Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect

Stroke Clinical Trial

Official title:

Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651335
• Other study ID #: 4-2012-0416
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2012
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: 82-2-2228-3700
• Email: KIMDY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare and analyze how the visual gaze training in the afferent direction and the visual gaze training in the efferent direction using virtual reality affects the improvement of the neglect phenomenon in patients with subacute stroke with unilateral neglect. Based on the behavioral intention test (BIT) test and the Mini-Mental Screening Examination test (MMSE) test for the group of unilateral neglected patients with stroke findings among all eligible patients for this experiment. Appropriate subjects are selected and randomly divided into two groups. One group uses an afferent virtual reality program, and the other uses an efferent virtual reality program to train five times a week for a total of 4 weeks. Before training, a computer experience scale 21 was additionally performed, and to find out the degree of unilateral negligence, evaluation was performed using the Behavioral Inattention Test (BIT) and Catherine Bergego Scale (CBS)22, and the angle of deflection (deviation angle), out-of-focus time, gaze time, failure rate, and head rotation trajectory were evaluated. In addition, reaction time, failure rate, and head rotation trajectory were evaluated using a virtual reality program (Assessment program-V2) to evaluate the degree of unilateral negligence. After that, BIT, CBS, and Assessment program-V2 tests are performed to determine the degree of improvement in visual ignorance due to each program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

1. A person with left hemiplegia who was found to have a stroke by MRI or CT.

2. A person who has been confirmed to have unilateral neglect (BIT 196 or less, or each subtest cut off or less)

3. A person who has enough cognitive ability to receive virtual reality training. (In case of more than 20 points in MMSE)

4. Those within 3 months of onset.

Exclusion Criteria:

1. Those with a history of recurring brain damage

2. hemianopsia

3. When there is a disorder in the movement of the neck due to orthopedic problems

4. Someone has vision and hearing problems during evaluation and treatment

5. difficult to maintain a sitting position in a chair with back and armrests

6. other diseases that may affect your general cognitive decline

7. who disagree with this study

Related Conditions & MeSH terms

• Neglect
• Perceptual Disorders
• Stroke

Intervention

Device:
• afferent virtual reality program
When visual gaze training is applied to the left unilateral neglected patient, the gaze direction can be divided into an afferent direction closer to the body and an efferent direction away from the body. The concentric direction moves the ball from the left to the center of the body.
• efferent virtual reality program
When visual gaze training is applied to the left unilateral neglected patient, the gaze direction can be divided into an afferent direction closer to the body and an efferent direction away from the body. The efferent direction moves from the center to the right.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Inattention Test (BIT)	The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.	before treatment
Primary	Behavioral Inattention Test (BIT)	The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.	2weeks
Primary	Behavioral Inattention Test (BIT)	The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.	4weeks
Primary	Behavioral Inattention Test (BIT)	The Behavioral Inattention Test (BIT) is an objective behavioral test of everyday skills relevant to visual neglect, aimed at increasing the understanding of specific difficulties patients experience.	4weeks after end of the treatment