RCT of clinical outcomes of robotic exoskeleton rehabilitation in motor-incomplete SCI

Background: Robotic exoskeletons offer a promising tool for gait rehabilitation in individuals with spinal cord injury (SCI). However, evidence of their additive benefit over conventional therapy, particularly in non-acute, motor-incomplete SCI, remains limited. Objective: To evaluate the efficacy of the EKSO-GT™ exoskeleton, used in an “add-on” mode, on walking performance and related clinical outcomes compared to standard neurorehabilitation alone. Methods: In this randomized, controlled, multicenter trial, 36 patients with chronic, motor-incomplete SCI (AIS C/D, 1–5 years post-injury) were randomized to receive either 4 weeks of exoskeleton-assisted training followed by 4 weeks of standard rehabilitation (RC+E), or 8 weeks of standard rehabilitation alone (RC). The primary outcome was the proportion of participants achieving ≥ 10% improvement in walking speed (10-meter walk test) at 4 weeks. Secondary outcomes included gait endurance, muscle strength, spasticity, proprioception, pain and mood. Keywords: spinal cord injury, randomized controlled trial, exoskeleton, gait rehabilitation, neurorehabilitation