Adaptive and Individualized AAC Phase II

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT) [Срок оценки: 1 year]
• Information Transfer Rate [Срок оценки: 1 year]
• National Aeronautics and Space Administration (NASA) Task Load Index [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Character-to-character Movement Time [Срок оценки: 1 year]
• Path Efficiency [Срок оценки: 1 year]
• Frequency of Selecting Word Completion Options [Срок оценки: 1 year]
• Number of Written Disfluencies [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Nebraska Medical Center — Omaha

Идентификаторы

NCT: NCT06337188 · AAC PhII

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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