Actively Recruiting

Phase Not Applicable
Age: 6Years +
All Genders
NCT06337188

Adaptive and Individualized AAC Phase II

Led by Altec Inc. · Updated on 2025-09-30

20

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

A

Altec Inc.

Lead Sponsor

U

University of Nebraska

Collaborating Sponsor

AI-Summary

What this Trial Is About

The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication.

CONDITIONS

Official Title

Adaptive and Individualized AAC Phase II

Who Can Participate

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 years or older
  • Male or female
  • Ability to spell, follow 2-3 step directions, and read 40 point text
  • Complex communication needs due to severe motor impairments from conditions such as spinal cord injury, Guillain-Barre syndrome, brain stem stroke, cerebral palsy, locked-in syndrome, or similar
  • Requires use of an alternative communication access strategy clinically prescribed and optimized
  • Sufficient voluntary muscle control on head, hand, or foot to use the wearable AAC system
  • Sufficient stamina and developmental maturity to complete 1-2 hour testing sessions without excess fatigue
  • Availability 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 NIHSS Consciousness and Communication score of 0 or 1
  • Ability to voluntarily blink eyes, raise eyebrows, contract fingers/hand, or rotate foot on command
  • Ability to provide written informed consent or have a communication partner/guardian provide consent if under 18
  • Ability to speak and follow directions in English
Not Eligible

You will not qualify if you...

  • Non-English speaker
  • Unable to follow simple instructions in English
  • Medical history of musculoskeletal conditions causing pain on head, hand, or foot movement
  • Restricted head and neck movement due to unstable vertebral or nerve conditions posing risk during protocol
  • Medical history of cardiac or respiratory problems severely reducing stamina or posing risk during motor activities
  • Unable to provide informed assent or consent in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

CONTACT

J

Joshua Kline, Ph.D.

CONTACT

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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