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

NCT ID: NCT05145699

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2023-12-31

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.

Conditions

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Stroke, Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Right hemispheric stroke with hemineglect

Group Type EXPERIMENTAL

VR-based post-stroke hemineglect evaluation system

Intervention Type DEVICE

Evaluation system applied with virtual environment using Pico Neo 2 eye

Right hemispheric stroke without hemineglect

Group Type ACTIVE_COMPARATOR

VR-based post-stroke hemineglect evaluation system

Intervention Type DEVICE

Evaluation system applied with virtual environment using Pico Neo 2 eye

Normal people

Group Type OTHER

VR-based post-stroke hemineglect evaluation system

Intervention Type DEVICE

Evaluation system applied with virtual environment using Pico Neo 2 eye

Interventions

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VR-based post-stroke hemineglect evaluation system

Evaluation system applied with virtual environment using Pico Neo 2 eye

Intervention Type DEVICE

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nam-Jong Paik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nam-Jong Paik, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital, Seongnam, South Korea

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-2108-705-302

Identifier Type: -

Identifier Source: org_study_id

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