Research on the Effectiveness of Neurorehabilitation After Stroke
NCT ID: NCT06753006
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2024-08-27
2025-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
The Control group receives a standard course of intervention (14-21 days) as prescribed by the attending physician, in accordance with the standards of the Ministry of Health of the Russian Federation for the provision of medical care to people who have suffered a stroke.
Standard course
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
MI+VR
In addition to the standard course of intervention, the MI+VR group undergoes 10-12 sessions using a novel simulator involving the paretic arm with immersion in virtual reality.
Standard course
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
Neurorehabilitation simulator
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
MI2+VR
In addition to the standard course of intervention, the MI2+VR group undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) with immersion in virtual reality.
Standard course
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
Neurorehabilitation simulator
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
MI2
In addition to the standard course of intervention, the group MI2 undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) without immersion in virtual reality, using a computer display instead.
Standard course
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
Neurorehabilitation simulator
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
Interventions
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Standard course
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
Neurorehabilitation simulator
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Samara State Medical University
OTHER
Samara Regional Clinical Hospital V.D. Seredavin
OTHER
Neurotechnika
INDUSTRY
Responsible Party
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Principal Investigators
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Alexander Zakharov, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samara State Medical University
Locations
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Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, Samara Oblast, Russia
Countries
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Central Contacts
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Alexander Zakharov, Ph.D.
Role: CONTACT
Facility Contacts
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Alexander Zakharov, Ph.D.
Role: backup
Other Identifiers
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NT-STROKE-2024-09
Identifier Type: -
Identifier Source: org_study_id
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