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

Stroke, Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145699
• Other study ID #: B-2108-705-302
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Seoul National University Bundang Hospital
• Contact: Nam-Jong Paik, Ph.D
• Phone: 82-31-787-7731
• Email: njpaik[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Complication

Intervention

Device:
• VR-based post-stroke hemineglect evaluation system
Evaluation system applied with virtual environment using Pico Neo 2 eye

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 1 year