- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
|
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Sperimentale: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Modified 4 item test
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Revised Observed Tasks of Daily Living (OTDL-R)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
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Adults Subjective Assessment of Participation
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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