Recruiting

AAC System

Sponsor:

Altec Inc.

Code:

NCT06337188

Conditions

Communication Disorders

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Experimental AAC

Generic AAC

Study Details

Brief 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.

Conditions

Communication Disorders

Study ID

NCT06337188

Start date

Dec 3, 2024

Status verified date

Sep, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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 and acquired severe motor impairments resulting from high spinal cord injury (SCI), chronic Guillain-Barre syndrome, brain stem stroke, cerebral palsy (CP), locked-in syndrome, among others.
  • Requires the use of an alternative access strategy to communicate and/or use technology that has been clinically prescribed and manually optimized following current 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 of Nebraska Medical Center) to use the proposed wearable AAC system for the purpose of this study.
  • Sufficient stamina and developmental maturity (on the basis of clinical evaluation by clinical collaborators at University of Nebraska Medical Center) to attend to the approximately 1-2 hour protocols outlined in Aims 2 and 3 without excess fatigue or distraction.
  • Availability for at least 5 testing sessions over the study period.
  • No medical or safety restrictions of active head, hand, or foot movement (as determined by clinical collaborators at University of Nebraska Medical Center).
  • Clinical evidence of preserved cognition by a score of 0 or 1 on NIHSS Consciousness and 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 foot selection).
  • Able to provide written, informed consent or an accompanying communication partner or parent/guardian (for individuals under 18 y.o) to provide written, informed consent/assent to participate in the study.
  • Able to speak and follow directions in English.

Exclusion Criteria:

  • Non-English speaker.
  • Inability to follow simple instructions in English.
  • Medical history of musculoskeletal conditions (arthritis, spondylosis, etc.) that causes pain on head, hand, or foot movement.
  • Restricted active or passive rotation of head and neck resulting from unstable vertebral, spinal cord, or nerve roots that places the subject at risk for execution of the protocol.
  • Medical history of cardiac or respiratory complications, or similar disorders that would severely reduce stamina and/or place the subject at risk for conducting the different motor activities.
  • Unable to provide informed assent/consent in English.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Experimental and Generic Communication Interfaces for AAC

Each participant receives both Experimental and Generic AAC systems to communicate - in that order.

Interventions

Experimental AAC

Participant receives an AAC system comprising 2 wearable sensors for movement-mediated cursor control and muscle activity mediated cursor selection that is integrated with an adaptive and individualized keyboard to test communication performance.

Generic AAC

Participant receives an AAC system that is similar to that used to satisfy their normal daily communication needs such as an eye-tracking device with a generic AAC keyboard to test communication.

Primary outcome measure

  • Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) [ Time Frame: 1 year ]
  • Information Transfer Rate [ Time Frame: 1 year ]
  • National Aeronautics and Space Administration (NASA) Task Load Index [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Bhawna Shiwani, M.S.

5085458217bshiwani@altecresearch.com

Joshua Kline, Ph.D.

5085458212jkline@altecresearch.com

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Susan Fager, Ph.D.

402-559-0426sfager@unmc.edu

Jessica Gormley, Ph.D.

402-559-6460jessica.gormley@unmc.edu

More Information

Sponsor

Altec Inc.

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Altec Inc. on 2025-09-30.