Safety assessment and feasibility of the TWIICE powered exoskeleton for assisted ambulation in individuals with spinal cord injury.

Only five non-ambulatory participants completed the study, after four consented participants were excluded for insufficient bone mineral density. The study was single-arm and open-label, with no control group, so observed changes cannot be compared with usual care or another exoskeleton. The sample was young, physically fit and highly selected by height, weight, crutch ability, standing tolerance and bone mineral density. It cannot be applied to the broader spinal cord injury population. Mobility tests were done only in the final session, so they indicate ability to operate the device after limited training, not clinical progress. Therapist assistance ratings were subjective, and the threshold between minimal and moderate assistance can vary between therapists. Sponsor team members were frequently present during training and assessments, which may have influenced usability feedback and performance. Smaller participants experienced reduced stability and control when the device did not fit snugly around the hips. The device still requires crutches and an accompanying person, limiting hands-free daily activities and independent community use.

No formal funding or conflict-of-interest declaration is given. The sponsor's device was tested, TWIICE SA provided the device app, and sponsor team members supported training and assessments.

Do not conclude that the TWIICE exoskeleton alone restores walking or improves health. Participants trained with therapist support, crutches and sponsor assistance, and the study had five non-ambulatory participants, no control group, and mobility tests only after six supervised sessions.