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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
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring Virtual Reality

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 1, 2017
    Last Updated
    May 6, 2017
    Sponsor
    HaEmek Medical Center, Israel
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    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

    Learn more about this trial

    Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

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