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Muscle Weakness clinical trials

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NCT ID: NCT06463587 Not yet recruiting - Clinical trials for Generalized Myasthenia Gravis

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

Start date: June 17, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period.

NCT ID: NCT06458530 Not yet recruiting - PreDiabetes Clinical Trials

Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

NCT ID: NCT06456580 Not yet recruiting - Clinical trials for Generalized Myasthenia Gravis

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG)

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

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of generalized myasthenia gravis.

NCT ID: NCT06445491 Not yet recruiting - Muscle Weakness Clinical Trials

Effect of Sequencing on Outcome Measures

Start date: June 2024
Phase: N/A
Study type: Interventional

This pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence.

NCT ID: NCT06441422 Not yet recruiting - Weakness, Muscle Clinical Trials

Blood Flow Restriction Training for People With Disabilities

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

A large portion of the American population live with disabilities. People with disabilities can find it difficult to perform standard exercise routines. Regular exercise is necessary to be healthy, especially as people age. Lack of exercise can lead to secondary health concerns, like loss of muscle mass, diabetes, heart attack or stroke, to name a few. For exercise to be most beneficial, a certain degree of intensity must be achieved. Low load blood flow restriction training may be able to mimic the intensity of beneficial exercise without actually exercising hard. It may be a good option for people with disabilities who find it difficult to exercise.

NCT ID: NCT06435312 Not yet recruiting - Clinical trials for Generalized Myasthenia Gravis

An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

ziMyG+
Start date: August 13, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants

NCT ID: NCT06430879 Not yet recruiting - Muscle Weakness Clinical Trials

Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential

POWER-UP
Start date: July 10, 2024
Phase: N/A
Study type: Interventional

This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved observational study with functional measurements, will evaluate athletic performance after use of a drug- free, non-invasive patch (VICTORY Patch; The Super Patch Company Inc.); using KangaTech, Catapult and Force Plates along with crossover control of trials within the same subject group not receiving an 'active' patch.

NCT ID: NCT06419699 Not yet recruiting - Muscle Weakness Clinical Trials

CPAx: Responsiveness and Minimal Clinically Important Difference

Start date: May 2024
Phase:
Study type: Observational

Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.

NCT ID: NCT06414954 Not yet recruiting - Myasthenia Gravis Clinical Trials

Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

SYNAPSE-MG
Start date: May 2024
Phase: Phase 2
Study type: Interventional

This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.

NCT ID: NCT06409754 Not yet recruiting - Stroke Clinical Trials

BCI-FES for Upper Limb Rehabilitation in Chronic Stroke

BCI-FES
Start date: June 2024
Phase: N/A
Study type: Interventional

The objective of this research is to evaluate the benefits of an experimental therapy for motor recovery of the arm after a stroke, which includes the application of a functional electrical stimulation therapy coupled to P-300 based Brain-Computer Interface system (BCI-FES). For this purpose, the investigators will compare two groups, the first one will receive only conventional physical and occupational therapy, while the second one will receive conventional therapy together with BCI-FES therapy. The control and experimental group will receive 20 sessions of conventional physical and occupational therapy at a rate of five sessions per week for 4 weeks (control group double dose of conventional therapy), and the experimental group will receive 20 sessions of rehabilitation with the BCI-FES system at a rate of five sessions per week for 4 weeks. Broadly speaking, the BCI is in charge of determining the movement selected by the individual and assist the hand movement while performing functional tasks. The movements included in the sessions will be hand opening, grasping, pinching, pronation and supination, which are combined to facilitate the execution of functional movements that are performed together with the manipulation of daily used utensils. The visual, sensory and motor feedback provided by the BCI-FES system that enables the individual to replicate the afferent-efferent motor circuit, contributes to the activation and recruitment of neural pathways, which is associated with motor recovery. It should be noted that this BCI-FES system has already been tested previously in a study with healthy individuals, and in a non-randomized pilot study that used this therapy for upper limb motor function recovery in chronic post-stroke patients. To evaluate the results, a series of tests will be applied to assess the motor recovery, including the FMA-UE: Fugl-Meyer Assessment Scale of Upper Extremity, ARAT: Action Research Arm Test, MAS: Modified Ashworth Scale, FIM: Functional Independence Measure and MAL: Motor Activity Log. Likewise, resting state functional magnetic resonance imaging studies will be performed to evaluate the degree of functional connectivity between various brain regions of interest related to the planning and execution of movements. This will determine whether the experimental therapy with BCI-FES favors arm and hand recovery in surviving stroke individuals.