Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2019-06-05
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Assessment
A comprehensive AAC assessment collecting clinical and personal data required to select a speech-generating device (SGD) is conducted along with a trial of three AAC technology solutions, followed by a trial for BCI access to an AAC system.
Speech generating device (SGD) evaluation including BCI access
At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.
Training and Treatment
AAC training and treatment services will be provided and communication performance outcomes monitored over the course of studying clinical treatment services. At monthly home visits the SLP gathers clinical and personal data on communication performance outcomes and user satisfaction of their AAC system and any alternative access methods.
Training and treatment
Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.
Interventions
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Speech generating device (SGD) evaluation including BCI access
At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.
Training and treatment
Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.
Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
* age 14 and above
* able to read a standard computer screen
* able to follow instructions
* English as their native language
Exclusion Criteria
* open sores on the scalp
* history of uncorrectable hearing loss
* unavailable to participate during the times scheduled for the study
14 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
University of Pittsburgh
OTHER
Responsible Party
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Katya Hill
Associate Professor
Principal Investigators
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Katya Hill, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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AAC Institute Clinic (ICAN Talk Clinic)
Carnegie, Pennsylvania, United States
University of Pittsburgh, AAC Performance and Testing Laboratory
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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90IFDV0002-01-00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY19010094
Identifier Type: -
Identifier Source: org_study_id