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RECRUITING

NCT06753006

Research on the Effectiveness of Neurorehabilitation After Stroke

Sponsor: Neurotechnika

View on ClinicalTrials.gov

Summary

This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies. Key Research Questions: Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques? BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements? VR Contribution: How does the integration of VR enhance rehabilitation outcomes? Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator? Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display. Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.

Official title: A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-27

Completion Date

2025-07

Last Updated

2025-01-01

Healthy Volunteers

Conditions

Stroke Stroke Acute Stroke with Hemiparesis Stroke, Acute Stroke, Acute, Ischemic Stroke, Ischemic

Interventions

DEVICE

Neurorehabilitation simulator

The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.

PROCEDURE

Standard course

The participant receives a standard course of intervention as prescribed by the attending physician in accordance

Inclusion Criteria: * Signed written informed consent. * Age 18 to 80 years at the time of stroke onset. * Early rehabilitation period (up to 6 months post-stroke). * Diagnosis of acute cerebrovascular accident confirmed by MRI or CT. * Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale. * Ability and willingness to comply with the study protocol. * Demonstrated motivation for rehabilitation. Exclusion Criteria: * Montreal Cognitive Assessment scale (MoCA) score less than 10 points. * Hamilton Depression Rating Scale (Ham-D) score greater than 18 points. * Modified Rankin Scale (mRS) score greater than 4 points. * Pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures). * Advanced arthritis or significant limitation of upper limb range of motion. * Absence of part of the upper limb due to amputation for any reason. * Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness). * Alcohol abuse or recreational drug use within the 12 months preceding the study. * Use of experimental medications or medical devices within the 30 days preceding the study. * Inability to comply with research procedures, as determined by the researcher. * The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation. * Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart. * Unstable angina and/or heart attack within the 30 days preceding the study. * Recurrent stroke. * Uncontrolled arterial hypertension. * Ataxia. * Presence of a pacemaker and/or other implanted electronic devices. * Use of muscle relaxants. * Peripheral neuropathy. * Coexisting diseases in an exacerbation or decompensated stage requiring active treatment. * Allergic reactions or other skin lesions at the EEG electrode application sites at the time of the study. * Acute urinary tract infections. * Acute thrombophlebitis. * Any form of epilepsy. * Benign and malignant neoplasms.

Locations (1)

Samara Regional Clinical Hospital named after V.D. Seredavin

Samara, Samara Oblast, Russia