Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03146364
• Other study ID #: HaEmekAlon
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2017
• Last updated: May 6, 2017
• Start date: July 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: May 2017
• Source: HaEmek Medical Center, Israel
• Contact: Alon Reshef, Dr
• Phone: 04-6494351
• Email: AlonReshef1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified 4 item test	"buy" 4 items with budget constraints, using the VIS	through study completion, an average of 1 year
Secondary	Revised Observed Tasks of Daily Living (OTDL-R)	evaluation of IADL using various tasks include problem solving	through study completion, an average of 1 year
Secondary	Executive Function Performance Test (EFPT)	executive function assessment using 5 different tasks	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	Adults Subjective Assessment of Participation	participation questionnaire that examine the level of engagement in different occupations	through study completion, an average of 1 year