Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual Environment
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease
Eligibility Criteria
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;
Sites / Locations
- Terigi Augusto Scardovelli
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy elderly people
Elderly people with Alzheimer's in the initial phase
Healthy young people
Arm Description
Twelve healthy elderly people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.
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.
Fifteen healthy young people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04919005
First Posted
June 2, 2021
Last Updated
June 2, 2021
Sponsor
University of Mogi das Cruzes
1. Study Identification
Unique Protocol Identification Number
NCT04919005
Brief Title
Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Official Title
Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mogi das Cruzes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy elderly people
Arm Type
Experimental
Arm Description
Twelve healthy elderly people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.
Arm Title
Elderly people with Alzheimer's in the initial phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy young people
Arm Type
Experimental
Arm Description
Fifteen healthy young people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test.
Intervention Type
Other
Intervention Name(s)
Virtual Environment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on Wechsler Intelligence Scale for Adults (WAIS-III)
Description
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.
Time Frame
Baseline and after 4 weeks
Title
Change on Mini Mental State Examination (MMSE)
Description
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.
Time Frame
Baseline and after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia A Bissaco, PhD
Organizational Affiliation
University of Mogi das Cruzes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Terigi Augusto Scardovelli
City
Mogi das Cruzes
State/Province
São Paulo
ZIP/Postal Code
08780-911
Country
Brazil
12. IPD Sharing Statement
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Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
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