Actively Recruiting
Adaptive and Individualized Augmentative and Alternative Communication (AAC) System Phase II Study for Communication Disorders
Led by Altec Inc. · Updated on 2025-09-30
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Altec Inc.
Lead Sponsor
U
University of Nebraska
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are developing an Adaptive and Individualized Augmentative and Alternative Communication (AAC) system designed to help individuals with severe motor impairments communicate more effectively. This study focuses on creating a personalized communication device that automatically adapts to the user's physical abilities by customizing a comprehensive keyboard interface. The goal is to improve communication access for people who rely on alternative methods due to conditions like spinal cord injury, cerebral palsy, or locked-in syndrome. Participants will use two types of AAC systems during the study: an Experimental AAC system featuring wearable sensors to detect movement and muscle activity for cursor control and selection, integrated with an adaptive keyboard; and a Generic AAC system similar to devices they normally use, such as eye-tracking with a generic keyboard. Each participant will use both systems in sequence to compare communication performance, with the Experimental AAC aiming to enhance information transfer and user experience. During the study, participants will attend approximately 5 testing sessions involving the use of these AAC systems over about one year. Researchers will assess communication effectiveness using tools such as the Tele-healthcare Satisfaction Questionnaire, Information Transfer Rate measurement, and the NASA Task Load Index. Additional evaluations include character movement time, path efficiency, word completion usage, and writing fluency. The study will monitor usability, acceptance, and benefits of the AAC system for people with severe motor challenges.
CONDITIONS
Brief Title
Adaptive and Individualized AAC Phase II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults or children aged 6 years or older
- Any gender
- Able to spell, follow 2-3 step directions, and read 40 point text
- Have complex communication needs due to severe motor impairments from conditions like spinal cord injury, Guillain-Barre syndrome, brain stem stroke, cerebral palsy, or locked-in syndrome
- Require use of an alternative access method for communication or technology optimized by clinical standards
- Have sufficient voluntary muscle control in head, hand, or foot to use the wearable AAC system
- Have enough stamina and developmental maturity to participate in 1-2 hour testing sessions
- Available for at least 5 testing sessions during the study
- No medical or safety restrictions on active head, hand, or foot movement
- Clinical evidence of preserved cognition with a score of 0 or 1 on NIHSS Consciousness and Communication item
- Ability to voluntarily perform specific movements like blinking eyes, raising eyebrows, contracting fingers, or rotating foot
- Able to provide written informed consent or have a communication partner or guardian provide consent/assent
- Able to speak and follow directions in English
You will not qualify if you...
- Non-English speakers
- Unable to follow simple instructions in English
- History of musculoskeletal conditions causing pain on head, hand, or foot movement
- Restricted head and neck movement due to unstable vertebral or nerve conditions that increase risk during testing
- History of cardiac, respiratory, or similar complications reducing stamina or increasing risk during motor activities
- Unable to provide informed consent or assent in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
At least 1 visit to confirm eligibility and consent
Duration - Up to 1 year
Participants use two AAC systems: first the Experimental AAC system with wearable sensors and an adaptive keyboard, then a Generic AAC system similar to their usual communication device, to evaluate communication performance.
Approximately 5 testing sessions, each lasting 1 to 2 hours
Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
B
Bhawna Shiwani, M.S.
J
Joshua Kline, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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