Upper Extremity ImpairmentsNCT07151950
Obi Medical Robot: Evaluating Effectiveness Related to Usability
An observational study of Upper Extremity Impairments and Cerebral Palsy (CP), run by Desin LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Upper Extremity Impairments, Cerebral Palsy (CP), ALS - Amyotrophic Lateral Sclerosis
- What is being tested?
- 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
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Obi Medical Robot: Evaluating Effectiveness Related to Usability in Providers, Caregivers & Patients
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.
Read the 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.
- Conditions
- Upper Extremity Impairments, Cerebral Palsy (CP), ALS - Amyotrophic Lateral Sclerosis, Rett Syndrome
- Being tested
- 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
- Keywords
- upper extremity impairments, Robot Assisted Feeding, assistive technology, usability
- Medical subject headings
- Cerebral Palsy, Amyotrophic Lateral Sclerosis, Rett Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 utensilsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Providers who recommend Obi | Not described | |
| 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 Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: One week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start10 May 2025
- Primary completion12 Aug 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ImpairmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desin LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC
- Responsible party
- Principal investigator, Andrea Fairman, The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151950
- Sponsor's protocol ID
- IFD-DES-081
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obi Medical Robot: Evaluating Effectiveness Related to Usability in Providers, Caregivers & Patients
- ClinicalTrials.gov ID
- NCT07151950
- Acronym / sponsor ID
- IFD-DES-081
- Conditions
- Upper Extremity Impairments, Cerebral Palsy (CP), ALS - Amyotrophic Lateral Sclerosis, Rett Syndrome
- Keywords
- upper extremity impairments, Robot Assisted Feeding, assistive technology, usability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Desin LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Driving Doctor: Adaptive Driving & Rehabilitation Solutions, PC
- Study start
- 10 May 2025 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Providers who recommend Obi | – | – |
| Caregivers of Persons 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 utensilsCaregivers 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 | – | 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 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 utensilsThis 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 | Device | Caregivers of Persons who trial Obi, Persons with Disabilities who trial Obi |
Primary outcome
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Impairments and Cerebral Palsy (CP), run by Desin LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: one week post trial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.