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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Complication
• Intervention / Treatment: Device: VR-based post-stroke hemineglect evaluation system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Nam-Jong Paik, Ph.D, Seoul National University Bundang Hospital, Seongnam, South Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: B-2108-705-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No