{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T16:06:47Z","timestamp":1789574807184,"version":"build-2803163510"},"reference-count":44,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Rehabil Assist Technol"],"abstract":"\n Background<\/jats:title>\n Loss of self-feeding ability due to severe bilateral upper extremity motor impairment (BUEMI) limits functional independence with a critical activity of daily living, increases medical risks, reduces social participation, and affects overall well-being. Robotic feeding devices are an emerging category of assistive technology. Obi3 is a third-generation, robotic feeding device, regulated in the United States as a Class I medical device and CE marked as a Class I device under the European Union Medical Device Regulation. The device is designed to enable people with BUEMI to independently select and safely consume food and liquid using accessible switches or interfaces while maintaining culturally normative dining practices. Although earlier Obi generations showed promise, comprehensive usability data across multiple stakeholder groups remains limited.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study evaluated the usability, safety, and clinical relevance of Obi3 in real-world use from the perspectives of people with BUEMI, caregivers, and rehabilitation providers. The findings were intended to generate evidence to inform clinical decision-making and determinations of medical necessity for potential DME coverage, consistent with the device\u2019s intended use and clinician-assessed implementation.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n A mixed methods usability study provided a 1-week home trial of Obi3. Quantitative measures included the System Usability Scale (SUS), survey items adapted from the Matching Person and Technology (MPT) framework, and self-feeding ratings based on the International Classification of Functioning, Disability, and Health impairment scale. Paired-sample t tests, Wilcoxon signed-rank tests, and effect sizes (Cohen d) assessed changes in self-feeding scores. Qualitative data from open-ended survey responses and follow-up semistructured interviews were analyzed thematically to complement quantitative findings.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 50 participants were enrolled, of whom 42 completed follow-up surveys. Participants included 15 people with BUEMI (pediatric and adult), 14 caregivers, and 13 providers. Participants\u2019 mean self-feeding impairment scores decreased significantly from 3.80 (SD 0.41) at baseline to 0.60 (SD 0.74) post trial (n=15; t14=10.75; P<.001; Cohen d=3.40). All patient participants demonstrated improvement in functional self-feeding ability. Mean SUS scores exceeded the benchmark for acceptable usability (\u226568) across stakeholder groups: 82.8 (SD 17.2) for people with BUEMI, 85.2 (SD 12.6) for caregivers, and 85.0 (SD 10.7) for providers. Responses to MPT items indicated strong alignment between user goals and device capabilities, perceived safety, and low complexity. Caregivers reported reduced feeding-related workload and stress, and providers endorsed ease of clinical integration. No adverse events or device malfunctions occurred.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Obi3 demonstrated high usability, safety, and clinical use in restoring self-feeding independence among individuals with severe BUEMI. Findings across people with BUEMI, caregivers, and providers support Obi3 as an effective DME that may enhance user autonomy and reduce caregiver burden. Lengthier longitudinal studies are needed to establish long-term clinical efficacy and health outcomes.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/86338","type":"journal-article","created":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T08:30:10Z","timestamp":1782376210000},"page":"e86338","source":"Crossref","is-referenced-by-count":0,"title":["Usability and Functional Outcomes of the Obi3 Robotic Feeding Device Among People With Disabilities, Caregivers, and Providers: Mixed Methods Study"],"prefix":"10.2196","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6777-5391","authenticated-orcid":false,"given":"Andrea D","family":"Fairman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4836-2726","authenticated-orcid":false,"given":"Ryan B","family":"Osal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-0002-5001","authenticated-orcid":false,"given":"Heather","family":"Keeton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0712-5517","authenticated-orcid":false,"given":"Jonathan P","family":"Dekar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"ref1","year":"2001","journal-title":"International Classification of Functioning, Disability and Health (ICF)"},{"key":"ref2","unstructured":"Occupational therapy practice framework: domain and process. 4th edAmerican Occupational Therapy Association20202025-09-01Bethesda, MDAOTA Presshttps:\/\/www.aota.org\/practice\/domain-and-process\/framework"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.5014\/ajot.2017.716S04"},{"key":"ref4","author":"Hammell, KW","year":"2020","journal-title":"Canadian Journal of Occupational Therapy"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.5014\/ajot.2018.025353"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1093\/ptj\/pzab112"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.3389\/fnhum.2017.00130"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1101\/cshperspect.a024117"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1177\/2329048X211008725"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1186\/s12984-023-01277-7"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-02940-9"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1177\/0008417420925995"},{"issue":"2","key":"ref13","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1046\/j.1365-2702.2001.00479.x","volume":"10","author":"Westergren, A","year":"2001","journal-title":"J Clin Nurs"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1186\/s40795-020-00335-w"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1186\/s12912-023-01575-4"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1002\/jpen.2679"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1145\/3568162.3576988"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1080\/09638288.2024.2302582"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare12212105"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1007\/s12603-019-1243-5"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1016\/j.jnha.2025.100522"},{"key":"ref22","unstructured":"Assistive Technology Act of 1998, 29 U.S.C. \u00a73001Office of the Law Revision Counsel2026-06-30https:\/\/uscode.house.gov\/view.xhtml?path=\/prelim@title29\/chapter31&edition=prelim"},{"key":"ref23","author":"Cook, AM","year":"2020","journal-title":"Assistive Technologies: Principles and Practice"},{"key":"ref24","unstructured":"Product classification database: ILC' daily activity assist device, eatingUS Food and Drug Administration20252025-10-03https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?ID=ILC"},{"key":"ref25","unstructured":"MealtimePMealtime partner adaptive feeding equipmentMealtime Partners, Inc20252025-10-08https:\/\/www.mealtimepartners.com"},{"key":"ref26","unstructured":"Neater eater robotic feeding systemNeater Solutions Ltd2025-10-08Neater Solutions Ltdhttps:\/\/www.neater.co.uk"},{"key":"ref27","unstructured":"Obi robotic feeding deviceDES\u012aN LLC2025-10-03https:\/\/meetobi.com"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.1109\/TNSRE.2016.2603472"},{"key":"ref29","unstructured":"IEC 60601-1-11:2020-Amendment 1 - 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