Virtual Reliability System for Visual Spatial Attention Evaluation in Stroke Patients

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatient and inpatient rehabilitation unit in a medical center

Description

Inclusion Criteria for stroke patients:

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

Inclusion criteria for control group:

1) healthy adults, age-matched to stroke patients

Exclusion Criteria for both groups:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADL	activities of daily living function evaluated by barthel index	4 weeks
cognition	using Montreal Cognitive Assessment (MoCA)	4 weeks
cybersickness	using Simulator Sickness Questionnaire (SSQ)	1 day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Huey-Wen Liang, MD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: virtual reality; attention; reaction time; hemineglect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Stroke; Perceptual Disorders
• Other Study ID Numbers: 202104030RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No