Obi Medical Robot: Evaluating Effectiveness Related to Usability

NCT07151950 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IFD-DES-081
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Impairments; Cerebral Palsy (CP); ALS - Amyotrophic Lateral Sclerosis; Rett Syndrome

Keywords

upper extremity impairments; Robot Assisted Feeding; assistive technology; usability

Outcome Measures

Primary Outcomes (3)

• System Usability Scale

  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.

  one week post trial

• Non-Standardized, Custom Survey

  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

  one week trial

• Functional Eating Status

  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

  One week trial

Study Arms (3)

Providers who recommend Obi

Caregivers of Persons who trial Obi

Caregivers who assist persons with disabilities who trial Obi are invited to share their perspectives and experiences in helping to set up the device, interpret instructions, and describe the experience of trialing Obi from their perspective as a caregiver

Device: 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

Persons with Disabilities who trial Obi

Device: 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

Interventions

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: 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

Caregivers of Persons who trial Obi; Persons with Disabilities who trial Obi

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll three key stakeholder groups to evaluate the usability of the Obi Gen 3 device: Pediatric and Adult Patients - Individuals aged 5 years and older with functional self-feeding impairments who are recommended for Obi use by a clinician. Patients must have sufficient cognitive and communication abilities to provide feedback directly or with assistance. Caregivers - Family members or paid support personnel who assist the patient with meals or device operation. Caregivers will provide insight into the impact of the device on mealtime routines, supervision needs, and caregiving burden. Clinicians/Providers - Healthcare professionals (e.g., occupational therapists, speech-language pathologists, rehabilitation specialists) who assess, recommend, or train patients in Obi use. Providers will evaluate device usability, safety, and integration into clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Desin LLC: lead
• The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC: collaborator

Study Sites (1)

Desin, Llc

Jacksonville, Florida, 32256, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Amyotrophic Lateral Sclerosis; Rett Syndrome

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator & Research Consultant

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 3, 2025
• Study Start: May 10, 2025
• Primary Completion: August 12, 2025
• Study Completion: October 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)