Obi Medical Robot: Evaluating Effectiveness Related to Usability

Desin LLC

Status: Active, not recruiting

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

Treatments: 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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07151950

IFD-DES-081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 3 patient groups

Providers who recommend Obi

Caregivers of Persons who trial Obi

Description:

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

Treatment:

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

Treatment:

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