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Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI (EF-VAPS)

20. juli 2011 opdateret af: Carmel Medical Center

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.

The aim of the study is to investigate the feasibility of using a virtual supermarket as an intervention tool for overcoming deficits in executive function as well as enhancing IADL performance among persons with Mild Cognitive Impairment. The working hypotheses are that there will be improvement in executive functions, and the improvement in the executive functions will result in better performance in Instrumental Activities of Daily Living, both generally and especially in shopping task

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Haifa, Israel, 34362
        • Rekruttering
        • Cognitive Clinic, Carmel Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Gary Sinoff, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Virtual Action Planning Supermarket (VAP-S) Software

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.

Andre navne:
  • VAP-S Virtual Action Planning - Supermarket
  • Virtools Development - Interactive 3D Development Tool
  • Discreet 3D Studio Max4 Graphics

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improved performance in IADL, both generally and especially in shopping task.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Carmel Medical Center

Efterforskere

  • Ledende efterforsker: Gary Sinoff, MD, PhD, Carmel Medical Center, Haifa, Israel

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Forventet)

1. november 2011

Studieafslutning (Forventet)

1. maj 2012

Datoer for studieregistrering

Først indsendt

7. april 2010

Først indsendt, der opfyldte QC-kriterier

13. april 2010

Først opslået (Skøn)

14. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CMC090105CTIL

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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