Self-balancing Personal Exoskeleton for SCI (WINY)

Safety of the device for its intended use and user population.

Collection and analysis of adverse events to evaluate the safety of the device for its intended use and user population, specifically for individuals with spinal cord injury (SCI) performing ambulatory activities hands-free, accompanied by a companion.

Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.

The TUG evaluates the time from starting in a seated position to stand-up, walk 3 meters, turn around, walk back 3 meters and sit down on indoor surface.

Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT).

The 6MWT measures the distance in meters traversed over 6 min, on indoor surface.

Proportion of subjects who can complete at least 4 out of the 6 Activities of Daily Living (ADLs), in various simulated environments and with the exoskeleton.

The ADLs are done standing in front of the countertop in the kitchen, in a simulated living room, taking a 50m walk in the outdoor environment, taking the elevator, in the bathroom and walking in a hallway and through a door to get to the next room.

Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less.

The 10MWT measures the time in seconds taken to walk 10 meters.

Proportion of users who pass the device "basic skills" certification evaluation at the end of visit 6.

During the Certification Evaluation, the users' performance in executing all the device usability critical tasks will be observed and assessed by the trainer to ensure they are performed correctly (i.e., executed safely, regardless of the level of companion assistance, that is documented but isn't a criterion for success). The "basic skills" certification evaluation is passed if all the device basic skills have been learnt through the previous training sessions with the device (visits 2-5) and the critical tasks are re-executed correctly during the evaluation at visit 6. The device basic skills cover device theoretical knowledge, proper setup and installation in the device, walking and other ambulatory functions on different surfaces, Activities of Daily Living in indoor and outdoor environment techniques on various surfaces, and safety features such as emergency extraction.

Number of users who successfully master the different basic skills at a given visit.

For each basic skill, the visit number at which users are confirmed to have safely mastered the task is recorded on a "checklist", which lists all the device basic skills and is provided to the trainer. The goal is to track the users' learning progress and mastery of the device over time.

Evaluation of the assistance level provided by companion.

Assistance provided by the companion when mastering each basic skill on the checklist at initial learning, at the certification evaluation, during the additional practice session and when performing each test. A 3-point scale based on the Functional Independence Measure (FIM) score, tailored to the device and its progression stage will be used: 1-Maximal assistance: The companion provides support with both hands touching the device and/or the user almost continuously. 2- Moderate assistance - The companion provides support with one or both hands touching the device and/or the user intermittently. 3- Close contact guard/no assistance - The companion does not touch the device and/or the user but is close enough to assist if needed.

Overall Rating of Perceived Exertion (RPE) assessed with the Borg RPE scale by the users for the entire session.

The Borg scale rates the perceived exertion between 6 and 20 (very very light to very very hard exertion). The SCI users and their companions are asked to give their rating for the entire session, separately.