NCT06337188 · Altec Inc.
Adaptive and Individualized AAC Phase II
What this study 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.
View original scientific description
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.
Interventions
DEVICE
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.
DEVICE
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 measures
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
Time frame: 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 Rate
Time frame: 1 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 Index
Time frame: 1 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Omaha, Nebraska
Collaborators
University of Nebraska
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations