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

NCT ID: NCT04651335

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-09

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concentric

uses an afferent virtual reality program

Group Type ACTIVE_COMPARATOR

afferent virtual reality program

Intervention Type 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.

Eccentric

uses an efferent virtual reality program

Group Type ACTIVE_COMPARATOR

efferent virtual reality program

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deog Young Kim

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Yonsei Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Deog Young Kim

Role: CONTACT

Phone: 82-2-2228-3700

Email: [email protected]

Facility Contacts

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Deog Young Kim

Role: primary

Other Identifiers

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4-2012-0416

Identifier Type: -

Identifier Source: org_study_id