Randomized, Crossover Clinical Trial on the Safety, Feasibility, and Usability of the ABLE Exoskeleton: A Comparative Study with Knee-Ankle-Foot Orthoses

Abstract

AbstractWearable exoskeletons are emerging as a new tool for gait training. However, comparisons between exoskeletons and conventional orthoses in terms of safety and feasibility are scarce. This study assessed the safety, feasibility, usability, and learning process of using the ABLE Exoskeleton in people with spinal cord injury (SCI) while comparing it with knee-ankle-foot orthoses (KAFOs). In this randomized, crossover clinical trial, 10 patients with chronic complete SCI (T4-T12) conducted a 10-session training and assessment protocol with each device: KAFOs and the ABLE Exoskeleton. Outcomes on safety (adverse events), and feasibility and usability (level of assistance, donning/doffing, therapy activities) were recorded for both devices. Evaluation sessions included standard clinical tests (Timed Up and Go, 10-Meter Walk Test, and 6-Minute Walk Test) to assess gait performance. The therapy metrics (number of steps, distance, gait speed, and standing and walking time) were recorded at each session for the robotic device. Participants quickly learned how to use the ABLE Exoskeleton, showing improvements in all therapy metrics (p<0.05) and the 6-Minute Walk Test (p<0.05). The robotic device reported less adverse events than KAFOs (17 and 31, respectively). Total donning and doffing time was 43 seconds faster with the robotic device using comparable levels of assistance. The time to complete the therapy activities was very similar between devices. Overall, participants needed 1 to 4 training sessions to perform essential therapy activities (sit/stand transitions, walking 10 meters, turning around) with both devices using minimum assistance or less. The results of this study show that it is feasible and safe for people with motor complete paraplegia due to SCI (T4-T12) to use the ABLE Exoskeleton for gait training in a rehabilitation hospital setting. The ABLE Exoskeleton proved to be safer than KAFOs in terms of adverse events, and as practical and easy to use as the conventional orthoses.