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Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

Primary Purpose

Stroke, Oculomotor; Disorder, Attention Disturbances

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Training on eye tracker based device
Training with a neuropsychologist
Training on eye tracker based device and with a neuropsychologist
Sponsored by
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Eye tracking, Visual feedback, Cognitive functions, Rehabilitation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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);

Sites / Locations

  • Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological AgencyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Training on eye tracker based device

Training with a neuropsychologist

Training on eye tracker based device and with a neuropsychologist

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

Consciousness Test
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: memory scale
Diagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: language scale
Diagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: visual-spatial scale
Diagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: communicative scale
Diagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: thinking skills scale
Diagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Assessment of a neuropsychologist
Screening for cognitive impairment: MoCA (Montreal Cognitive Assessment), the results vary between 0 and 30 points. A score of 26 points or more is considered the norm. The lower the score, the worse the result
Assessment of a neuropsychologist
Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
March 24, 2022
Sponsor
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05309148
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Oculomotor; Disorder, Attention Disturbances
Keywords
Eye tracking, Visual feedback, Cognitive functions, Rehabilitation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training on eye tracker based device
Arm Type
Experimental
Arm 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).
Arm Title
Training with a neuropsychologist
Arm Type
Active Comparator
Arm 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.
Arm Title
Training on eye tracker based device and with a neuropsychologist
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Training on eye tracker based device
Intervention Description
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
Intervention Name(s)
Training with a neuropsychologist
Intervention Description
The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)
Intervention Type
Behavioral
Intervention Name(s)
Training on eye tracker based device and with a neuropsychologist
Intervention Description
This is combination of the first and second interventions
Primary Outcome Measure Information:
Title
Consciousness Test
Description
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.
Time Frame
Change from baseline at 2 weeks
Title
Cognitive function scale: memory scale
Description
Diagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance
Time Frame
Change from baseline at 2 weeks
Title
Cognitive function scale: language scale
Description
Diagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Time Frame
Change from baseline at 2 weeks
Title
Cognitive function scale: visual-spatial scale
Description
Diagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Time Frame
Change from baseline at 2 weeks
Title
Cognitive function scale: communicative scale
Description
Diagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Time Frame
Change from baseline at 2 weeks
Title
Cognitive function scale: thinking skills scale
Description
Diagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Time Frame
Change from baseline at 2 weeks
Title
Assessment of a neuropsychologist
Description
Screening for cognitive impairment: MoCA (Montreal Cognitive Assessment), the results vary between 0 and 30 points. A score of 26 points or more is considered the norm. The lower the score, the worse the result
Time Frame
Change from baseline at 2 weeks
Title
Assessment of a neuropsychologist
Description
Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)
Time Frame
Change from baseline at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galina Ivanova, Prof
Phone
+7(499) 280-35-50
Email
reabilivanova@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Alina Aizenshtein
Phone
+79104082769
Email
alinaaiz@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Shurupova, Ph.D.
Organizational Affiliation
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
City
Moscow
ZIP/Postal Code
117513
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galina Ivanova, Prof
Email
reabilivanova@mail.ru
First Name & Middle Initial & Last Name & Degree
Alina Aizenshtein
Email
alinaaiz@yandex.ru
First Name & Middle Initial & Last Name & Degree
Marina Shurupova, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

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