AgedNCT02798081
Virtual Reality Games for Elderly Socialization
A study testing Single arm study in people with Aged, run by Faculdade de Medicina do ABC at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Single arm study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aged
- Being tested
- Single arm study
- Keywords
- augmentative and alternative communication, social inclusion, serious games, Information and communication technologies
- Medical subject headings
- Social Inclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single arm studyBehavioural
Also called practicing virtual reality games
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | 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. Receives: Behavioral: Single arm study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 weeks
Secondary outcomes (1)
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
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thaiany Pedrozo Campos Antunes, Faculdade de Medicina do ABC
- Investigators
- Thaiany Antunes, Master, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798081
- Sponsor's protocol ID
- 52305215.3.0000.0082
- Status last verified
- Feb 2018
- First submitted
- 31 May 2016
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Antunes TPC, Oliveira ASB, Crocetta TB, Antao JYFL, Barbosa RTA, Guarnieri R, Massetti T, Monteiro CBM, Abreu LC. Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design. Medicine (Baltimore). 2017 Mar;96(10):e5954. doi: 10.1097/MD.0000000000005954.
PubMed 28272198
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Games for Elderly Socialization
- ClinicalTrials.gov ID
- NCT02798081
- Acronym / sponsor ID
- 52305215.3.0000.0082
- Conditions
- Aged
- Keywords
- augmentative and alternative communication, social inclusion, serious games, Information and communication technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Behavioral: Single arm studyA 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single arm studyAlso: practicing virtual reality gamesIn 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). | Behavioural | Single arm study |
Primary outcome
Socialization assessed by SELSA-S
Time frame: up to 10 weeks
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.
1 secondary outcome
time of response during the practise of virtual reality games as assessed by TRT, Random and Moviletrando
Time frame: up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 28272198Antunes TPC, Oliveira ASB, Crocetta TB, Antao JYFL, Barbosa RTA, Guarnieri R, Massetti T, Monteiro CBM, Abreu LC. Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design. Medicine (Baltimore). 2017 Mar;96(10):e5954. doi: 10.1097/MD.0000000000005954.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thaiany Antunes, Master principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single arm study in people with Aged, run by Faculdade de Medicina do ABC at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socialization assessed by SELSA-S (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.