A Pilot Study on the Feasibility Study of a Novel Virtual Reality (VR)-Based Post-stroke Hemineglect Evaluation System

Study Overview
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Brief Summary
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The normal value of the new virtual reality (VR)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. And, the usability of the virtual reality-based hemineglect evaluation system is confirmed.

Detailed Description
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This pilot study included 50 stroke patients with right hemisphere lesion and 25 healthy people. The normal value for each item is determined based on the result value for each item of the virtual reality (VR)-based hemineglect evaluation system in normal people. It is checked whether there is a difference in the results measured using the VR-based hemineglect evaluation system in normal persons, stroke patients with hemineglect, and stroke patients without hemineglect. Structural validity is confirmed by examining the correlation between the measured values of the virtual VR-based hemineglect evaluation system and Korean Version of Modified Barthel Index (K-MBI), Mini Mental State Examination (MMSE), and Behavioral Inattention Test-Conventional (BIT-C) in stroke patients with hemineglect. Check the required time and test stability of the evaluation using the VR-based hemineglect evaluation system.

Official Title
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A Pilot Study on the Feasibility Study of a Novel VR-based Post-stroke Hemineglect Evaluation System

Conditions
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Stroke, Complication

Intervention / Treatment
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* Device: VR-based post-stroke hemineglect evaluation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (Stroke patients) Right handed Patients with first onset stroke, with right brain lesions confirmed by imaging tests (MRI, CT) Onset of stroke more than 1week (Normal people) Right handed Who has no problem in identifying objects with wearing VR head gear. Exclusion Criteria: (Stroke patients) Patients with unilateral neglect due to other causes. Patients with neurological diseases other than stroke (Parkinson's disease, Alzheimer's disease, etc.) Patients with severe cognitive impairment. Patients with underlying diseases or medical history that may cause visual impairment. (Normal people) Who has a neurological disease such as stroke, traumatic brain injury, Parkinson's disease, or Alzheimer's disease. Who has a severe cognitive impairment. Who has a underlying diseases or medical history that may cause visual impairment.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right hemispheric stroke with hemineglect<br> | Device: VR-based post-stroke hemineglect evaluation system<br>* Evaluation system applied with virtual environment using Pico Neo 2 eye<br>|
| Active Comparator: Right hemispheric stroke without hemineglect<br> | Device: VR-based post-stroke hemineglect evaluation system<br>* Evaluation system applied with virtual environment using Pico Neo 2 eye<br>|
| Other: Normal people<br> | Device: VR-based post-stroke hemineglect evaluation system<br>* Evaluation system applied with virtual environment using Pico Neo 2 eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8 items of virtual reality-based hemineglect evaluation system | (1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL) | up to 1 year |