Clinical trial NCT04651335: Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
Official title: Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Neglect
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and analyze how the visual gaze training in the afferent direction and the visual gaze training in the efferent direction using virtual reality affects the improvement of the neglect phenomenon in patients with subacute stroke with unilateral neglect.

Based on the behavioral intention test (BIT) test and the Mini-Mental Screening Examination test (MMSE) test for the group of unilateral neglected patients with stroke findings among all eligible patients for this experiment.

Appropriate subjects are selected and randomly divided into two groups. One group uses an afferent virtual reality program, and the other uses an efferent virtual reality program to train five times a week for a total of 4 weeks.

Before training, a computer experience scale 21 was additionally performed, and to find out the degree of unilateral negligence, evaluation was performed using the Behavioral Inattention Test (BIT) and Catherine Bergego Scale (CBS)22, and the angle of deflection (deviation angle), out-of-focus time, gaze time, failure rate, and head rotation trajectory were evaluated. In addition, reaction time, failure rate, and head rotation trajectory were evaluated using a virtual reality program (Assessment program-V2) to evaluate the degree of unilateral negligence. After that, BIT, CBS, and Assessment program-V2 tests are performed to determine the degree of improvement in visual ignorance due to each program.


Eligibility criteria: Inclusion Criteria:

1. A person with left hemiplegia who was found to have a stroke by MRI or CT.
2. A person who has been confirmed to have unilateral neglect (BIT 196 or less, or each subtest cut off or less)
3. A person who has enough cognitive ability to receive virtual reality training. (In case of more than 20 points in MMSE)
4. Those within 3 months of onset.

Exclusion Criteria:

1. Those with a history of recurring brain damage
2. hemianopsia
3. When there is a disorder in the movement of the neck due to orthopedic problems
4. Someone has vision and hearing problems during evaluation and treatment
5. difficult to maintain a sitting position in a chair with back and armrests
6. other diseases that may affect your general cognitive decline
7. who disagree with this study

Primary outcomes:
measure: Behavioral Inattention Test (BIT)
timeFrame: before treatment
measure: Behavioral Inattention Test (BIT)
timeFrame: 2weeks
measure: Behavioral Inattention Test (BIT)
timeFrame: 4weeks
measure: Behavioral Inattention Test (BIT)
timeFrame: 4weeks after end of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Deog Young Kim
role: PRINCIPAL_INVESTIGATOR
References: