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Spasticity, Muscle clinical trials

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NCT ID: NCT06365476 Recruiting - Stroke Clinical Trials

FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

NCT ID: NCT06214975 Recruiting - Stroke Clinical Trials

EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2)

EXOSTROKE2
Start date: October 24, 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 stroke and spasticity using Exopulse Mollii suit stimulation. The main questions it aims to answer are: to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult patients with stroke and suffering from spasticity. to assess the effects of Exopulse Mollii suit on spasticity, mobility, pain, fatigue and QoL. . 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 stroke and spasticity using Exopulse Mollii suit.

NCT ID: NCT06109129 Recruiting - Cerebral Palsy Clinical Trials

Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy

Start date: November 5, 2023
Phase: N/A
Study type: Interventional

Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. Therefore, the aim of our study is to examine the effectiveness of the Mollii Suit application on gross and fine motor function, spasticity severity, balance, walking, selective motor control, postural control, daily living activities, quality of life, pain and sleep quality in individuals with ambulatory spastic CP.

NCT ID: NCT06070233 Recruiting - Spasticity, Muscle Clinical Trials

Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy

SPASM
Start date: October 12, 2023
Phase: N/A
Study type: Interventional

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

NCT ID: NCT06051656 Recruiting - Spasticity, Muscle Clinical Trials

Effect of Cryoneurolysis on Pain in Patients With Hand Contracture.

Start date: January 9, 2023
Phase:
Study type: Observational

Contracture which is defined as a limitation of the maximum passive range of motion due to changes in periarticular soft tissue can contributes to severe pain and increased disabilities. Once contracture is present, management options are very limited and mainly includes surgery. This clinic offers cryoneurolysis routinely to spastic patients to manage their severe spasticity, contracture and associated pain. In this observational project, the outcomes after cryoneurolysis in patients with wrist and hand contracture will be studied systematically and with more details to determine any changes in pain and range of motion after this procedure.

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: 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: 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: 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.

NCT ID: NCT05518188 Recruiting - Spasticity, Muscle Clinical Trials

Melpida: Recombinant Adeno-associated Virus (Serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt)

Start date: February 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

MELPIDA is proposed for the treatment of subjects with SPG50 and targets neuronal cells to deliver a fully functional human AP4M1 cDNA copy via intrathecal injection to counter the associated neuronal loss. Outcomes will evaluate the safety and tolerability of a single dose of MELPIDA, which will be measured by the treatment-associated adverse events (AEs) and serious adverse events (SAEs). Secondarily, the trial will explore efficacy in terms of disease burden assessments.