A Comparative Analysis of Methods for Rehabilitation of Unilateral Spatial Neglect (USN) in Stroke Patients: Conventional Therapy, Computerized Cognitive Training and Eye Movement Biofeedback Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Visual search for objects in the left and right hemifield among distractors
Study Overview
Brief Summary
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.
Detailed Description
Stroke remain one of the leading causes of death and disability worldwide. According to the World Health Organization, about 15 million cases of stroke are registered annually, of which 5 million are fatal and another 5 million result in permanent disability.
In Russia, about 450 thousand cases of stroke are registered annually, with a mortality rate of about 35% during the first year after stroke. The frequency of ischemic strokes is 80-85%, hemorrhagic strokes - 15-20%.
According to the localization of the lesion, strokes in the middle cerebral artery basin are the most common (up to 50-60% of cases), followed by strokes in the vertebrobasilar basin (20-25%) and the anterior cerebral artery basin (10-15%).
Disability after a stroke is observed in 70-80% of surviving patients, with about 20-30% requiring constant nursing care.
Neuro-ophthalmologic disorders develop in 40-60% of cases in patients who have undergone stroke, while sensory inattention develops in 30-40% of cases. Sensory inattention, or neglect syndrome, is a manifestation of optic-spatial gnostic disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Conventional group
Patients with prescribed traditional neuropsychological rehabilitation. The rehabilitation program consisted of 6-10 sessions. On average, one session lasted 25-30 minutes, which was also limited by inpatient conditions (no correctional sessions with a neuropsychologist longer than 30 minutes) and the patient's fatigue.
Intervention: Conventional therapy (Behavioral)
Eye tracker group
Patients with assigned rehabilition to the alternative communication device - oculograph C Eye Pro (Assistech). The correctional program consisted of 6-10 sessions. On average, one session lasted 25-30 minutes, which was also limited by inpatient conditions (no correctional sessions with a neuropsychologist longer than 30 minutes) and patient fatigue.
Intervention: Eye tracking based therapy (Behavioral)
Cognitive training group
Patients with assigned rehabilitation on the RehaCom modular therapy system (HASOMED GmbH;). The rehabilitation program consisted of 6-10 sessions. One session lasted 25-30 minutes, which was also limited by inpatient conditions (no correctional sessions with a neuropsychologist longer than 30 minutes) and the patient's fatigue.
Intervention: Cognitive therapy (Behavioral)
Outcomes
Primary Outcomes
Visual search for objects in the left and right hemifield among distractors
Time Frame: Measurement compared to baseline after 2 weeks
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.
Secondary Outcomes
- Test of complex competitive stimulation in both visual hemifields(Measurement compared to baseline after 2 weeks)
- Albert test(Measurement compared to baseline after 2 weeks)
- Bell's Test(Measurement compared to baseline after 2 weeks)
- Line bisection test(Measurement compared to baseline after 2 weeks)
Investigators
Mikhail Soldatov
Dr
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health