Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Status: Enrolling

Conditions: Oculomotor; Disorder; Stroke; Attention Disturbances

Treatments: Behavioral: Training on eye tracker based device; Behavioral: Training on eye tracker based device and with a neuropsychologist; Behavioral: Training with a neuropsychologist

Study type: Interventional

Funder types: Other

Identifiers

NCT05309148

Eye001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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);

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups

Training on eye tracker based device

Experimental group

Description:

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).

Treatment:

Behavioral: Training on eye tracker based device

Training with a neuropsychologist

Active Comparator group

Description:

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.

Treatment:

Behavioral: Training with a neuropsychologist

Training on eye tracker based device and with a neuropsychologist

Active Comparator group

Description:

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.

Treatment:

Behavioral: Training on eye tracker based device and with a neuropsychologist