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

NCT04651335 | Unknown

• 1 other identifier: 4-2012-0416
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Neglect

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Concentric

ACTIVE COMPARATOR

uses an afferent virtual reality program

Device: afferent virtual reality program

Eccentric

ACTIVE COMPARATOR

uses an efferent virtual reality program

Device: efferent virtual reality program

Interventions

afferent virtual reality program DEVICE

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.

Concentric

efferent virtual reality program DEVICE

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.

Eccentric

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A person with left hemiplegia who was found to have a stroke by MRI or CT.
• A person who has been confirmed to have unilateral neglect (BIT 196 or less, or each subtest cut off or less)
• A person who has enough cognitive ability to receive virtual reality training. (In case of more than 20 points in MMSE)
• Those within 3 months of onset.

You may not qualify if:

• Those with a history of recurring brain damage
• hemianopsia
• When there is a disorder in the movement of the neck due to orthopedic problems
• Someone has vision and hearing problems during evaluation and treatment
• difficult to maintain a sitting position in a chair with back and armrests
• other diseases that may affect your general cognitive decline
• who disagree with this study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Deog Young Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

82-2-2228-3700; KIMDY@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: August 9, 2012
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)