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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02798081
Other study ID # 52305215.3.0000.0082
Secondary ID
Status Completed
Phase N/A
First received May 31, 2016
Last updated February 6, 2018
Start date August 2016
Est. completion date December 2017

Study information

Verified date February 2018
Source Faculdade de Medicina do ABC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for beginners will participate in the study. The evaluation will consist mainly in answering two validated questionnaires on socialization, the short Social and Emotional Loneliness Scale for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and performance will also be measured by three virtual reality games, namely Reaction Time, Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes which includes 15 minutes for practicing virtual reality games.


Description:

Background: The use of new Technologies, such as the resources of augmentative and alternative communication (AAC), appears as a valuable tool to promote socialization in many groups of people. Serious games with virtual reality are an example of these resources and might bring benefits also to the elderly population, allowing an enjoyable and safe interaction that uses various sensorial stimuli. The purpose of this study protocol is to evaluate the effects of practicing virtual reality games on elderly socialization.

Method/Design: It will be an experimental, prospective longitudinal study which will use serious games with virtual reality to improve the socialization of elderly people. A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for beginners will participate in the study. The evaluation will consist mainly in answering two validated questionnaires on socialization, the short Social and Emotional Loneliness Scale for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and performance will also be measured by three virtual reality games, namely Reaction Time, Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes which includes 15 minutes for practicing virtual reality games.

Discussion: This study will determine whether the practice of virtual reality games in addition to the usual informatics classes contributes to elderly socialization. The evolution in socialization, the evolution of reaction time and performance in virtual reality games and the correlation of motor learning to socialization will also be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- people aged over 60 years;

- both sexes

- spontaneously enrolled in the informatics beginner class for seniors of the Center of Reference for Elderly (CRI) in Ribeirão Pires

Exclusion Criteria:

- Less than 75% of frequency in the classes between the assessments;

- do not completion of the three moments of assessment;

- having motor impairment of the upper limbs or cognition impairment,which prevents them to practice the games.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Single arm study
In Step 1 the elderly will participate of eight conventional computer classes which they were spontaneously enrolled. In Step 2, 10 minutes of the next eight classes will be used to practice serious games using virtual reality, using physical interface (keyboard or mouse).

Locations

Country Name City State
Brazil Faculdade de Medicina do ABC Santo André Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Socialization assessed by SELSA-S Improvement on self-perceived loneliness, representing the socialization level of the elderly, comparing baseline to the first 8 usual computer classes and after the 8 classes with virtual reality games. This will be verified through a decrease in the score of SELSA-S.
SELSA-S has 15 items, scoring up to 7 in each, 105 in total.
up to 10 weeks
Secondary time of response during the practise of virtual reality games as assessed by TRT, Random and Moviletrando It's expected to have a decrease in time of response during the practise of virtual reality games. It will be recorded by the softwares of the games: Time response (TRT), Random and Moviletrando up to 10 weeks
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