Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

NCT ID: NCT05309148

Last Updated: 2022-04-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-12-20

Brief Summary

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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

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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).

Conditions

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Stroke Oculomotor; Disorder Attention Disturbances

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

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).

Group Type EXPERIMENTAL

Training on eye tracker based device

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Training with a neuropsychologist

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Training on eye tracker based device and with a neuropsychologist

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Training with a neuropsychologist

The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)

Intervention Type BEHAVIORAL

Training on eye tracker based device and with a neuropsychologist

This is combination of the first and second interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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);
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Galina Ivanova, Prof

Role: CONTACT

+7(499) 280-35-50

Alina Aizenshtein

Role: CONTACT

+79104082769

Facility Contacts

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Galina Ivanova, Prof

Role: primary

Alina Aizenshtein

Role: backup

Other Identifiers

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Eye001

Identifier Type: -

Identifier Source: org_study_id

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