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Clinical Trials/NCT05309148
NCT05309148
Recruiting
Not Applicable

Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health1 site in 1 country50 target enrollmentJanuary 10, 2022

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).

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
December 20, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

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

Study Sites (1)

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