Virtual Reliability System for Visual Spatial Attention Evaluation in Stroke Patients

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05332964

Collaborator

(none)

200

Enrollment

Location

16.2

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The researchers designed a software based on a head-mounted displays for virtual reality (HMD-VR) to evaluate the reaction time to stimuli presented at right or left visual field. The study will recruit 100 stroke patients with hemisphere lesions (50 patients for right and left each) and 100 age-matched healthy controls. The participants will conduct a simple reaction time task in VR, with stimuli designated in the left or right hemi-field. The stroke patients will also received traditional tests for hemi-neglect. Test-retest reliability of the assessment will be conducted in a subset of the control group. The stroke patients will be followed in 3-4 weeks.

Condition or Disease	Intervention/Treatment	Phase
Stroke Sequelae Neglect, Hemispatial

Detailed Description

The researchers designed a software based on a head-mounted displays for virtual reality (HMD-VR) to evaluate the reaction time to stimuli presented at right or left visual field. The study will recruit 100 stroke patients with hemisphere lesions (50 patients for right and left hemisphere each) and 100 age-matched healthy controls. The participants will conduct a simple reaction time task in VR, with stimuli designated in the left or right hemi-field. The stroke patients will also receive traditional tests for hemi-neglect. The researchers will also collect the demographic data, cognition function and daily activity function. Test-retest reliability of the assessment will be conducted in a subset of the control group. The stroke patients will be followed in 3-4 weeks. The researchers will compare the results of a traditional hemi-neglect tests and VR-based tests and their changes in two occasions.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Application of a Virtual Reliability System in the Evaluation of the Visual Spatial Attention in Stroke Patients

Actual Study Start Date :

Aug 24, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
stroke (right) stroke patient with lesions at right hemisphere
stroke (left) stroke patient with lesions at left hemisphere
control age-matched group for the stroke patients

Outcome Measures

Primary Outcome Measures

reaction time [4 weeks]
reaction time to the stimuli presented in the right or left hemi-field with VR software
hemineglect tests [4 weeks]
Paper-based behavior inattention test (BIT)

Secondary Outcome Measures

ADL [4 weeks]
activities of daily living function evaluated by barthel index
cognition [4 weeks]
using Montreal Cognitive Assessment (MoCA)
cybersickness [1 day]
using Simulator Sickness Questionnaire (SSQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for stroke patients:

aged at least 20 years old
diagnosed with stroke involving unilateral MCA and ACA territory
with unilateral upper limb with normal function
neurologically and medically stable.

Inclusion criteria for control group:

healthy adults, age-matched to stroke patients

Exclusion Criteria for both groups:

with history of neurological or psychiatric conditions other than stroke;
significant cognitive or speech problems that cause difficulties to cooperate with testing;
significant visual problems (such as color blindness, visual loss, cataract, glaucoma or other major eye condition)
upper limb musculoskeletal disorders to cause difficulties to use the keyboard or controller;
history of seizure, vestibular dysfunction or vertigo
can't tolerate HMD-VR