Software for Alternative Communication

Speech Impairment Clinical Trial

Official title:

Software for Alternative Communication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847923
• Other study ID #: 49324115.0.0000.5497
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: July 25, 2016
• Start date: October 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: University of Mogi das Cruzes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is evaluate a software developed for alternative communication designed for people with speech difficulties. The software was executed by 30 volunteers using mobile devices that helped to play the scenarios simulated of communication situations.

Description:

Communication is a fundamental element that contributes to the development of the human being, promoting their coexistence in society. However, several factors, among them the Cerebral palsy (CP), can cause changes in muscle tone, causing injury in phono-articulatory which prevent or impair the speech production. This research aims to the development of a mobile application to promote the augmentative and alternative communication for people with CP, which adapt to the characteristics of motor limitations of these users. A mobile application was developed with pictographic resources and a voice synthesis engine, which can be customized according to the level of motor impairment and need for communication of the user. Were recruited 30 volunteers with CP who have speech difficulties and motor impairment. By means of a test script, these volunteers have used the mobile application and evaluated their usability using the questionnaire System Usability Scale (SUS), which contains 10 questions related to the ease of learning, efficiency, ease of memorization, occurrence of runtime errors of execution and level of user satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Cerebral Palsy and speech disorder

Exclusion Criteria:

• visual impairment and / or severe cognitive impairment

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Speech Disorders
• Speech Impairment

Intervention

Other:
• Presentation of alternative communication application
At this stage the purpose of the application is submitted, what its purpose and its features in a brief and clear manner.
• Familiarization with the software interface
At this stage, the volunteer will be asked to use the application by himself for a short time so that he can get acquainted and learn to use it
• Test of the software
Then, the volunteer is instructed to use the application following a script task that will expose a simple and fast way all the application features. These tasks have easy actions to be executed, for example: The user must communicate through the application the phrase "I want to drink water," so that he will be instructed to perform the actions to select the option and then drink the water option.
• Answer the questionnaire
After performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use.

Locations

Country	Name	City	State
Brazil	Cid Torquato	Mogi das Cruzes	São Paulo
Brazil	Sesi Suzano	Suzano	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Mogi das Cruzes	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Federal de Educação, Ciência e Tecnologia de São Paulo - IFSP

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	Questionnaire based in System Usability Scale (SUS) with 10 item questionnaire and five response options for respondents. Each response can be chosen in range: totally disagree, disagree, neither agree nor disagree, agree and totally agree.	15 minutes	Yes