Research on the Effectiveness of Neurorehabilitation After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neurorehabilitation simulator, Standard course.
- Who it may be relevant to
- Registry conditions: Stroke, Stroke Acute, Stroke with Hemiparesis, Stroke, Acute. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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
Primary outcome measures
- FMA-UE A-D [Time frame: From enrollment to the end of treatment at 2-3 weeks]
- ARAT [Time frame: From enrollment to the end of treatment at 2-3 weeks]
Secondary outcome measures (5)
- NIHSS [Time frame: From enrollment to the end of treatment at 2-3 weeks]
- Ashworth [Time frame: From enrollment to the end of treatment at 2-3 weeks]
- RMI [Time frame: From enrollment to the end of treatment at 2-3 weeks]
- MRS [Time frame: From enrollment to the end of treatment at 2-3 weeks]
- SF-36 [Time frame: From enrollment to the end of treatment at 2-3 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Samara Regional Clinical Hospital named after V.D. Seredavin — Samara
Identifiers
NCT: NCT06753006 · NT-STROKE-2024-09