Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI (EF-VAPS)
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Lack of Physical Activity||Behavioral: Virtual Action Planning Supermarket (VAP-S) Software||Phase 1|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103453
|Contact: Gary Sinoff, MD, PhD||+972-4-8250552||GarySi@clalit.org.il|
|Cognitive Clinic, Carmel Medical Center||Recruiting|
|Haifa, Israel, 34362|
|Contact: Gary Sinoff, MD, PhD +972-4-8250552 GarySi@clalit.org.il|
|Principal Investigator: Gary Sinoff, MD, PhD|
|Principal Investigator:||Gary Sinoff, MD, PhD||Carmel Medical center, Haifa, Israel|