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RecruitingNCT06337188Updated Sep 30, 2025

Adaptive and Individualized AAC Phase II

An interventional study of Experimental AAC and Generic AAC in Communication Disorders, sponsored by Altec Inc.. Recruiting at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Altec Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
6 Years and older
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Communication Disorders
03

In context

Communication Disorders

149 studies on the registry are indexed under Communication Disorders; 44 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 124 interventional studies indexed under Communication Disorders.

Browse Communication Disorders studies →

Lead sponsor

Altec Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental and Generic Communication Interfaces for AAC

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

    Device: Experimental AAC · Device: Generic AAC

Interventions

  • DeviceExperimental 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.

  • DeviceGeneric 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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 1 year

  2. Information Transfer Rate

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

    Time frame: 1 year

  3. National Aeronautics and Space Administration (NASA) Task Load Index

    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.

    Time frame: 1 year

Secondary outcomes

  1. Character-to-character Movement Time

    Measures the duration in seconds required to move a cursor to a specified target on a computer screen.

    Time frame: 1 year

  2. Path Efficiency

    Measures the ratio of an ideal cursor path between targets to the actual path traveled.

    Time frame: 1 year

  3. Frequency of Selecting Word Completion Options

    Measures the number of times per session a predicted word is chosen in place of spelling out the individual letters of the word.

    Time frame: 1 year

  4. Number of Written Disfluencies

    Measures the number of times per session a target is substituted, inserted, or deleted as well as the number of pauses between target selections.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Mar 2026, 14 months after the start.

Of 80 interventional studies with no phase under Communication Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2024
First posted
Mar 29, 2024
StartActual
Dec 3, 2024
Primary completionEst.
Mar 1, 2026
CompletionEst.
Mar 1, 2026
Last update
Sep 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06337188
Lead sponsor
Altec Inc.
Collaborators
University of Nebraska
Responsible party
Sponsor
First posted
Mar 29, 2024
Start date
Dec 3, 2024
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Sep 30, 2025

Study contacts

Bhawna Shiwani, M.S.
Contact
bshiwani@altecresearch.com
5085458217
Joshua Kline, Ph.D.
Contact
jkline@altecresearch.com
5085458212
Gianluca De Luca, M.S.
principal investigator · Altec Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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