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| Name | Class |
|---|---|
| Samara State Medical University | OTHER |
| Samara Regional Clinical Hospital V.D. Seredavin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
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| MI+VR | Experimental | 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. |
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| MI2+VR | Experimental | 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. |
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| MI2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurorehabilitation simulator | Device | The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb. |
| Measure | Description | Time Frame |
|---|---|---|
| FMA-UE A-D | 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. | From enrollment to the end of treatment at 2-3 weeks |
| ARAT | 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. | From enrollment to the end of treatment at 2-3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS | 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. | From enrollment to the end of treatment at 2-3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ICF | 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 | From enrollment to the end of treatment at 2-3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Bulanov | Contact | +79272081176 | vb@ntech.team | |
| Alexander Zakharov, Ph.D. | Contact | +79171620301 |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Zakharov, Ph.D. | Samara State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samara Regional Clinical Hospital named after V.D. Seredavin | Recruiting | Samara | Samara Oblast | 443095 | Russia |
Only authorized members of the research team will have access to individual participant data (IPD). The research team will not share any IPD with third parties. However, de-identified demographic and clinical data-such as treatment details, baseline characteristics, and outcome measures-will be made publicly available.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants will be randomly assigned to either one of three experimental groups or a control group.
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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.
| Standard course | Procedure | The participant receives a standard course of intervention as prescribed by the attending physician in accordance |
|
| Ashworth | 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. | From enrollment to the end of treatment at 2-3 weeks |
| RMI | 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. | From enrollment to the end of treatment at 2-3 weeks |
| MRS | 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. | From enrollment to the end of treatment at 2-3 weeks |
| SF-36 | 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. | From enrollment to the end of treatment at 2-3 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |