Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI

NCT01103453 | Unknown Phase 1 DMC

• 1 other identifier: CMC090105CTIL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Cognitive Impairment; Lack of Physical Activity

Keywords

MCI; Executive Function; ADL; Virtual Supermarket

Outcome Measures

Primary Outcomes (1)

• Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.

  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

Secondary Outcomes (1)

• Improved performance in IADL, both generally and especially in shopping task.

  1 month after intervention

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Virtual Action Planning Supermarket (VAP-S) Software BEHAVIORAL

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.

Also known as: VAP-S Virtual Action Planning - Supermarket, Virtools Development - Interactive 3D Development Tool, Discreet 3D Studio Max4 Graphics

Intervention Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Cognitive Clinic, Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Related Publications (4)

• 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.

  PMID: 17958927 BACKGROUND

• 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.

  PMID: 11527345 BACKGROUND

• 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.

  PMID: 19850451 BACKGROUND

• 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.

  PMID: 19252401 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Gary Sinoff, MD, PhD

  Carmel Medical center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Sinoff, MD, PhD

CONTACT

+972-4-8250552; GarySi@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 14, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

IL (1)