Adaptive and Individualized AAC Phase II
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Communication Disorders
- 发起方
- Altec Inc.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Information Transfer Rate
- 状态
- 招募中
- 最后更新
- 7个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Information Transfer Rate
时间窗: 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
时间窗: 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.
Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT)
时间窗: 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.
次要结局
- 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)