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

NCT05145699 | Completed

• 1 other identifier: B-2108-705-302
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Right hemispheric stroke with hemineglect

EXPERIMENTAL

Device: VR-based post-stroke hemineglect evaluation system

Right hemispheric stroke without hemineglect

ACTIVE COMPARATOR

Device: VR-based post-stroke hemineglect evaluation system

Normal people

OTHER

Device: VR-based post-stroke hemineglect evaluation system

Interventions

VR-based post-stroke hemineglect evaluation system DEVICE

Evaluation system applied with virtual environment using Pico Neo 2 eye

Normal people; Right hemispheric stroke with hemineglect; Right hemispheric stroke without hemineglect

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nam-Jong Paik, Ph.D

  Seoul National University Bundang Hospital, Seongnam, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 6, 2021
• Study Start: August 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

KR (1)