Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
Primary Purpose
Stroke, Neglect
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
afferent virtual reality program
efferent virtual reality program
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Yonsei Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Concentric
Eccentric
Arm Description
uses an afferent virtual reality program
uses an efferent virtual reality program
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651335
Brief Title
Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
Official Title
Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2012 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neglect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concentric
Arm Type
Active Comparator
Arm Description
uses an afferent virtual reality program
Arm Title
Eccentric
Arm Type
Active Comparator
Arm Description
uses an efferent virtual reality program
Intervention Type
Device
Intervention Name(s)
afferent virtual reality program
Intervention Description
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
Intervention Name(s)
efferent virtual reality program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioral Inattention Test (BIT)
Description
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.
Time Frame
before treatment
Title
Behavioral Inattention Test (BIT)
Description
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.
Time Frame
2weeks
Title
Behavioral Inattention Test (BIT)
Description
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.
Time Frame
4weeks
Title
Behavioral Inattention Test (BIT)
Description
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.
Time Frame
4weeks after end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deog Young Kim
Phone
82-2-2228-3700
Email
KIMDY@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Phone
82-2-2228-3700
Email
KIMDY@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Concentric or Eccentric Virtual Reality Training Program in Subacute-stroke Patients With Hemispatial Neglect
We'll reach out to this number within 24 hrs