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Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05309148
Enrollment
50
Registered
2022-04-04
Start date
2022-01-10
Completion date
2024-12-20
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Disturbances, Oculomotor; Disorder, Stroke

Keywords

Eye tracking, Visual feedback, Cognitive functions, Rehabilitation

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).

Interventions

BEHAVIORALTraining 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.

BEHAVIORALTraining with a neuropsychologist

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

BEHAVIORALTraining on eye tracker based device and with a neuropsychologist

This is combination of the first and second interventions

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

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);

Design outcomes

Primary

MeasureTime frameDescription
Consciousness TestChange from baseline at 2 weeksIt 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 scaleChange from baseline at 2 weeksDiagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: language scaleChange from baseline at 2 weeksDiagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: visual-spatial scaleChange from baseline at 2 weeksDiagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: communicative scaleChange from baseline at 2 weeksDiagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: thinking skills scaleChange from baseline at 2 weeksDiagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Assessment of a neuropsychologistChange from baseline at 2 weeksScreening 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

Countries

Russia

Contacts

Primary ContactGalina Ivanova, Prof
reabilivanova@mail.ru+7(499) 280-35-50
Backup ContactAlina Aizenshtein
alinaaiz@yandex.ru+79104082769

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026