Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI (EF-VAPS)
Change in Executive Functions and in Instrumental Activities of Daily Living as a Result of Intervention by Virtual Supermarket Environment Among People With Mild Cognitive Impairment.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Scientific and clinical research in the area of Alzheimer's disease (AD) during the last years have shifted their focus to earlier diagnosis and especially to the transitional phase between normal aging and dementia, named Mild Cognitive Impairment (MCI).Lately, the concept of MCI has been expanded to address observed clinical heterogeneity, and subtypes were recognized: amnestic (including memory impairment) and non-amnestic (including impairment in other non-memory cognitive domains), with the later including deficits in executive functioning Executive functions (EF) are defined as higher order functions that are needed for completing complex or non-routine tasks. Deficits in EF refer to a collection of deficits in attention, planning, problem-solving, multitasking, monitoring and behavioral control and persons who suffer from impairments in EF typically have difficulty in initiating or suspending activities, show impaired mental flexibility, as well as increased distractibility and have difficulty in learning novel tasks despite apparently intact cognitive abilities.
Lately, an increasing amount of studies suggest that persons with MCI might have deficits in EF, moreover, persons presenting a combination of executive deficits and memory deficits were found to be a high risk group for conversion to AD.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Haifa, Israel, 34362
- Rekrytering
- Cognitive Clinic, Carmel Medical Center
-
Kontakt:
- Gary Sinoff, MD, PhD
- Telefonnummer: +972-4-8250552
- E-post: GarySi@clalit.org.il
-
Huvudutredare:
- Gary Sinoff, MD, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age 60+
- Diagnosed as suffering from MCI
- No impaired judgement
- Verbal and written proficiency in Hebrew
- Normal or corrected-to-normal vision and hearing ability
- Independent in ADL function
- Lives in the community
- Able to perform task of shopping.
Exclusion Criteria:
- Suffering from other coexistent neurological diseases (e.g. stroke, muscular dystrophy)
- Has acute arthritis
- Poorly controlled hypothyroidism
- Suffering from physical or sensory limitations, as by self-report or noted by the investigator, that may limit the use of a computer's mouse
- No skills in performing shopping task
- Defined as suffering from depression as determined by the rating scale for depression
- Diagnosed as suffering from dementia as defined by Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention Group
Study group are persons diagnosed as suffering from Mild Cognitive Impairment will undergo a series of 9 sessions on a computer program of a virtual supermarket to improve their Executive and IADL functions.
|
The VAP-S simulates a supermarket with multiple aisles displaying items. Several obstacles are designed to hinder the progression of the shopper along the aisles. In addition, virtual humans populate the supermarket. The VAP-S is designed so that the user enters the supermarket behind the cart and navigates within the supermarket via the keyboard keys. He is thus able to experience the environment personally without any intermediate. The task is to purchase 7 items from a list, proceed to the cashier and pay for them. We propose 9 sessions of 45 minutes. The results will be analyzed to develop goals for intervention, together with the client to study his awareness of his performance of IADL and Executive functions and to enhance his motivation to participate in the intervention.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.
Tidsram: 1 month after intervention
|
The NexAde® is a computerized assessment test for deficits in cognition and executive function.
The test consists of several neuropsychological tests used in clinical practice and research and the domains being assessed are attention, memory, visuomotor learning, spatial memory, executive function and mental flexibility.
The test has been adapted for older adults who are not familiar with computers and was found to be reliable and valid.
|
1 month after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improved performance in IADL, both generally and especially in shopping task.
Tidsram: 1 month after intervention
|
IADL will be examined by means of results on the MET (Multiple Errands Test) and Lawton and Brody's IADL instruments.
The MET assesses executive function while performing an everyday activity by observation.
It consists of three main tasks in shopping: purchase six items, find out four different pieces of information and meet the examiner at a specific time at a predetermined location.
Lawton & Brawdy's IADL instrument evaluates the subject's capacity to perform eight different IADL tasks such as cooking, the use of transportation and shopping.
|
1 month after intervention
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gary Sinoff, MD, PhD, Carmel Medical Center, Haifa, Israel
Publikationer och användbara länkar
Allmänna publikationer
- Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. doi: 10.1017/S104161020700631X. Epub 2007 Oct 25.
- Sgaramella TM, Borgo F, Mondini S, Pasini M, Toso V, Semenza C. Executive deficits appearing in the initial stage of Alzheimer's disease. Brain Cogn. 2001 Jun-Jul;46(1-2):264-8. doi: 10.1016/s0278-2626(01)80080-4.
- Josman N, Schenirderman AE, Klinger E, Shevil E. Using virtual reality to evaluate executive functioning among persons with schizophrenia: a validity study. Schizophr Res. 2009 Dec;115(2-3):270-7. doi: 10.1016/j.schres.2009.09.015. Epub 2009 Oct 22.
- Werner P, Rabinowitz S, Klinger E, Korczyn AD, Josman N. Use of the virtual action planning supermarket for the diagnosis of mild cognitive impairment: a preliminary study. Dement Geriatr Cogn Disord. 2009;27(4):301-9. doi: 10.1159/000204915. Epub 2009 Mar 2.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CMC090105CTIL
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .