Clinical trial NCT06337188: Adaptive and Individualized AAC Phase II
Official title: Adaptive and Individualized AAC Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Communication Disorders
Lead sponsor: Altec Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Nebraska
First posted: 2024-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
timeFrame: 1 year
measure: Information Transfer Rate
timeFrame: 1 year
measure: National Aeronautics and Space Administration (NASA) Task Load Index
timeFrame: 1 year
Secondary outcomes:
measure: Character-to-character Movement Time
timeFrame: 1 year
measure: Path Efficiency
timeFrame: 1 year
measure: Frequency of Selecting Word Completion Options
timeFrame: 1 year
measure: Number of Written Disfluencies
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: Altec Inc.
name: Gianluca De Luca, M.S.
role: PRINCIPAL_INVESTIGATOR
References: