Stroke Clinical Trial
Official title:
Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke
Investigators will test the effectiveness of oculomotor cognitive training using eye tracker-based device during rehabilitation course in patients with a degree of disability no more than 3 points on a scale Rankin.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 20, 2024 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: - signed consent - at least 3 points on the Rankin scale; - the presence of disorders of the visual-oculomotor system, visual attention; - understanding and following instructions; stable vegetative and hemodynamic parameters; - on the MOOCA scale >22; - patients should be fully examined for the underlying and concomitant disease (examination by a neurologist, ophthalmologist, physiotherapist); Exclusion Criteria: - 4, 5 points on the Rankin scale; - unstable hemodynamics; - time after stroke is less than 2 weeks; - presence of epileptic activity; - serious ophthalmological disorders (for example, partial atrophy of the optic nerve); |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consciousness Test | It is necessary to monitor the emerging stimuli (red circles) and keep eyes in the center of each of them. The quantitative indicator of visual attention as a percentage will be measured. | Change from baseline at 2 weeks | |
Primary | Cognitive function scale: memory scale | Diagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance | Change from baseline at 2 weeks | |
Primary | Cognitive function scale: language scale | Diagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance | Change from baseline at 2 weeks | |
Primary | Cognitive function scale: visual-spatial scale | Diagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance | Change from baseline at 2 weeks | |
Primary | Cognitive function scale: communicative scale | Diagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance | Change from baseline at 2 weeks | |
Primary | Cognitive function scale: thinking skills scale | Diagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance | Change from baseline at 2 weeks | |
Primary | Assessment of a neuropsychologist | Screening for cognitive impairment: MoCA (Montreal Cognitive Assessment), the results vary between 0 and 30 points. A score of 26 points or more is considered the norm. The lower the score, the worse the result | Change from baseline at 2 weeks | |
Primary | Assessment of a neuropsychologist | Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery) | Change from baseline at 2 weeks |
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