Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality - Virtual Interactive Supermarket
Sponsored by

About this trial
This is an interventional diagnostic trial for Schizophrenia focused on measuring Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment
Exclusion Criteria:
- score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hospitalization patients
Ambulatory patients
Arm Description
patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)
patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)
Outcomes
Primary Outcome Measures
Modified 4 item test
"buy" 4 items with budget constraints, using the VIS
Secondary Outcome Measures
Revised Observed Tasks of Daily Living (OTDL-R)
evaluation of IADL using various tasks include problem solving
Executive Function Performance Test (EFPT)
executive function assessment using 5 different tasks
Trail Making Test A & B (TMT)
The Trail Making Test is an accessible neuropsychological instrument that provides the examiner with information on a wide range of cognitive skills and can be completed in 5-10 min.
The positive and negative syndrome scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) was developed out of the need for a well-operationalized method of assessing these syndromes in schizophrenia, including their relationship to one another and to global psychopathology
Adults Subjective Assessment of Participation
participation questionnaire that examine the level of engagement in different occupations
Full Information
NCT ID
NCT03146364
First Posted
April 1, 2017
Last Updated
May 6, 2017
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT03146364
Brief Title
Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia
Official Title
Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.
Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.
The results of the VIS shopping task performance (statically & dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.
Detailed Description
Background:
Schizophrenia often reflect by decrease in executive functions that may cause difficulty in Instrumental Activities of Daily Living (IADL). We've found it very difficult to simulate these functions with the existing tools in the clinic and to assess IADL accordingly.
The use of Virtual Reality (VR) became popular in the last decade to overcome these limitations in clinical practice and assessment of functioning in IADL. VR is a computer program that simulates a functional environment in which the subject impacts on events through various actions. Recent studies indicated that VR can be used to assess cognitive abilities and functioning of population with schizophrenia. As far as we know, no researches were performed using Virtual Interactive Shopping (VIS) in this population, nor did dynamic evaluation was used to identify potential learning abilities. The aim of this study is to examine the validity of the shopping task in the VIS, performed statically and dynamically, in order to assess executive function, and the ability to reflect cognitive, functional and participation ability among people that diagnosed with schizophrenia.
Method:
This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.
Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.
The results of the VIS shopping task performance (statically & dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Virtual Reality
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hospitalization patients
Arm Type
Experimental
Arm Description
patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)
Arm Title
Ambulatory patients
Arm Type
Experimental
Arm Description
patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)
Intervention Type
Device
Intervention Name(s)
Virtual Reality - Virtual Interactive Supermarket
Other Intervention Name(s)
SeeMe
Intervention Description
SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress.
Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction
Primary Outcome Measure Information:
Title
Modified 4 item test
Description
"buy" 4 items with budget constraints, using the VIS
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Revised Observed Tasks of Daily Living (OTDL-R)
Description
evaluation of IADL using various tasks include problem solving
Time Frame
through study completion, an average of 1 year
Title
Executive Function Performance Test (EFPT)
Description
executive function assessment using 5 different tasks
Time Frame
through study completion, an average of 1 year
Title
Trail Making Test A & B (TMT)
Description
The Trail Making Test is an accessible neuropsychological instrument that provides the examiner with information on a wide range of cognitive skills and can be completed in 5-10 min.
Time Frame
through study completion, an average of 1 year
Title
The positive and negative syndrome scale (PANSS)
Description
The Positive and Negative Syndrome Scale (PANSS) was developed out of the need for a well-operationalized method of assessing these syndromes in schizophrenia, including their relationship to one another and to global psychopathology
Time Frame
through study completion, an average of 1 year
Title
Adults Subjective Assessment of Participation
Description
participation questionnaire that examine the level of engagement in different occupations
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment
Exclusion Criteria:
score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Reshef, Dr
Phone
04-6494351
Email
AlonReshef1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ravit Sela-Haran, OT
Phone
050-3274443
Email
haranravit@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia
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