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

November 25, 2020 updated by: Yonsei University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Deog Young Kim
  • Phone Number: 82-2-2228-3700
  • Email: KIMDY@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei Severance Hospital
        • Contact:
          • Deog Young Kim
          • Phone Number: 82-2-2228-3700
          • Email: KIMDY@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Concentric
uses an afferent virtual reality program
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.
Active Comparator: Eccentric
uses an efferent virtual reality program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behavioral Inattention Test (BIT)
Time Frame: before treatment
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)
Time Frame: 2weeks
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)
Time Frame: 4weeks
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)
Time Frame: 4weeks after end of the treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2012-0416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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