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Completed

NCT Number: NCT05145699

A Pilot Study on the Feasibility Study of a Novel Virtual Reality (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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VR-based post-stroke hemineglect evaluation system

Device

Evaluation system applied with virtual environment using Pico Neo 2 eye

Primary outcomes

  1. 8 items of virtual reality-based hemineglect evaluation system

    Time frame: up to 1 year

    (1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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