Development of a personalized communication device for individuals with severe motor impairments
Official title: Adaptive and Individualized AAC Phase II
Run by Altec Inc. · NCT06337188 · Data updated 2026-11-12
This study is testing a new communication device that adapts to the needs of people with severe motor impairments to help them communicate more easily.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Altec Inc. Industry-sponsored |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | December 3, 2024 |
| Main results expected | March 1, 2026 |
| Study ends | March 1, 2026 |
| Registry record updated | September 30, 2025 |
| Trial ID | NCT06337188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults and children aged 6 and older with complex communication needs due to severe motor impairments.
✕Probably not a fit
Patients without sufficient voluntary muscle activation or those who do not require alternative communication methods may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to create an Augmentative and Alternative Communication (AAC) system that adapts to the user's physical abilities, providing a customized keyboard interface for effective communication. The research team, consisting of scientists, speech researchers, and clinicians, will develop a prototype AAC device that learns and personalizes communication methods based on the user's residual motor function. The project will evaluate the AAC system's efficacy in improving communication rates and user experience compared to conventional devices, ultimately integrating the solution with existing AAC technologies for broader accessibility.
Why it matters
Potential benefit: If successful, this AAC system could significantly enhance communication capabilities for individuals with severe motor impairments.
How similar studies have gone: While similar AAC systems have been explored, this approach of personalized adaptation based on motor function is innovative and may offer new solutions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Gianluca De Luca, M.S. — Altec Inc.
- Study coordinator: Bhawna Shiwani, M.S.
- Email: bshiwani@altecresearch.com
- Phone: 5085458217
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.