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Stroke clinical trials

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NCT ID: NCT06219382 Recruiting - Stroke Clinical Trials

Neurorehabilitation Ecosystem for Sustained Therapy (NEST): A Feasibility Study

NEST
Start date: January 15, 2023
Phase:
Study type: Observational

The global burden of stroke is staggering, with over 15M new cases reported annually. Of these cases, around 40% require motor and cognitive rehabilitation, resulting in approximately 6M new patients requiring treatment each year, in addition to the more than 33M chronic patients worldwide. This massive incidence puts great pressure on healthcare systems and mounting costs. Consequently, there is an urgent need for patient-specific solutions that maximize rehabilitation efficiency and improve the patient´s performance, activities of daily living (ADLs), and quality of life. While several technological solutions have been proposed for stroke recovery during hospitalization, there is a notable lack of attention to home rehabilitation, which is crucial for long-term recovery, cost reduction and minimizing the demand for rehabilitation personnel. Investigators propose NEST, the Neurorehabilitation Ecosystem for Sustained Treatment based on the Rehabilitation Gaming System (RGS), an advanced digital rehabilitation program that uses serious gaming and Augmented Reality (AR)- and Virtual Reality VR-based training and is grounded on neuroscientific principles, that has been shown to promote motor recovery after stroke at the clinic and at home (Ballester et al., 2017; Ballester et al., 2019). NEST uses a patient's user model solution interfaced via a novel digital and portable technology to provide a home rehabilitation program accepted by the patients and clinicians. The NEST system integrates the following components: - RGS-wear advances a multimodal unobtrusive wearable interface starting from the state-of-the-art wearable technologies including off-the-shelf wearables for the detection of arm activity. This data is sent through Bluetooth to a paired smartphone, which allows for the filtering of body movements. - The RGS-Mobile App (smartphones) communicates with the RGS-wear and integrates sensor data for the delivery of patient-tailored Augmented Reality AR-based exercises for motor and cognitive training, customized feedback via the AWA coach, and activity reports through the MIMS. - The AWA Coach (Agent for Wellbeing Assistance) which provides specific feedback based on the performance and the status of well-being of the user. The user can access information through the AWA Coach dashboard (AWAtar App), which is an interface that reports their performance. and progress. It also provides the user with direct and motivational feedback and training activities in order to assist them in acting when needed. - MIMS (Medical Information Management System) is a cloud service in which relevant information on the patient's state is uploaded, allowing the monitoring of progress and the customization of the RGS-based training and evaluation protocols. Guaranteeing the correct use of this NEST ecosystem by post-stroke patients performing upper limb telerehabilitation implies conducting an usability study to measure its usability, adherence, acceptance and the user's experience. Investigators will also explore effectiveness of the NEST ecosystem in improving motor function of the paretic arm after stroke. Furthermore, uncovering end-user's experiences with NEST in an international multi-centre study should give valuable information into improving its features for a future clinical trial focusing on the effectiveness of the NEST system. This multicenter study will follow a mixed methods approach (quantitative and qualitative measurements).

NCT ID: NCT06218563 Recruiting - Healthy Clinical Trials

Study of Cerebral Activation by fNIRS During Vibration-induced Illusion of Movement in Healthy and Stroke Participants.

VIBRANIRS
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the cerebral activation of healthy and stroke participants in 4 or 2 different conditions (repeated 2 times) of vibration-induced illusion of movement respectively, resulting in 8 or 4 vibration blocks with 3 vibrations per block. The frequency of the vibration being 80 Hz. Healthy participants: - Right arm, eyes opened - Right arm, eyes closed - Left arm, eyes opened - Left arm, eyes closed Stroke participants: - Deficient side, eyes opened - Deficient side, eyes closed The aim is to compare the subjective sensation of movement score and cerebral activations of healthy/stroke participants depending on the condition.

NCT ID: NCT06215703 Recruiting - Stroke Clinical Trials

Optimizing Music-Based Interventions for Stroke

OptiMUS
Start date: February 16, 2024
Phase: N/A
Study type: Interventional

This study will enroll stroke patients and healthy participants. Participants will complete baseline measures followed by a music playing task during fMRI and simultaneous measurement of motor response using electromyography (EMG) and accelerometry and affective response using electrodermal activity (EDA) and self-reports. The music task consists of tapping an MRI-compatible MIDI drum with either: (1) improvisation or maintaining the beat and (2) live or recorded piano accompaniment. The primary objectives are to identify the motor, affective, and neural outcomes of improvisation and live accompaniment in music playing tasks.

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: 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: 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: 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.

NCT ID: NCT06210646 Recruiting - Ischemic Stroke Clinical Trials

Citicoline in Ischemic Stroke, a Randomized Trial

Start date: December 29, 2023
Phase: Phase 3
Study type: Interventional

Along with the current clinical trial, the efficacy and safety of a 1000 mg daily citicoline administered within 24 hours of the first-ever ischemic stroke and lasted 12 months compared to placebo were assessed through MoCA, NIHSS, mRS, and possible adverse effects.

NCT ID: NCT06210633 Recruiting - Stroke, Acute Clinical Trials

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

XL-STROKE
Start date: January 20, 2024
Phase:
Study type: Observational [Patient Registry]

Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT [Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core], LASTE [LArge Stroke Therapy Evaluation], RESCUE-Japan LIMIT [The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial], SELECT 2 [Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke], and TENSION [The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score [ASPECTS] ≥3 or infarct core <100ml). Patients with extra-large infarct core (volume greater than 100 mL, ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.

NCT ID: NCT06204744 Recruiting - Stroke Clinical Trials

Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial

Start date: September 8, 2023
Phase: N/A
Study type: Interventional

The goal of this multisite clinal trial is to evaluate the implementation of the home-based Graded Repetitive Arm Supplementary Program (GRASP) at rehabilitation clinics across several hospitals. The main questions it aims to answer is: • the efficacy of the home-based GRASP program relative to the conventional occupational therapy intervention on improving health outcomes, including UE motor function, daily function, quality of life, and motor control strategies. Stroke participants will be randomly assigned to either the Home-based GRASP group or the conventional occupational therapy home program group. Each group will undergo an 4 to 6-week intervention (3 sessions/week) with evaluations conducted before, immediately after, and 3 months post-trial, assessing clinical and kinematic measures. Interviews and surveys will be conducted to gain insights into the perspectives of patients regarding the implementation of the home-based GRASP program.