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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05145699
Enrollment
43
Registered
2021-12-06
Start date
2021-08-31
Completion date
2023-12-31
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Complication

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.

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.

Interventions

DEVICEVR-based post-stroke hemineglect evaluation system

Evaluation system applied with virtual environment using Pico Neo 2 eye

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
8 items of virtual reality-based hemineglect evaluation systemup to 1 year(1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026