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Active, Not Recruiting

NCT Number: NCT07151950

Obi Medical Robot: Evaluating Effectiveness Related to Usability

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Upper Extremity Impairments ALS - Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral Palsy (CP) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Rett Syndrome Spinal Cord Diseases TDP-43 Proteinopathies X-Linked Intellectual Disability

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Desin, Llc

Jacksonville, Florida, 32256, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-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

Device

This study explores the stakeholders' experiences in recommending and using Obi. Stakeholders/Participants include:

  • Persons with disabilities or conditions which prevent them from successfully using their upper extremities (UE) to self-feed independently
  • Caregivers of the persons with disabilities described above
  • Providers (OT, SLP, PT, ATP, etc.) who provide services to persons with disabilities

Primary outcomes

  1. System Usability Scale

    Time frame: 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.

  2. Non-Standardized, Custom Survey

    Time frame: 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

  3. Functional Eating Status

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Desin LLC

Industry

Collaborators

  • The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC

Registry information

Official study title

Obi Medical Robot: Evaluating Effectiveness Related to Usability in Providers, Caregivers & Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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