- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847923
Software for Alternative Communication
July 25, 2016 updated by: Flavio Cezar Amate, University of Mogi das Cruzes
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
30
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
-
-
São Paulo
-
Mogi das Cruzes, São Paulo, Brazil
- Cid Torquato
-
Suzano, São Paulo, Brazil, 08673-270
- Sesi Suzano
-
-
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
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cerebral Palsy and speech disorder
Exclusion Criteria:
- visual impairment and / or severe cognitive impairment
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: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 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.
|
At this stage the purpose of the application is submitted, what its purpose and its features in a brief and clear manner.
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
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.
After performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Flávio C Amate, Dr, Núcleo de Pesquisas Tecnologicas - NPT/UMC
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
October 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 21, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimate)
July 28, 2016
Study Record Updates
Last Update Posted (Estimate)
July 28, 2016
Last Update Submitted That Met QC Criteria
July 25, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49324115.0.0000.5497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Speech Impairment
-
McGill UniversityUnknownDyslexia | Developmental Articulation Disorder | Speech Articulation Disorder | Phonological ImpairmentCanada
-
NHS Health Technology Assessment ProgrammeCompletedSpeech or Language Impairment Following StrokeUnited Kingdom
-
University of WyomingCompletedSpeech Disorders | Speech Sound Disorder | Speech Delay | Phonology Disorder | Phonology Impairment | Phonological Disorder | Articulation Disorders in Children | Developmental Phonological Disorder | Articulation Disorders, DevelopmentalUnited States
-
Sohag UniversityRecruitingApraxia of SpeechEgypt
-
University Hospital, GhentCompletedAphasia, Acquired | Short-Term Memory ImpairmentBelgium
-
Charité Neurocure AG FlöelUnknownAphasia | Anomia (Word-Finding Impairment)Germany
-
Institut PasteurInstitut de l'AuditionNot yet recruiting
-
Medical College of WisconsinRecruiting
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)Not yet recruiting
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed
Clinical Trials on Presentation of alternative communication application
-
ThinkWellCompletedBehavior, Adaptive | Decision AnalysisUnited Kingdom
-
Riphah International UniversityCompleted
-
Children's Hospital Medical Center, CincinnatiChildren's Hospital ColoradoRecruitingHearing Loss | Social Behavior | Language DevelopmentUnited States
-
Iowa Adaptive Technologies, Inc.National Institute of Nursing Research (NINR)CompletedProblems With Access to Health Care
-
Oregon Health and Science UniversityFlorida State UniversityRecruitingIntellectual Disability | Speech and Language DisorderUnited States
-
University Health Network, TorontoNot yet recruitingSolid Organ Transplant | Liver Transplant | Kidney Transplant | Heart Transplant
-
Oslo University HospitalCompleted
-
St. Joseph's Healthcare HamiltonMcMaster UniversityUnknownChronic Kidney DiseaseCanada
-
Ottawa Hospital Research InstituteCompletedElective Surgical ProceduresCanada
-
University of VirginiaNational Institute of Mental Health (NIMH)WithdrawnPost-Traumatic Stress DisorderUnited States