Obi Medical Robot: Evaluating Effectiveness Related to Usability in Providers, Caregivers & Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- System Usability Scale
研究概览
简要总结
This mixed-methods usability study evaluates the effectiveness of the Obi Gen 3 robotic feeding device in meeting user needs among providers, caregivers, and patients. Participants will complete a one-week trial using Obi in home, school, or community settings, followed by feedback surveys and optional interviews. The study seeks to validate that the device design meets usability requirements prior to broader deployment.
详细描述
The study assesses the usability of Obi Gen 3 through quantitative surveys and qualitative interviews across three user groups: providers, caregivers, and patients. Measures include the System Usability Scale (SUS), questions based on the Matching Person & Technology (MPT) assessment and framework, and a custom Obi Medical Device Needs Assessment (MDNA). Data collection includes pre-trial in-office screening and post-trial surveys gathered remotely using Qualtrics. Optional follow-up interviews gather further feedback. The study aims to verify that the Obi Gen 3 meets its intended use and user needs in real-world environments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Providers with relevant expertise to recommend and evaluate patients' ability to use Obi
- •Caregivers directly assisting users with Obi
- •Adults or children (≥5 years) needing assistive feeding technology to self-feed
排除标准
- •Inability to provide informed consent/assent
- •Cognitive impairments that may prevent the ability to understand or respond to the survey questions
- •Non-English speakers (English-only materials)
- •Residents of California who are new Obi users
结局指标
主要结局
System Usability Scale
时间窗: one week post trial
The System Usability Scale (SUS) is a widely used, reliable tool for measuring the usability of a product or system. It consists of a 10-item questionnaire with a five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree." SUS provides a single score on a scale from 0 to 100 that reflects the overall ease of use and user satisfaction. Developed by John Brooke in 1986, the SUS is technology-agnostic and can be applied across a wide range of systems, including software, websites, and assistive technologies. Its simplicity, robustness, and versatility make it a standard in usability evaluation.
Non-Standardized, Custom Survey
时间窗: one week trial
Another primary outcome for this study is stakeholder-reported usability of the Obi Gen 3 device, as assessed by structured, study-specific surveys developed for this clinical investigation. Separate but parallel survey instruments were created for patients, caregivers, and clinicians/providers to capture device performance and user experience from multiple perspectives. Each survey includes both closed-ended and open-ended questions addressing: * Ease of use - learning to operate the device, understanding controls, and integrating it into mealtime routines * Effectiveness - ability to self-feed, control bite timing and size, and accommodate a variety of foods * Satisfaction - overall impressions, perceived benefits, and willingness to recommend the device * Safety and comfort - perceived safety during operation, confidence in device reliability, and comfort while using the device * Suggestions for improvement - opportunities for design or functionality enhancements
Functional Eating Status
时间窗: One week trial
Functional eating status is measured by the clinical provider at baseline (without use of Obi) and again one week post-trial (with use of Obi). The participants' level of performance is assessed on a Likert Scale as follows: 0 - No problem, 1 - Mild, 2 - Moderate, 3 - Severe, 4 - Complete
次要结局
未报告次要终点
研究者
Andrea Fairman
Principal Investigator & Research Consultant
The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC