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

Primary Purpose

Stroke, Complication

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
VR-based post-stroke hemineglect evaluation system
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke, Complication

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Right hemispheric stroke with hemineglect

Right hemispheric stroke without hemineglect

Normal people

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 11, 2021
Last Updated
September 7, 2022
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05145699
Brief Title
A Pilot Study on the Feasibility Study of a Novel Virtual Reality (VR)-Based Post-stroke Hemineglect Evaluation System
Official Title
A Pilot Study on the Feasibility Study of a Novel VR-based Post-stroke Hemineglect Evaluation System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Complication

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Right hemispheric stroke with hemineglect
Arm Type
Experimental
Arm Title
Right hemispheric stroke without hemineglect
Arm Type
Active Comparator
Arm Title
Normal people
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
VR-based post-stroke hemineglect evaluation system
Intervention Description
Evaluation system applied with virtual environment using Pico Neo 2 eye
Primary Outcome Measure Information:
Title
8 items of virtual reality-based hemineglect evaluation system
Description
(1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL)
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nam-Jong Paik, Ph.D
Phone
82-31-787-7731
Email
njpaik@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital, Seongnam, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Phone
82-031-787-7731
Email
njpaik@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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