NCT02847923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

July 21, 2016

Last Update Submit

July 25, 2016

Conditions

Speech Impairment

Keywords

Mobile DevicesAugmentative and Alternative CommunicationCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Presentation of alternative communication applicationOther: Familiarization with the software interfaceOther: Test of the softwareOther: Answer the questionnaire

Interventions

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.

Group Experimental
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

Group Experimental
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.

Group Experimental
Answer the questionnaireOTHER

After performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use.

Group Experimental

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cerebral Palsy and speech disorder

You may not qualify if:

  • visual impairment and / or severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cid Torquato

Mogi das Cruzes, São Paulo, Brazil

Location

Sesi Suzano

Suzano, São Paulo, 08673-270, Brazil

Location

MeSH Terms

Conditions

Speech DisordersCerebral Palsy

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Flávio C Amate, Dr

    Núcleo de Pesquisas Tecnologicas - NPT/UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 28, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)