Virtual Reliability System for Visual Spatial Attention Evaluation in Stroke Patients

Stroke Sequelae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05332964
• Other study ID #: 202104030RINC
• Status: Enrolling by invitation
• Start date: August 24, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neglect, Hemispatial
• Perceptual Disorders
• Stroke
• Stroke Sequelae

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reaction time	reaction time to the stimuli presented in the right or left hemi-field with VR software	4 weeks
Primary	hemineglect tests	Paper-based behavior inattention test (BIT)	4 weeks
Secondary	ADL	activities of daily living function evaluated by barthel index	4 weeks
Secondary	cognition	using Montreal Cognitive Assessment (MoCA)	4 weeks
Secondary	cybersickness	using Simulator Sickness Questionnaire (SSQ)	1 day