JMIR Publications

ABSTRACT

Background:

Loss of self-feeding ability due to severe upper extremity motor impairment (UEMI) limits independence, compromises nutrition, and reduces social participation. Robotic feeding devices are an emerging category of assistive technology. Obi3 is a 3rd generation, Class I durable medical equipment (DME) robot intended to compensate for the movement of a human arm to restore self-feeding performance. The device is designed to enable patients to independently select and 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.

Objective:

This study evaluated the usability, safety, and clinical relevance of Obi3 from the perspectives of patients, caregivers, and rehabilitation providers in real-world use. The findings were intended to generate evidence that informs clinical decision-making and determinations of medical necessity for DME consistent with the device’s FDA-cleared Indications for Use and clinician-supervised implementation.

Methods:

A mixed-methods usability study enrolled 50 participants, of whom 42 completed follow-up surveys after a one-week home trial of Obi3. Participants included 15 patients (pediatric and adult), 14 caregivers, and 13 providers. Quantitative measures included the System Usability Scale (SUS), survey items adapted from the Matching Person and Technology (MPT) framework, and self-feeding impairment ratings based on the International Classification of Functioning, Disability and Health (ICF). 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 semi-structured interviews underwent thematic content analysis to complement quantitative findings.

Results:

Patients’ mean self-feeding impairment scores decreased significantly from 3.80 (SD 0.41) at baseline to 0.60 (SD 0.74) posttrial (n = 15; t₍₁₄₎ = 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 (≥68) across stakeholder groups: patients, 82.8 (SD 17.2); caregivers, 85.2 (SD 12.6); and providers, 85.0 (SD 10.7). Responses to Matching Person and Technology (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.

Conclusions:

Obi3 demonstrated high usability, safety, and clinical utility in restoring self-feeding independence among individuals with severe UEMI. Findings across patients, caregivers, and providers support Obi3 as an effective piece of DME that enhances user autonomy and reduces caregiver burden. Future multisite and longitudinal research is warranted to confirm long-term outcomes, maintenance, and integration into rehabilitation practice. Clinical Trial: The study was approved by WCG IRB (protocol #20251472), and all participants provided informed consent.