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

Sponsor

University of Mogi das Cruzes (Other)

Overall Status

Completed

CT.gov ID

NCT04919005

Collaborator

(none)

Enrollment

Location

Arms

12.6

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Other: Virtual Environment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Apr 30, 2017

Actual Study Completion Date :

Jul 20, 2017

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

Change on Wechsler Intelligence Scale for Adults (WAIS-III) [Baseline and after 4 weeks]
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.
Change on Mini Mental State Examination (MMSE) [Baseline and after 4 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Terigi Augusto Scardovelli	Mogi das Cruzes	São Paulo	Brazil	08780-911

Sponsors and Collaborators

University of Mogi das Cruzes

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Terigi Augusto Scardovelli, Associate Professor, University of Mogi das Cruzes

ClinicalTrials.gov Identifier:

NCT04919005

Other Study ID Numbers:

CAAE: 54290416.9.0000.5497

First Posted:

Jun 9, 2021

Last Update Posted:

Jun 9, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Jun 9, 2021