Software for Alternative Communication
Primary Purpose
Speech Impairment
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Presentation of alternative communication application
Familiarization with the software interface
Test of the software
Answer the questionnaire
Sponsored by
About this trial
This is an interventional health services research trial for Speech Impairment focused on measuring Mobile Devices, Augmentative and Alternative Communication, Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Cerebral Palsy and speech disorder
Exclusion Criteria:
- visual impairment and / or severe cognitive impairment
Sites / Locations
- Cid Torquato
- Sesi Suzano
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group Experimental
Arm Description
All the volunteers will use the software and then answer the questionnaire. They will be familiar with the software interface, performs an initial test to learn how to use the software, run a test script and answer the questionnaire.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02847923
First Posted
July 21, 2016
Last Updated
July 25, 2016
Sponsor
University of Mogi das Cruzes
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Federal de Educação, Ciência e Tecnologia de São Paulo - IFSP
1. Study Identification
Unique Protocol Identification Number
NCT02847923
Brief Title
Software for Alternative Communication
Official Title
Software for Alternative Communication
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mogi das Cruzes
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Federal de Educação, Ciência e Tecnologia de São Paulo - IFSP
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Impairment
Keywords
Mobile Devices, Augmentative and Alternative Communication, Cerebral Palsy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Experimental
Arm Type
Experimental
Arm Description
All the volunteers will use the software and then answer the questionnaire. They will be familiar with the software interface, performs an initial test to learn how to use the software, run a test script and answer the questionnaire.
Intervention Type
Other
Intervention Name(s)
Presentation of alternative communication application
Intervention Description
At this stage the purpose of the application is submitted, what its purpose and its features in a brief and clear manner.
Intervention Type
Other
Intervention Name(s)
Familiarization with the software interface
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Test of the software
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Answer the questionnaire
Intervention Description
After performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use.
Primary Outcome Measure Information:
Title
Questionnaire
Description
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.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cerebral Palsy and speech disorder
Exclusion Criteria:
visual impairment and / or severe cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flávio C Amate, Dr
Organizational Affiliation
Núcleo de Pesquisas Tecnologicas - NPT/UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cid Torquato
City
Mogi das Cruzes
State/Province
São Paulo
Country
Brazil
Facility Name
Sesi Suzano
City
Suzano
State/Province
São Paulo
ZIP/Postal Code
08673-270
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Software for Alternative Communication
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