Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Unknown status
CT.gov ID
NCT03146364
Collaborator
(none)
40
2
13

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality - Virtual Interactive Supermarket
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia
Anticipated Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hospitalization patients

patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

Device: Virtual Reality - Virtual Interactive Supermarket
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
Other Names:
  • SeeMe
  • Experimental: Ambulatory patients

    patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)

    Device: Virtual Reality - Virtual Interactive Supermarket
    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
    Other Names:
  • SeeMe
  • Outcome Measures

    Primary Outcome Measures

    1. Modified 4 item test [through study completion, an average of 1 year]

      "buy" 4 items with budget constraints, using the VIS

    Secondary Outcome Measures

    1. Revised Observed Tasks of Daily Living (OTDL-R) [through study completion, an average of 1 year]

      evaluation of IADL using various tasks include problem solving

    2. Executive Function Performance Test (EFPT) [through study completion, an average of 1 year]

      executive function assessment using 5 different tasks

    3. Trail Making Test A & B (TMT) [through study completion, an average of 1 year]

      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.

    4. The positive and negative syndrome scale (PANSS) [through study completion, an average of 1 year]

      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

    5. Adults Subjective Assessment of Participation [through study completion, an average of 1 year]

      participation questionnaire that examine the level of engagement in different occupations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alon Reshef, Head of psychiatry, HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT03146364
    Other Study ID Numbers:
    • HaEmekAlon
    First Posted:
    May 9, 2017
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    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
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alon Reshef, Head of psychiatry, HaEmek Medical Center, Israel
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 9, 2017