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Adaptive and Individualized AAC for Communication Disorders

This study is testing a new type of Augmentative and Alternative Communication (AAC) system, called Experimental AAC, for people with communication disorders. This system uses two wearable sensors to help you control a cursor with your movements and muscle activity, and it has a special keyboard that learns and adapts to your abilities. Researchers will compare this to a Generic AAC system, which is similar to what you might already use, like an eye-tracking device with a standard keyboard. The goal is to see if the Experimental AAC system improves how well you can communicate and if you are satisfied with using it. You might be able to join if you are at least 6 years old, can spell, follow simple directions, and read large text, and have complex communication needs due to conditions like spinal cord injury or stroke. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 20 participants. It compares two different AAC systems.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your satisfaction, information transfer rate, and task load will be measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06337188

Adaptive and Individualized AAC Phase II

Recruiting
NAAges 6+Interventional
Altec Inc.
~20 participants
Updated 2025-09-30 on ClinicalTrials.gov
What's tested:Experimental AACGeneric AAC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
Measured over 1 year
+2 more outcomes measured

Conditions

Communication Disorders

Explore related trials

Communication Disorder

Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Gianluca De Luca, M.S. · PRINCIPAL_INVESTIGATOR · Altec Inc.

Who to contact

Bhawna Shiwani, M.S.
[email protected]
5085458217
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)1 year

    Measures quantitative ratings on the TSQ-WT scale from a minimum rating of 0 to a maximum rating of 4, where the higher value means a better outcome.

  • Information Transfer Rate1 year

    Measures the speed in meters/second of accurately moving a cursor to a specified target on a computer screen.

  • National Aeronautics and Space Administration (NASA) Task Load Index1 year

    Measures qualitative ratings that are rated on an interval scale ranging from low (1) to high (100) of perceived user demand, performance, effort, and frustration.