Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

NCT ID: NCT03146364

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-08-01

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hospitalization patients

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

Group Type: EXPERIMENTAL

Virtual Reality - Virtual Interactive Supermarket

Intervention Type: DEVICE

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

Ambulatory patients

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

Group Type: EXPERIMENTAL

Virtual Reality - Virtual Interactive Supermarket

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

SeeMe

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Alon Reshef

Head of psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Alon Reshef, Dr

Role: CONTACT

AlonReshef1@gmail.com

04-6494351

Ravit Sela-Haran, OT

Role: CONTACT

haranravit@gmail.com

050-3274443

Other Identifiers

HaEmekAlon

Identifier Type: -

Identifier Source: org_study_id