- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02798081
Virtual Reality Games for Elderly Socialization
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Sao Paulo
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Santo André, Sao Paulo, Brazil, 09060-650
- Faculdade de Medicina do ABC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm study
A minimum of 46 elderly, students of a informatics course, will participate in the study.
Initially, the students will have 8 usual informatics classes in the institution where they were enrolled spontaneously.
Then, during the next 8 classes (from class 9 to class 16) they will practice 10 minutes of virtual reality games, as part of the class.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socialization assessed by SELSA-S
Time Frame: up to 10 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time of response during the practise of virtual reality games as assessed by TRT, Random and Moviletrando
Time Frame: up to 10 weeks
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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
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up to 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thaiany Antunes, Master, Faculdade de Medicina do ABC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 52305215.3.0000.0082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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