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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103453
Recruitment Status : Unknown
Verified July 2011 by Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : April 14, 2010
Last Update Posted : July 21, 2011
Information provided by:
Carmel Medical Center

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Lack of Physical Activity Behavioral: Virtual Action Planning Supermarket (VAP-S) Software Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

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

Primary Outcome Measures :
  1. Improvement in executive functions by means of comparison to the results on the NexAde® computerized test. [ Time Frame: 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.

Secondary Outcome Measures :
  1. Improved performance in IADL, both generally and especially in shopping task. [ Time Frame: 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.

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103453

Contact: Gary Sinoff, MD, PhD +972-4-8250552

Cognitive Clinic, Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Gary Sinoff, MD, PhD    +972-4-8250552   
Principal Investigator: Gary Sinoff, MD, PhD         
Sponsors and Collaborators
Carmel Medical Center
Principal Investigator: Gary Sinoff, MD, PhD Carmel Medical center, Haifa, Israel

Responsible Party: Dr Gary Sinoff, Director Cognitive Clinic, Carmel Medical Center, Haifa, Israel Identifier: NCT01103453     History of Changes
Other Study ID Numbers: CMC090105CTIL
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Carmel Medical Center:
Executive Function
Virtual Supermarket

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms