Demonstration of a Training Protocol for Individuals with Tetraplegia and High Paraplegia Using a Self-Balancing Exoskeleton.

First-generation personal and home-use exoskeletal-assisted walking devices for individuals with spinal cord injury (SCI) require the use of forearm crutches or a walker and sufficient trunk control for balance and mobility, limiting their use among individuals with tetraplegia and high paraplegia. In addition, these devices typically permit only forward walking, which may restrict maneuverability in indoor environments. A self-balancing exoskeleton that provides trunk stability, enables standing and walking without an assistive walking device, permits hands-free activity, and allows forward, lateral, and backward stepping as well as bending and squatting was evaluated in individuals with tetraplegia and high paraplegia. A prospective, interventional, single-group, open-label study was conducted at two sites. Eligible participants with SCI and their companions who successfully completed screening evaluations were trained and evaluated as pairs. The protocol included participant screening, device fitting, four standardized training sessions, and competency evaluations. Training activities included device donning and doffing, standing and sitting, indoor and outdoor walking, ambulatory functions, activities of daily living, safety procedures, and device care and storage. Performance assessments included donning and doffing within 10 min, the timed-up-and-go (TUG) test within 3 min, and a distance of at least 40 m the 6-min walk test (6MWT). Among the first 16 participants who completed the protocol, all achieved the TUG and 6MWT performance goals, 15 achieved the donning goal after four training sessions, and all achieved the doffing goal. This article describes a standardized training protocol for individuals with tetraplegia and high paraplegia and their companions to safely operate a self-balancing exoskeleton for personal use.