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

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Seoul National University

Status

Completed

Conditions

Stroke, Complication

Treatments

Device: VR-based post-stroke hemineglect evaluation system

Study type

Interventional

Funder types

Other

Identifiers

NCT05145699
B-2108-705-302

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 3 patient groups

Right hemispheric stroke with hemineglect
Experimental group
Treatment:
Device: VR-based post-stroke hemineglect evaluation system
Right hemispheric stroke without hemineglect
Active Comparator group
Treatment:
Device: VR-based post-stroke hemineglect evaluation system
Normal people
Other group
Treatment:
Device: VR-based post-stroke hemineglect evaluation system

Trial contacts and locations

1

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Central trial contact

Nam-Jong Paik, Ph.D

Data sourced from clinicaltrials.gov

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