- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03146364
Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia
Evaluation of Executive Function With Static and Dynamic Shopping Assignment in Virtual Reality Among People With Schizophrenia
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Alon Reshef, Dr
- Telefonnummer: 04-6494351
- E-post: AlonReshef1@gmail.com
Studer Kontakt Backup
- Navn: Ravit Sela-Haran, OT
- Telefonnummer: 050-3274443
- E-post: haranravit@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Hospitalization patients
patients in psychiatric hospitalization will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)
|
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
Andre navn:
|
Eksperimentell: Ambulatory patients
patients being treated in a clinic will take part in tests at Virtual Reality - Virtual Interactive Supermarket environment (diagnosis)
|
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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Modified 4 item test
Tidsramme: through study completion, an average of 1 year
|
"buy" 4 items with budget constraints, using the VIS
|
through study completion, an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Revised Observed Tasks of Daily Living (OTDL-R)
Tidsramme: through study completion, an average of 1 year
|
evaluation of IADL using various tasks include problem solving
|
through study completion, an average of 1 year
|
Executive Function Performance Test (EFPT)
Tidsramme: through study completion, an average of 1 year
|
executive function assessment using 5 different tasks
|
through study completion, an average of 1 year
|
Trail Making Test A & B (TMT)
Tidsramme: 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.
|
through study completion, an average of 1 year
|
The positive and negative syndrome scale (PANSS)
Tidsramme: 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
|
through study completion, an average of 1 year
|
Adults Subjective Assessment of Participation
Tidsramme: through study completion, an average of 1 year
|
participation questionnaire that examine the level of engagement in different occupations
|
through study completion, an average of 1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HaEmekAlon
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