Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's

This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. The specific objective of this research was to develop and validate a virtual environment of games (called SorrisoTur) that allows the intervention of cognitive training.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: Virtual Environment

Detailed Description

SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which were coded in the form of 2D mini-games that are run on a computer connected to the Web, and designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual skills, language (expression, comprehension, reading, and writing) and personality/behavior. For the comparison of results, three groups were created; one group of elderly people with Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence Scale for Adults (WAIS-III) before and after of interventions with the games.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Mogi das Cruzes, São Paulo, Brazil, 08780-911
      • Terigi Augusto Scardovelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People with physical or psychological conditions allow interacting with digital games;
• Elderly over 60 years with mild Alzheimer;
• Seniors over 60 Healthy;
• Healthy Youth;

Exclusion Criteria:

• People without physical or psychological conditions allow interacting with digital games;
• Elderly people over 60 years old who have any type of dementia other than Alzheimer, or moderate or severe Alzheimer;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy elderly people; Twelve healthy elderly people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.	Other: Virtual Environment; The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.
Experimental: Elderly people with Alzheimer's in the initial phase; Seven elderly people with Alzheimer's in the initial phase. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.	Other: Virtual Environment; The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.
Experimental: Healthy young people; Fifteen healthy young people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.	Other: Virtual Environment; The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on Wechsler Intelligence Scale for Adults (WAIS-III)	The WAIS-III is an intellectual assessment that aims to analise the measures of the following Factorial Scales and Indexes: Verbal IQ (intelligence quotient), Execution IQ, Total IQ, Verbal Understanding Index, Perceptual Organization Indexes, Operational Memory Indexes and Processing speed index.	Baseline and after 4 weeks
Change on Mini Mental State Examination (MMSE)	The MMSE is a data collection instrument widely used in cases of dementia, it evaluates temporal and spatial orientation, short-term memory (immediate or attention) and skills of evocation, calculation, praxis, visuospatial, communication and language.	Baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: University of Mogi das Cruzes
• Investigators: Principal Investigator: Marcia A Bissaco, PhD, University of Mogi das Cruzes

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: CAAE: 54290416.9.0000.5497

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No