Intellectual DisabilityNCT03033797
Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
A study testing MoviLetrando and MoveHero in people with Intellectual Disability, run by Faculdade de Medicina do ABC at 1 site in Brazil.
Trial summary
Background: Games using motion capture from webcam have become increasingly popular. A population that lacks much stimulus in the teaching-learning process has under-explored the benefits of this kind of games: The Intellectually Disabled. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- MoviLetrando and MoveHero
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Mar 2016to 24 Mar 2018
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All the children that uses to go the institution where the data collection will be realised (APAE).
Who cannot join
- Those who decline to participate
- Those who are not present in the two days of evaluation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Associação de Pais e Amigos dos Excepcionais
São Paulo, 04040-033
Viviane AM Perico, +551150807009 ext. 345, vivianeperico@apaesp.org.br
About this study
Background: Games using motion capture from webcam have become increasingly popular. A population that lacks much stimulus in the teaching-learning process has under-explored the benefits of this kind of games: The Intellectually Disabled. The aim of this study is to analyse the effectiveness of games with virtual reality in the total reaction time. Method: A convenience sample of 165 Intellectually Disabled participants will have their performance measured using a virtual reality game. The intervention is to play two different games twice, in two sessions with an interval of, at least, seven days between the sessions. Participants will be randomized between two raters, both master students.
- Conditions
- Intellectual Disability
- Being tested
- MoviLetrando, MoveHero
- Keywords
- assitive technology, virtual reality games, intellectual disability, augmentative and alternative communication
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoviLetrandoDevice
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
MoveHeroDevice
Half of the participants will play 2 minutes of the game MoveHero.
| Study group | Role | What they receive |
|---|---|---|
| MoviLetrando-MoveHero | Experimental | Half of the children will play first two different levels of the game MoviLetrando (2 minutes each) and, after the game MoveHero, more 2 minutes Receives: Device: MoviLetrando; Device: MoveHero |
| MoveHero-MoviLetrando | Experimental | The other half of the children will play first 2 minutes of the game MoveHero and after, two different levels of the Game MoviLetrando, two minutes each. Receives: Device: MoviLetrando; Device: MoveHero |
What is being measured
The primary outcome is the main question the study is designed to answer.
total reaction time
decrease in time indicates a better performance
Measured: 6 minutes
Secondary outcomes (2)
time MoviLetrando
less time to hit the targets indicates a better performance
Measured: up to 15 days
acerts MoviLetrando
more hits indicates a better performance
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start8 Mar 2016
- Primary completion10 Mar 2018 (estimated)
- Study completion24 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina do ABC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regiani Guarnieri, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033797
- Sponsor's protocol ID
- 54172416.6.0000.0082
- Status last verified
- Aug 2017
- First submitted
- 20 Jan 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT03033797
- Acronym / sponsor ID
- 54172416.6.0000.0082
- Conditions
- Intellectual Disability
- Keywords
- assitive technology, virtual reality games, intellectual disability, augmentative and alternative communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Faculdade de Medicina do ABCUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 10 Mar 2018 (estimated)
- Study completion
- 24 Mar 2018 (estimated)
- First posted
- 27 Jan 2017 (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.
Background: Games using motion capture from webcam have become increasingly popular. A population that lacks much stimulus in the teaching-learning process has under-explored the benefits of this kind of games: The Intellectually Disabled. The aim of this study is to analyse the effectiveness of games with virtual reality in the total reaction time. Method: A convenience sample of 165 Intellectually Disabled participants will have their performance measured using a virtual reality game. The intervention is to play two different games twice, in two sessions with an interval of, at least, seven days between the sessions. Participants will be randomized between two raters, both master students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoviLetrando-MoveHero | Experimental | Device: MoviLetrando, Device: MoveHeroHalf of the children will play first two different levels of the game MoviLetrando (2 minutes each) and, after the game MoveHero, more 2 minutes |
| MoveHero-MoviLetrando | Experimental | Device: MoviLetrando, Device: MoveHeroThe other half of the children will play first 2 minutes of the game MoveHero and after, two different levels of the Game MoviLetrando, two minutes each. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All the children that uses to go the institution where the data collection will be realised (APAE).
Key exclusion criteria (2 listed)
- Those who decline to participate
- Those who are not present in the two days of evaluation.
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 |
|---|---|---|
| MoviLetrandoHalf of the participants will play two different levels of the Game MoviLetrando, two minutes each. | Device | MoveHero-MoviLetrando, MoviLetrando-MoveHero |
| MoveHeroHalf of the participants will play 2 minutes of the game MoveHero. | Device | MoveHero-MoviLetrando, MoviLetrando-MoveHero |
Primary outcome
total reaction time
Time frame: 6 minutes
decrease in time indicates a better performance
2 secondary outcomes
time MoviLetrando
Time frame: up to 15 days
acerts MoviLetrando
Time frame: up to 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoviLetrando and MoveHero in people with Intellectual Disability, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regiani Guarnieri (4899344597, regianig1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total reaction time (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.