Clinical trial NCT05309148: Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients
Official title: Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Oculomotor; Disorder
Attention Disturbances
Keywords: Eye tracking
Visual feedback
Cognitive functions
Rehabilitation
Lead sponsor: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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);

Primary outcomes:
measure: Consciousness Test
timeFrame: Change from baseline at 2 weeks
measure: Cognitive function scale: memory scale
timeFrame: Change from baseline at 2 weeks
measure: Cognitive function scale: language scale
timeFrame: Change from baseline at 2 weeks
measure: Cognitive function scale: visual-spatial scale
timeFrame: Change from baseline at 2 weeks
measure: Cognitive function scale: communicative scale
timeFrame: Change from baseline at 2 weeks
measure: Cognitive function scale: thinking skills scale
timeFrame: Change from baseline at 2 weeks
measure: Assessment of a neuropsychologist
timeFrame: Change from baseline at 2 weeks
measure: Assessment of a neuropsychologist
timeFrame: Change from baseline at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Study officials:
affiliation: Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
name: Marina Shurupova, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: