Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Performance Outcomes (PerfOs)
研究概览
简要总结
Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI).
This assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes.
The tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrollment will involve three different cohorts, namely a cohort of healthy participant, a cohort of ALS/SCI participant who underwent the implant of an invasive BCI device, and a cohort of ALS/SCI participants without any implanted BCI device.
- •Below are listed the inclusion and
排除标准
- •for each diagnostic group.
- •Spinal Cord Injury (SCI):
- •Inclusion Criteria:
- •Age at or above 18 years old;
- •Diagnosis of spinal cord injury, at the level of T1 or above levels (between C1 and T1);
- •Ability to communicate independently or with a support device, or with a legal representative;
- •Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.
- •Exclusion Criteria:
- •Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- •Amyotrophic Lateral Sclerosis (ALS):
- •Inclusion criteria:
- •Age at or above 18 years old;
- •Diagnosis of amyotrophic lateral sclerosis;
- •Ability to communicate independently, with a support device, or with a legal representative;
- •Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.
- •Exclusion criteria:
- •● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- •Healthy Controls:
- •Inclusion criteria:
- •Age at or above 18 years old;
- •No history of neurological or psychiatric disorders;
- •Ability to provide written informed consent;
- •Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.
- •Exclusion criteria:
- •Participation in another trial that would conflict with the current study or clinical endpoint interference may occur;
- •Cognitive, visual, or auditory deficits that would interfere with study participation;
- •Current or prior diagnosis or condition that could confound study assessments.
研究组 & 干预措施
AT/BCI User
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
干预措施: Eye Tracker (Device)
AT/BCI User
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
干预措施: Mouth Operated Joystick (Device)
AT/BCI User
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
干预措施: Non-invasive electroencephalogram (EEG) Headset (Device)
AT/BCI User
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
干预措施: Implantable Brain-Computer-Interface (Device)
AT/BCI User
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
干预措施: Personal Assistive Technology (Device)
AT/BCI User
Participants in this arm will undergo training and a digital assessment using 3 assistive technologies (eye tracker, mouth-operated joystick, non-invasive electroencephalogram (EEG) headset), brain-computer-interfaces, and applicable personal ATs. Participants will experience each of these devices in a randomized order. Participants in this arm will include individuals with a diagnosis of amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), or healthy individuals.
干预措施: Voice Control (Device)
结局指标
主要结局
Performance Outcomes (PerfOs)
时间窗: Through study completion, every visit during the Digital Assessment Interface.
Quantitative metrics will be extracted from a customized Digital Assessment Interface simulating digital activities of daily living (dADLs, e.g., online shopping, texting, gaming, booking appointments). Metrics will be collected for each motor primitive (clicking, scrolling, typing, click-and-drag) to evaluate performance, including click accuracy, time to target, number of errors, cursor trajectory, words per minute, and percentage of correct letters/characters.
Demographics and Medical Intake Questionnaire
时间窗: Day 1
Demographic characteristics such as age and sex will be considered for index development (primary objective), along with level of education and race/ethnicity for index validation and characterization of Assistive Technology/Brain Computer Interface systems (secondary objective). Medical intake information, including diagnosis, will be considered for index development (primary), validation (secondary), and device characterization (secondary).
NASA Task Load Index
时间窗: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.
A self-report questionnaire for measuring the perceived workload of the use of each assistive technology across 6 domains: mental demand, physical demand, temporal demand, performance, effort, and frustration. This will be conducted to inform index development (primary objective) as well as validation and device characterization (secondary objectives).
NASA Task Load Index - Clinician's perspective
时间窗: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.
A self-report questionnaire for measuring the perceived workload of the use of each assistive technology across 6 domains: mental demand, physical demand, temporal demand, performance, effort, and frustration. This will be conducted as a clinician-reported outcome, where the clinician will evaluate the participant's level of fatigue in performing digital activities of daily living. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).
System Usability Scale (SUS)
时间窗: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.
A brief 10-item questionnaire that measures a system's overall perceived usability. Items are rated on a 5-point Likert scale to measure ease of use, complexity, and user experience. This will be conducted as an outcome measure for index development (primary objective) as well as validation and device characterization (secondary objectives).
System Usability Scale (SUS) - Clinician's perspective
时间窗: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.
A brief 10-item questionnaire that measures a system's overall perceived usability. Items are rated on a 5-point Likert scale to measure ease of use, complexity, and user experience. This will be conducted as a clinician-reported outcome, where the clinician will evaluate the participant's usability of the experimental device in performing digital activities of daily living. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).
Qualitative Questionnaire
时间窗: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface.
Modified version of the Canadian Occupational Performance Measure (COPM) to better capture functional digital independence. The qualitative questionnaire is conducted via a semi-structured interview to help participants identify goals in the area of digital independence and rate their performance and satisfaction on a scale. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).
Psychosocial Impact of Assistive Devices (PIAD)
时间窗: Through study completion, every visit after an attempt or completion of the Digital Assessment Interface
Self-report questionnaire designed to measure the effects of an assistive device on functional independence, well-being, and quality of life. It is a patient-reported outcome measure that assesses perceptions of competence, adaptability, and self-esteem, helping to understand the user's experience and predict device adoption/abandonment. This measure will be used to inform index development (primary objective) as well as validation and device characterization (secondary objectives).
次要结局
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(Day 1)
- Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)(Day 1)
- Clinical Evaluation(Day 1)
- Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Section GG(Day 1)
- Edinburgh Cognitive and Behavioral ALS Screen (ECAS)(Day 1)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF)(Day 1)
研究者
Arun Jayaraman, PT, PhD
Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research
Shirley Ryan AbilityLab