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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04651335
Collaborator
(none)
44
1
2
123.7
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: afferent virtual reality program
  • Device: efferent virtual reality program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
Actual Study Start Date :
Aug 9, 2012
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral Inattention Test (BIT) [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.

  2. Behavioral Inattention Test (BIT) [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.

  3. Behavioral Inattention Test (BIT) [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.

  4. Behavioral Inattention Test (BIT) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yonsei Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Deog Young Kim, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04651335
Other Study ID Numbers:
  • 4-2012-0416
First Posted:
Dec 3, 2020
Last Update Posted:
Dec 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2020