Speech ImpairmentNCT02847923
Software for Alternative Communication
A study testing Presentation of alternative communication application, Familiarization with the software interface and Test of the software in people with Speech Impairment, run by University of Mogi das Cruzes at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Speech Impairment
- What is being tested?
- Presentation of alternative communication application, Familiarization with the software interface and Test of the software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2015to Nov 2015
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cerebral Palsy and speech disorder
Who cannot join
- visual impairment and / or severe cognitive impairment
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Cid Torquato
Mogi das Cruzes, São Paulo
Sesi Suzano
Suzano, São Paulo, 08673-270
About this study
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.
Read the 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.
- Conditions
- Speech Impairment
- Being tested
- Presentation of alternative communication application, Familiarization with the software interface, Test of the software, Answer the questionnaire
- Keywords
- Mobile Devices, Augmentative and Alternative Communication, Cerebral Palsy
- Medical subject headings
- Speech Disorders, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presentation of alternative communication applicationOther
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 interfaceOther
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 softwareOther
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 questionnaireOther
After performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use.
| Study group | Role | What they receive |
|---|---|---|
| Group Experimental | Experimental | 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. Receives: Other: Presentation of alternative communication application; Other: Familiarization with the software interface; Other: Test of the software; Other: Answer the questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech ImpairmentStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Federal de Educação, Ciência e Tecnologia de São Paulo - IFSP
- Responsible party
- Principal investigator, Flavio Cezar Amate, University of Mogi das Cruzes
- Investigators
- Flávio C Amate, Dr, Principal investigator, Núcleo de Pesquisas Tecnologicas - NPT/UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847923
- Sponsor's protocol ID
- 49324115.0.0000.5497
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Software for Alternative Communication
- ClinicalTrials.gov ID
- NCT02847923
- Acronym / sponsor ID
- 49324115.0.0000.5497
- Conditions
- Speech Impairment
- Keywords
- Mobile Devices, Augmentative and Alternative Communication, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Federal de Educação, Ciência e Tecnologia de São Paulo - IFSP
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Jul 2016 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Experimental | Experimental | Other: Presentation of alternative communication application, Other: Familiarization with the software interface, Other: Test of the software, Other: Answer the questionnaireAll 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cerebral Palsy and speech disorder
Key exclusion criteria (1 listed)
- visual impairment and / or severe cognitive impairment
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 |
|---|---|---|
| Presentation of alternative communication applicationAt this stage the purpose of the application is submitted, what its purpose and its features in a brief and clear manner. | Other | Group Experimental |
| Familiarization with the software interfaceAt 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 | Other | Group Experimental |
| Test of the softwareThen, 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. | Other | Group Experimental |
| Answer the questionnaireAfter performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use. | Other | Group Experimental |
Primary outcome
Questionnaire
Time frame: 15 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Speech Impairment
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Voiceitt for People With Impairments in Speech
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Feasibility of Web-based Therapy Sessions
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The Signature of Alzheimer's Disease in Subjective Cognitive Decline
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A Developmental Framework For Linking Phonological And Morpho-syntactic Sequential Pattern Rules In DLD: Production
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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.
Flávio C Amate, Dr principal investigator
Núcleo de Pesquisas Tecnologicas - NPT/UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presentation of alternative communication application, Familiarization with the software interface and Test of the software in people with Speech Impairment, run by University of Mogi das Cruzes at 2 sites 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 1 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: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 15 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 28 Jul 2016; AzTrials last refreshed its copy on 27 Oct 2026.