Adaptive and Individualized AAC Phase II

Last updated: September 25, 2025
Sponsor: Altec Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Communication Disorders

Treatment

Experimental AAC

Generic AAC

Clinical Study ID

NCT06337188
AAC PhII
  • Ages > 6
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults or Children; age greater than or equal to 6 y.o.

  • Male or female

  • Able to (a) spell, (b) follow 2-3 step directions, (c) read 40 point text

  • Have complex communication needs representing a broad spectrum of developmental andacquired severe motor impairments resulting from high spinal cord injury (SCI),chronic Guillain-Barre syndrome, brain stem stroke, cerebral palsy (CP), locked-insyndrome, among others.

  • Requires the use of an alternative access strategy to communicate and/or usetechnology that has been clinically prescribed and manually optimized followingcurrent clinical standards.

  • Sufficient control and voluntary muscle activation on either the head, hand, or foot (on the basis of clinical evaluation by clinical collaborators at University ofNebraska Medical Center) to use the proposed wearable AAC system for the purpose ofthis study.

  • Sufficient stamina and developmental maturity (on the basis of clinical evaluationby clinical collaborators at University of Nebraska Medical Center) to attend to theapproximately 1-2 hour protocols outlined in Aims 2 and 3 without excess fatigue ordistraction.

  • Availability for at least 5 testing sessions over the study period.

  • No medical or safety restrictions of active head, hand, or foot movement (asdetermined by clinical collaborators at University of Nebraska Medical Center).

  • Clinical evidence of preserved cognition by a score of 0 or 1 on NIHSS Consciousnessand Communication item.

  • Ability to voluntarily blink eyes or raise eyebrows on command (for head selection)or contract fingers/hand grasp (for hand selection) or rotate foot (for footselection).

  • Able to provide written, informed consent or an accompanying communication partneror parent/guardian (for individuals under 18 y.o) to provide written, informedconsent/assent to participate in the study.

  • Able to speak and follow directions in English.

Exclusion

Exclusion Criteria:

  • Non-English speaker.

  • Inability to follow simple instructions in English.

  • Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) thatcauses pain on head, hand, or foot movement.

  • Restricted active or passive rotation of head and neck resulting from unstablevertebral, spinal cord, or nerve roots that places the subject at risk for executionof the protocol.

  • Medical history of cardiac or respiratory complications, or similar disorders thatwould severely reduce stamina and/or place the subject at risk for conducting thedifferent motor activities.

  • Unable to provide informed assent/consent in English.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Experimental AAC
Phase:
Study Start date:
December 03, 2024
Estimated Completion Date:
March 01, 2026

Study Description

The investigators propose an AAC device comprising a versatile access method that automatically learns and customizes a keyboard interface to the residual motor function of the individual. The team comprising scientists, speech researchers and clinicians is developing a prototype AAC system comprising versatile access method and personalized, comprehensive communication software. This will be achieved by developing hardware to support streamlined access across multiple points on the body, designing automated algorithms to rapidly create an expanded AAC interface, inclusive of letters, numbers, symbols, emojis, and word completion options, that is personalized based on the residual motor function of user-specific access points, creating software for point-of-care use of the access technology and interface, and evaluating the resulting AAC system for communication efficacy in individuals with severe motor impairments. The milestone will be to demonstrate that our AAC system improves Information Transfer Rate (ITR) and user experience over conventional AAC devices. The final AAC deliverable will be easily integrated with existing AAC tablets and mobile devices to provide those in need of alternative communication methods with an automatically customized, efficient, and intuitive solution to restore communication access in their daily lives. The project's involvement of human subjects for the purpose of research is primarily focused on testing our AAC system for usability, improved performance, acceptance, and perceived benefit among individuals with severe motor impairments.

Connect with a study center

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 68198
    United States

    Active - Recruiting

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