Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cognitive function scale: language scale
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
After a stroke, a wide range of neurological disorders can occur. One of them is impairments of the visual-oculomotor system in 8-31% of cases. Such patients experience loss of visual fields, hemianopia, tunnel vision, diplopia. All this causes great difficulties for returning to everyday life, as well as to professional activity. The eye tracking method allows to diagnose and evaluate the effectiveness of training aimed at improving the functioning of the saccadic system, reducing the volume of visual deficit. Currently, eye tracking is represented by a variety of technological solutions, but not all of them are used in the clinic. The aim of the study is the application of an eye tracking-based device in cerebral stroke survivors for the correction of oculomotor disorders and visual attention functions. Stroke patients participate in the study in Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency, Moscow, Russia. The study has been conducted since January, 10 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stay in a 24-hour hospital and undergo a rehabilitation course. For 3 weeks, patients receive daily training on the C-Eye Pro device, AssisTech Sp. z. o. o, Poland. The patients interact with the device only by using eye movements. Participants undergo a primary assessment of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions). According to the results of the diagnosis, participants are offered a scheme of correctional training and secondary assessment at the end of the training. Correction training consists, firstly, of 10-minute exercise at the beginning of each session, aimed at improving visual functions and attention. Patients have to follow the spontaneously moving object. The result is evaluated qualitatively using heat and scanpath maps. Secondly, the correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in assessment).
Investigators
Eligibility Criteria
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);
Outcomes
Primary Outcomes
Cognitive function scale: language scale
Time Frame: Change from baseline at 2 weeks
Diagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Consciousness Test
Time Frame: Change from baseline at 2 weeks
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.
Cognitive function scale: communicative scale
Time Frame: Change from baseline at 2 weeks
Diagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: memory scale
Time Frame: Change from baseline at 2 weeks
Diagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance
Assessment of a neuropsychologist
Time Frame: Change from baseline at 2 weeks
Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)
Cognitive function scale: thinking skills scale
Time Frame: Change from baseline at 2 weeks
Diagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: visual-spatial scale
Time Frame: Change from baseline at 2 weeks
Diagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance