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临床试验/NCT05309148
NCT05309148招募中不适用

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 Health2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Cognitive function scale: language scale

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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);

排除标准

  • 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);

结局指标

主要结局

Cognitive function scale: language scale

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

Cognitive function scale: thinking skills scale

时间窗: 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

时间窗: 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

Assessment of a neuropsychologist

时间窗: Change from baseline at 2 weeks

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

次要结局

未报告次要终点

研究者

发起方
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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