Research on the Effectiveness of Neurorehabilitation After Stroke

Launched by NEUROTECHNIKA · Dec 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help adults recover from strokes using advanced technology. The study focuses on a simulator that combines robotic assistance, a brain-computer interface (which helps move the arm by detecting brain signals), and virtual reality to make rehabilitation more engaging. Researchers want to see if this innovative approach improves arm function better than traditional rehabilitation methods and to determine how safe and effective it is.

To participate in this trial, individuals must be between 18 and 80 years old and within six months of their stroke. They should have some weakness in their arm but still be motivated to engage in rehabilitation. Participants will take part in 10-12 sessions where they will use the simulator to perform tasks that mimic real-life activities while receiving support from the robotic device and virtual reality. It's a promising opportunity for those looking for new ways to regain arm movement after a stroke!

Gender

ALL

Eligibility criteria

• 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.