain

FO-NP002
Start date: October 4, 2022
Phase: N/A
Study type: Interventional

The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.

NCT ID: NCT05559255 Active, not recruiting - Pain Clinical Trials

Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI

Start date: September 9, 2022
Phase: N/A
Study type: Interventional

Individuals with spinal cord injury (SCI) often suffer from pain and spasticity. Traditional treatments for both of these conditions have been medications. However, it has been suggested that the counterstrain osteopathic manual manipulation treatment can decrease pain and possibly spasticity. The aim of this study is to investigate the effects of counterstrain osteopathic manual manipulation treatment on pain and spasticity in individuals with SCI.

NCT ID: NCT05518565 Recruiting - Cerebral Palsy Clinical Trials

The Muscle in Cerebral Palsy; Sarcomere Length in Vivo and Microscopic Characterization of Biopsies.

CPMuscleSL
Start date: January 15, 2002
Phase:
Study type: Observational

Cerebral palsy (CP) is a motor impairment due to a brain malformation or a brain lesion before the age of two. Spasticity, hypertonus in flexor muscles, dyscoordination and an impaired sensorimotor control are cardinal symptoms. The brain lesion is non-progressive, but the flexor muscles of the limbs will during adolescence become relatively shorter and shorter (contracted), forcing the joints into a progressively flexed position. This will worsen the positions of already paretic and malfunctioning arms and legs. Due to bending forces across the joints, bony malformations will occur, worsening the function even further. Currently, the initial treatment of choice is the use of braces, which diminishes the shortening somewhat, but eventually lengthenings of tendons and release of aponeuroses around the muscles often is needed, and transfers of wrist flexors to wrist extensors may improve wrist position. But the long-term results are unpredictable- how much does the muscle need to be lengthened? What muscles should be transferred for a better position of the wrist, and at what tension? A method to measure sarcomere length in vivo has been developed. The sarcomere, the distance between two striations, is the smallest contractile unit in the striated muscle. When, during surgery, a muscle fiber bundle is transilluminated with a low energy laser light, a diffraction pattern is formed. This diffraction pattern reflects the sarcomere length, and thereby an instant measure of how the stretch of the muscle is obtained. When performing tendon transfers of e.g. wrist flexors to wrist extensors, the setting of the tension of the transfer is arbitrary, and the long-term result is unpredictable. Laser diffraction measurements will give a guide to a precise setting of tension. It is known that there may be pathological changes in muscle in cerebral palsy that also will affect the long-term results of tendon lengthenings and transfers. In order to also take these changes into account, small muscle biopsies will be taken during the same surgeries. These will be examined with immuno-histochemical and biochemical techniques, gel-electrophoresis as well as electron microscopy.