Adaptive and Individualized AAC Phase II

NCT06337188 | Recruiting

• 1 other identifier: AAC PhII
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• Information Transfer Rate

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

  1 year

• 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.

  1 year

Secondary Outcomes (4)

• Character-to-character Movement Time

  1 year

• Path Efficiency

  1 year

• Frequency of Selecting Word Completion Options

  1 year

• Number of Written Disfluencies

  1 year

Study Arms (1)

Experimental and Generic Communication Interfaces for AAC

EXPERIMENTAL

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

Device: Experimental AAC; Device: Generic AAC

Interventions

Experimental AAC DEVICE

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.

Experimental and Generic Communication Interfaces for AAC

Generic AAC DEVICE

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.

Experimental and Generic Communication Interfaces for AAC

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Altec Inc.: lead
• University of Nebraska: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gianluca De Luca, M.S.

  Altec Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhawna Shiwani, M.S.

CONTACT

5085458217; bshiwani@altecresearch.com

Joshua Kline, Ph.D.

CONTACT

5085458212; jkline@altecresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 29, 2024
• Study Start: December 3, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)