Actively Recruiting

Phase Not Applicable
Age: 6Years +
All Genders
ID06337188

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

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

At least 1 visit to confirm eligibility and consent

Implementation

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

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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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