ALS - Amyotrophic Lateral Sclerosis, Cerebral Palsy (CP), Rett Syndrome, Upper Extremity Impairments
Conditions
Keywords
upper extremity impairments, Robot Assisted Feeding, assistive technology, usability
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOne-week trial of Obi Medical device, which provides robotic assistance with feeding to persons with upper extremity impairments who are unable to self-feed in the traditional manner using utensils
This study explores the stakeholders' experiences in recommending and using Obi. Stakeholders/Participants include: 1. Persons with disabilities or conditions which prevent them from successfully using their upper extremities (UE) to self-feed independently 2. Caregivers of the persons with disabilities described above 3. Providers (OT, SLP, PT, ATP, etc.) who provide services to persons with disabilities
Sponsors
The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC
Desin LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale | 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 | 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 | 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 |
Countries
United States
Outcome results
None listed