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Muscle Weakness clinical trials

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NCT ID: NCT06392386 Not yet recruiting - Clinical trials for Generalized Myasthenia Gravis

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis

Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study.

NCT ID: NCT06371040 Not yet recruiting - Myasthenia Gravis Clinical Trials

Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis

Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited.

NCT ID: NCT06359041 Not yet recruiting - Clinical trials for Generalized Myasthenia Gravis (gMG)

RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

Start date: August 2024
Phase: Phase 1/Phase 2
Study type: Interventional

RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis

NCT ID: NCT06353438 Not yet recruiting - Aging Clinical Trials

Hydraulic Resistance and Older Adults

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are: - Does the use of hydraulic exercise equipment decrease fall risk in older adults? - Does the use of hydraulic exercise equipment improve function in older adults? Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).

NCT ID: NCT06342544 Not yet recruiting - Clinical trials for Ocular Myasthenia Gravis

Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial.

IMCOMG
Start date: June 2024
Phase: Phase 3
Study type: Interventional

Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness. In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease. Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants. There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens. On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile. We propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis. Patients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant. The aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off.

NCT ID: NCT06331039 Not yet recruiting - Clinical trials for Urinary Incontinence

The Effects of Pelvic Floor Muscle Training and Balance Exercises in Elderly People With Incontinence

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems. The aim of this study is to examine the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence.

NCT ID: NCT06319937 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Muscle Architecture in Knee Osteoarthritis

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women. Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy).

NCT ID: NCT06306703 Not yet recruiting - Clinical trials for Pelvic Floor Muscle Weakness

Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women

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

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.

NCT ID: NCT06221501 Not yet recruiting - Myasthenia Gravis Clinical Trials

Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

Start date: February 1, 2024
Phase: Phase 2
Study type: Interventional

It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.

NCT ID: NCT06205147 Not yet recruiting - Muscle Weakness Clinical Trials

Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly.

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

With improved a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals. This study is a random control trial. Data collection includes elderly patient's total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized. The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.