Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients
NCT ID: NCT05309148
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-01-10
2024-12-20
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Training on eye tracker based device
Patients will undergo a primary diagnostics of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions) and an diagnostics of the visual attention index on an eye tracker-based device. Based on the results of the diagnosis, participants will be offered a scheme of correctional training and secondary diagnostics at the end of training. Correctional training on an eye tracker-based device consists, firstly, of a 10-minute exercise at the beginning of each lesson aimed at improving visual functions and attention. Patients had to follow a spontaneously moving object. Secondly, correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in the assessment).
Training on eye tracker based device
The intervention is based on the principle of visual biofeedback. The patient sees where his gaze is and can objectively assess and correct his visual error.
Training with a neuropsychologist
Patients will undergo primary and secondary diagnostics on an eye tracker-based device, then participants will have a conventional correctional training with a neuropsychologist according to an individual correction plan.
Training with a neuropsychologist
The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)
Training on eye tracker based device and with a neuropsychologist
Patients will undergo primary and secondary diagnostics and correctional training on an eye tracker-based device, in the same time participants will have a conventional correctional training with a neuropsychologist according to an individual correction plan.
Training on eye tracker based device and with a neuropsychologist
This is combination of the first and second interventions
Interventions
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Training on eye tracker based device
The intervention is based on the principle of visual biofeedback. The patient sees where his gaze is and can objectively assess and correct his visual error.
Training with a neuropsychologist
The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)
Training on eye tracker based device and with a neuropsychologist
This is combination of the first and second interventions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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);
30 Years
80 Years
ALL
Yes
Sponsors
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Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
OTHER
Responsible Party
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Principal Investigators
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Marina Shurupova, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Locations
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Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Eye001
Identifier Type: -
Identifier Source: org_study_id
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