Rehabilitation Methods for Unilateral Spatial Neglect in Stroke Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

About this trial

Stroke remains one of the leading causes of mortality and disability worldwide. Between 30% and 40% of patients who have had an acute cerebral hemorrhage, develop unilateral spatial neglect syndrome (USN).

USN is observed in 24% of patients with left-hemispheric stroke and 45% of patients with right-hemispheric lesions in the acute phase acute phase and in 20% of patients in the chronic phase.

The presence of USN significantly complicates the rehabilitation process and negatively affects the functional outcomes. The complexity of USN correction is due to the heterogeneity of its manifestations and combination with other cognitive disorders. In 30-50% of patients with USN anosognosia is observed, in 60% - memory and attention disorders.

Traditional methods of rehabilitation lead to significant improvement in 30-50% of patients with USN. The use of combined methods of treatment, including pharmacotherapy and non-medication methods, can improve efficacy by up to 70-80%. This indicates the need to develop and investigate new approaches to correct USN.

Despite the growing number of studies in this area, there is still no unified approach to selecting the optimal method of USN correction for each individual patient.

Different methods of rehabilitation may have different effects on neuroplasticity processes, which opens new perspectives for optimization of rehabilitation strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Normal cognitive development in accordance with age and educational level;

diagnosis with codes I63, I61 (ICD);

presence of unilateral spatial neglect syndrome in the neuropsychological status.

Disqualifiers

presence of mental and somatic pathology of severe degree and in decompensation stage;

the presence of gross oculomotor disorders;

presence of a sensory visual defect of moderate to severe severity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional therapy

    Behavioral

    The methods of traditional neuropsychological rehabilitation used in the classes included: * attention tasks: proofreading tests, Schulte's Table; * spatial thinking tasks: copying, drawing, tasks using Nikitin cubes; * text reading tasks: texts from the Luria album. Each session began with oculomotor exercises. The correction programs differed by the type of feedback given to the patient in the course of correction. Feedback in this type of intervention is in the form of prompts from a specialist.

  • Eye tracking based therapy

    Behavioral

    Rehabilitation in this group was carried out using an alternative communication device - oculograph C-Eye Pro (Assistech). The use of the device is characterized by a number of features: the presence of the eye movement biofeedback function (the patient and the specialist can see where the patient's gaze is directed by the movement of the red dot on the screen), the device needs to be pre-calibrated before the beginning of the session. To implement rehabilitation activities such tasks were used as: * Visual field training; * Word composing; * Vowel insertion; * Reading; * etc. The peculiarity of correction on the apparatus of alternative communication - oculograph - was the use of visual biological communication, visual biological communication, also in case of wrong answer a sound signal followed.

  • Cognitive therapy

    Behavioral

    Rehabilitation of patients in the second experimental group was carried out on the RehaCom modular therapeutic system. The modular system includes a dedicated keyboard that has: numbers 1-9, 4 ok buttons, 4 arrow buttons, 2 pause/tip buttons and 2 exit/cancel buttons. Most of the tasks are performed using the keyboard, some of the tasks involved touch screen control. Tasks with stimulus images in the left screen space were used for rehabilitation activities: * "Saccades"; * "Attention and Concentration"; * "Planar Imagination"; * "General Presentation and Reading"; * "Shopping"; * "Daily routine". A feature of the correction on the modular therapy system was the involvement of a motor component, playing a sound cue or visual cue when an error occurred.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Conventional groupActive comparator 1 intervention
Group B: Eye tracker groupExperimental treatment 1 intervention
Group C: Cognitive training groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual search for objects in the left and right hemifield among distractors

The visual search task is aimed at determining the latent search time for subject images (soccer ball, blue suitcase, potatoes in a glass) among a large number of distractors. The test is also performed on a C-Eye II Pro. The test procedure starts with recalibration, with a total of 5 calibration points. The test utilizes the visual biofeedback function - the specialist and the subject can observe the gaze movement of the patient. At the Measurement compared to baseline after 2 weeks beginning of the test, the patient is asked to scrutinize the appeared picture (target and distractor images appear on the screen at the same time) for 30 seconds. After that, the patient should fix his or her gaze on the image of a white question mark in the center of the screen. Next, search tasks are given to find: soccer ball, red felt-tip pen, blue suitcase, green light bulb, planet earth, fries in a glass. The patient's task was to find all target objects in less than 25 seconds from a fixed point.

Time frame
Measurement compared to baseline after 2 weeks

Secondary outcomes

1

Albert test

The line-drawing test aims to estimate the latent search time of stimuli, to quantify the missed stimuli according to their location on the sheet. The test involves the presentation of a sheet with 40 lines, 2.5 minutes long, organized in 6 rows of 6 lines and one row of 5 lines. Accordingly, there are 18 lines on the right and left and 5 on the left. The patient's task is to cross out all the lines as quickly as possible (after 5 minutes the test is interrupted). Processing of the test results: the maximum number of points is 41, which means that the examinee found all the bells. Indicative in interpreting the results of parameter tests is the percentage of line skips in the left half of the sheet from the total number of skips. Thus, if more than 70% are recorded, we can assume the development of visual inattention

Time frame
Measurement compared to baseline after 2 weeks
2

Bell's Test

The is aimed at estimating the latent search time of stimuli, at quantifying the missed stimuli depending on their location on the sheet. An important feature of the test is the presence of distractors in the stimulus material. Initially, the subject is presented with a "demonstration" sheet containing an enlarged version of each of the distractors and one circled bell. As part of the test, a sheet showing a large number of small black images is presented, among which 35 bells are distributed in 7 columns. In total there are 3 columns on the right and left and one in the center. The patient's task is to cross out all the bells as quickly as possible. Processing of the test results: the maximum number of points is 35, which means that the subject found all the bells. If the patient makes more than 3 omissions, we can talk about possible attention deficit, but if the number of omissions is more than 6, it indicates signs of visual inattention.

Time frame
Measurement compared to baseline after 2 weeks
3

Line bisection test

The test is aimed at determining the degree of displacement of the subjective center. The test involves the presentation of 20 horizontal lines of different lengths. The first and last lines are demonstration lines, on which the specialist demonstrates the instruction and independently places a vertical mark in the center of each line. The 18 stimulus lines are divided into three blocks according to their location on the sheet: 6 on the left, in the center and on the right. The task of the test subject is to mark the center on each of the lines. The test results were processed according to the formula proposed by Schenkenberg to get the % offset of the center mark. A negative value indicates a leftward shift, a positive value indicates a rightward shift Interpretation. The left and center lines are significant for the analysis. Thus, if the mean value for left line blocks is \> 7% and for center line blocks \> 5%, we can assume the development of neglect syndrome

Time frame
Measurement compared to baseline after 2 weeks
4

Test of complex competitive stimulation in both visual hemifields

The test is aimed at determining the latent search time of stimuli located in both visual fields among distractors. The test is performed on C-Eye II Pro. The test utilizes the visual biofeedback function - the technician and the subject can observe the gaze movement of the patient. As part of the test, the test taker is initially presented with a demonstration sheet depicting all of the figures demonstrated in the test. The subject is asked to name only one figure, for a total of 8 figures. Then there are 12 presentations of figures in different numbers and positions relative to each other: no less than 1 and no more than 3 figures are displayed on the screen at the same time, before each presentation the patient is shown a blue circle located in the center. The patient's task is to find the figures on the screen, look at them, and name them. If the subject searches for a figure for longer than 25 seconds, the specialist proceeds to the next presentation.

Time frame
Measurement compared to baseline after 2 weeks

Other outcomes

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