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| Name | Class |
|---|---|
| The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Persons with Disabilities who trial Obi |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desin, Llc | Jacksonville | Florida | 32256 | United States |
Individual participant data (IPD) will not be shared due to the small sample size, the vulnerability of the pediatric population, and the inclusion of potentially identifiable health information. Data will be reported only in aggregate form to protect participant privacy and comply with applicable privacy regulations (e.g., HIPAA).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2025 | Aug 12, 2025 |
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|
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2025 | Aug 12, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D000690 | Amyotrophic Lateral Sclerosis |
| D015518 | Rett Syndrome |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020271 | Heredodegenerative Disorders, Nervous System |
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