Self-balancing Personal Exoskeleton for SCI (Site 2)

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

This personal exoskeleton, developed by Wandercraft as a new version of the Atalante X, offers a novel hands-free and self-balancing design, aiming at enhancing stability and mobility for users in daily activities. The study features an interventional, prospective, single-group, and open-label design, conducted over 3 to 4 weeks at two US research facilities. 24 subjects are required to complete the study. Anticipating a 15% dropout rate, the study will enroll 29 participants. Over the course of nine to ten scheduled visits, participants undergo a sequence of procedures, beginning with screening and device fitting. This is followed by five training sessions which conclude with an evaluation to issue a competency certificate to confirm the ability to use the device across all its "basic skills". Additionally, two sessions are dedicated to evaluating the exoskeleton's effectiveness outcomes, complemented by an extra practice session. Each visit lasts an average of 1.5 hours.