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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04919005
Other study ID # CAAE: 54290416.9.0000.5497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date July 20, 2017

Study information

Verified date June 2021
Source University of Mogi das Cruzes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 20, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Terigi Augusto Scardovelli Mogi das Cruzes São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Mogi das Cruzes

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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