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NCT03033797 Clinical Trial

Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities

Intellectual Disability Clinical Trial

Official title:
Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03033797
Other study ID # 54172416.6.0000.0082
Secondary ID
Status Recruiting
Phase N/A
First received January 20, 2017
Last updated August 14, 2017
Start date March 8, 2016
Est. completion date March 24, 2018

Study information
Verified date August 2017
Source Faculdade de Medicina do ABC
Contact Regiani Guarnieri
Phone 4899344597
Email regianig1@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 165
Est. completion date March 24, 2018
Est. primary completion date March 10, 2018
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility Inclusion Criteria:

- All the children that uses to go the institution where the data collection will be realised (APAE).

Exclusion Criteria:

- Those who decline to participate

- Those who are not present in the two days of evaluation.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MoviLetrando
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
• MoveHero
Half of the participants will play 2 minutes of the game MoveHero.

Locations
Country Name City State
Brazil Associação de Pais e Amigos dos Excepcionais São 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 total reaction time decrease in time indicates a better performance 6 minutes
Secondary time MoviLetrando less time to hit the targets indicates a better performance up to 15 days
Secondary acerts MoviLetrando more hits indicates a better performance up to 15 days
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