Clinical trial NCT05145699: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Complication
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: 8 items of virtual reality-based hemineglect evaluation system
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital, Seongnam, South Korea
name: Nam-Jong Paik, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: