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

August 14, 2017 updated by: Regiani Guarnieri, Faculdade de Medicina do ABC
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04040-033
        • Recruiting
        • Associação de Pais e Amigos dos Excepcionais
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MoviLetrando-MoveHero
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
Device: MoviLetrando
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
Device: MoveHero
Half of the participants will play 2 minutes of the game MoveHero.
Experimental: MoveHero-MoviLetrando
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.
Device: MoviLetrando
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
Device: MoveHero
Half of the participants will play 2 minutes of the game MoveHero.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total reaction time
Time Frame: 6 minutes
decrease in time indicates a better performance
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time MoviLetrando
Time Frame: up to 15 days
less time to hit the targets indicates a better performance
up to 15 days
acerts MoviLetrando
Time Frame: up to 15 days
more hits indicates a better performance
up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Medicina do ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2016

Primary Completion (Anticipated)

March 10, 2018

Study Completion (Anticipated)

March 24, 2018

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54172416.6.0000.0082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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