Stroke, Stroke Acute, Stroke, Acute, Stroke, Acute, Ischemic, Stroke, Ischemic, Stroke with Hemiparesis
Conditions
Keywords
Stroke, Rehabilitation, Brain-Computer Interface, Motor Imagery, Robotics, Virtual Reality, Neurofeedback
Brief 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.
Interventions
DEVICENeurorehabilitation simulator
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
PROCEDUREStandard course
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
Sponsors
Samara State Medical University
Samara Regional Clinical Hospital V.D. Seredavin
Neurotechnika
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be evaluated by blinded assessors before being assigned to one of the study arms, and their rehabilitation outcomes will also be assessed by blinded assessors.
Intervention model description
Participants will be randomly assigned to either one of three experimental groups or a control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ARAT | From enrollment to the end of treatment at 2-3 weeks | The Action Research Arm Test (ARAT) evaluates a patient's ability to handle objects of various sizes, weights, and shapes, making it a specific measure of arm-related activity limitations. Scores range from 0 (indicating the most severe impairment) to 57 (indicating no impairment). Details available at https://strokengine.ca/en/assessments/action-research-arm-test-arat. |
| FMA-UE A-D | From enrollment to the end of treatment at 2-3 weeks | The Fugl-Meyer Assessment for Upper Extremity, parts A-D (FMA-UE A-D) evaluates a patient's motor function, with scores ranging from 0 (indicating the most severe impairment) to 66 (indicating no impairment). Details available at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ashworth | From enrollment to the end of treatment at 2-3 weeks | Dynamics according to the Ashworth Spasticity Scale that assesses a patient's spasticity in the range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Details available at https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale. |
| RMI | From enrollment to the end of treatment at 2-3 weeks | Dynamics according to the Rivermead Mobility Index (RMI) that assesses a patient's functional abilities such as gait, balance, and transfers in the range from 0 (worst mobility performance) to 15 (best mobility performance). Details available at https://strokengine.ca/en/assessments/rivermead-mobility-index-rmi. |
| SF-36 | From enrollment to the end of treatment at 2-3 weeks | The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Scores range from 0 (maximum disability) to 100 (no disability). Details available at https://nexusipe.org/advancing/assessment-evaluation/short-form-sf-36-health-survey. |
| MRS | From enrollment to the end of treatment at 2-3 weeks | Dynamics according to the Modified Rankin Scale (MRS) that assesses a patient's level of functional independence in the range from 0 (no symptoms) to 5 (severe disability). Details available at https://strokengine.ca/en/assessments/modified-rankin-scale-mrs. |
| NIHSS | From enrollment to the end of treatment at 2-3 weeks | Dynamics according to the National Institutes of Health Stroke Scale (NIHSS) that assesses a stroke patient's neurological impairment and degree of recovery for patients with stroke in the range from 0 (no impairment) to 42 (very severe impairment). Details available at https://strokengine.ca/en/assessments/nihss. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICF | From enrollment to the end of treatment at 2-3 weeks | The International Classification of Functioning, Disability and Health, known more commonly as ICF, is a classification of health and health-related domains. The ICF will be used to assess the impairment of body functions resulting from a stroke. Details available at https://www.who.int/standards/classifications/international-classification-of-functioning-disability-and-health |
Countries
Russia
Contacts
Primary ContactVladimir Bulanov
Backup ContactAlexander Zakharov, Ph.D.
Outcome results
None listed