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Stroke clinical trials

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NCT ID: NCT06215625 Recruiting - Stroke Clinical Trials

A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries

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

The goal of this clinical trial is to investigate the effectiveness of the developed application and exoskeleton robot devices for home-based training in stroke patients and patients with spinal cord injuries. The application that uses an Internet of Things (IoT) platform to enable remote monitoring of rehabilitation progress by clinical practitioners. Simultaneously, it seeks to assist the execution of patient movements through devices. In patients with stroke, half of the participants will be assigned to experimental group, receiving a smart upper limb motor rehabilitation system for home program. The other half will be assigned to control group, receiving a traditional home program. In patients with spinal cord injuries. Participants will follow the same allocation method for home-based intervention. Researchers will conduct an analysis before and after intervention, examining progress in motor function, activities of daily living, and quality of life.

NCT ID: NCT06215157 Not yet recruiting - Clinical trials for Fluid Responsiveness

A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness

Start date: January 30, 2024
Phase: N/A
Study type: Interventional

Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.

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: NCT06214494 Enrolling by invitation - Stroke, Ischemic Clinical Trials

Blood Flow Restricted High-Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors

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

Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. The main question we aim to answer is: How does blood flow restricted high-intensity treadmill training impact walking function? Participants will be randomly separated into two groups. One group will perform the high intensity treadmill training with blood flow restriction on their Stroke affected leg, while the second group performs high intensity treadmill training only. Every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. On visit 1, participants will undergo strength, balance, and walking testing. They will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. Participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. Researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.

NCT ID: NCT06214091 Not yet recruiting - Stroke Clinical Trials

Gastrointestinal Decompression in Stroke

EAGER-ASSIST
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Acute severe ischemic stroke is a life-threatening subtype of stroke. Due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. Reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. Gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. Early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. Therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.

NCT ID: NCT06213597 Completed - Stroke Clinical Trials

Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic

Start date: May 28, 2023
Phase: N/A
Study type: Interventional

This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).

NCT ID: NCT06213376 Enrolling by invitation - Stroke Clinical Trials

MIT Intensive Treatment Study

MITTXS
Start date: December 28, 2023
Phase: N/A
Study type: Interventional

This study is examining the use of intensive melodic intonation therapy and video feedback as a means of aiding individuals with nonfluent aphasia and co-occurring motor speech impairments. Individuals with nonfluent aphasia have difficulty with language, particularly with word retrieval.

NCT ID: NCT06213272 Recruiting - Stroke Clinical Trials

Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.

NCT ID: NCT06212674 Not yet recruiting - Atrial Fibrillation Clinical Trials

Complex Percutaneous Pulmonary Vein Isolation Combined With Left Atrial Appendage Occluder Implantation for Patients With Cardiogenic Ischemic Stroke in the Course of Atrial Fibrillation

PILOS-AF
Start date: January 31, 2024
Phase: N/A
Study type: Interventional

The project is a multicenter, open-label, randomized medical experiment, which was designed to evaluate the efficacy and safety of single-stage pulmonary vein isolation (PVI) and implantation of left atrial appendage occluder (LAAO) in comparison with either isolated LAAO implantation or chronic therapy with non-vitamin K antagonists anticoagulants (NOAC) in patients with recent-onset ischemic stroke and atrial fibrillation (AF). Based on former randomized controlled trials, percutaneous implantation of LAAO was shown to be non-inferior to vitamin K antagonists (VKA), but according to guidelines the use of LAAO is recommended only in patients with absolute contraindication to chronic anticoagulation therapy. PVI constitutes an acknowledged rhythm control management strategy in patients with paroxysmal and persistent AF, which leads to symptomatic relief in about 60% of treated patients, however, its beneficial effect on long-term outcome was demonstrated only in patients with heart failure with reduced ejection fraction. The feasibility and compatibility of both interventions performed as a combined single-stage procedure are warranted by common vascular access via transseptal puncture, which may lead to reduction of procedural cost and shortened overall duration of both interventions. Taking into consideration the preliminary registry data, the combined single-stage PVI and LAAO implantation are thought to be a safe procedure in patients with a high risk of recurrent ischemic stroke and cardiovascular death. The study will comprise 240 patients who were diagnosed with ischemic stroke within preceding 6-12 weeks, with confirmed paroxysmal or persistent AF and low-to-moderate psychomotor dysfunction in the course of cerebral incident, who completed early neurological rehabilitation and are characterized by high risk of ischemic stroke recurrence (CHA2DS2-VASc score ≥2 pts in men; ≥3 pts in women) and who received adequate oral anticoagulation therapy (NOAC/VKA) for ≥4 weeks. After exclusion of thrombus and potential anatomical contraindications to the procedure on transesophageal echocardiography, patients will be randomized in 1:1:1 ratio to study group treated with combined single-stage PVI + LAAO implantation during 3-day hospitalization and to control group subject to LAAO implantation or control group subject to chronic therapy with NOAC. The duration of active enrollment phase will be 18 months. Subsequent follow-up phase will include scheduled outpatient visits (at 3, 12, 48 months) and phone call interview (at 6, 18, 24, 36 months) in order to evaluate the occurrence of clinical and safety endpoints, medical symptoms and signs, quality of life reflected by structured questionnaire, the presence of AF on 7-day Holter electrocardiography. Follow-up visits will also include blood laboratory tests analysis, including biomarkers of heart failure and left atrial wall stress, as well as transthoracic echocardiography with tissue Doppler imaging and strain imaging. In addition, patients in study group and control group treated with LAAO will attend additional outpatient visit at 6 weeks in order to perform transesophageal echocardiography so as to confirm procedural success and allow for termination of chronic anticoagulation therapy. Co-primary composite endpoint will comprise cardiovascular death, ischemic stroke, transient ischemic attack, systemic arterial embolism and major non-procedural bleeding, including intracranial bleeding (non-inferiority). The current project was based on the preliminary results of nonrandomized studies, which delivered evidence for feasibility of combined single-stage PVI and percutaneous left atrial appendage closure and laid ground for future randomized controlled trials. It is expected that the proposed intervention will be non-inferior in terms of composite cerebrovascular events and superior in terms of major nonprocedural bleeding in comparison to chronic NOAC therapy.

NCT ID: NCT06212219 Recruiting - Clinical trials for Cerebrovascular Accident

Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Neurofeedback (NF) is a procedure for providing direct sensory feedback (in the form of visual, auditory or tactile stimulation) to a patient about their brain activity when performing a cognitive or motor task. This NF aims to allow the patient to become aware of this brain activity and thus learn to modulate it voluntarily in order to improve the performance obtained on the task. The aim of the study is to compare a "standard NF" procedure to a "personalized NF" procedure designed to optimize the level of patient acceptability based on the results obtained through these questionnaires.