The objective of this research was to evaluate the effectiveness and safety of Lower Extremity Exoskeleton Robot improving walking function and activity in patients with complete spinal cord injury. A prospective, open and self-controlled trial was conducted which include eight patients with complete spinal cord injury accepted Lower Extremity Exoskeleton Robot training with Aider 1.0 and Aider 1.1 for 2 weeks. The 6[Formula: see text]min Walk Test (6MWT), 10[Formula: see text]m Walk Test (10 MWT), Hoffer walking ability rating, Lower Extremity Motor Score (LEMS), Spinal Cord Independence Motor (SCIM), Walking Index for Spinal Cord Injury Version II (WISCI II) were recorded before, 1 week and 2 weeks after training. During the training, the incidence of adverse events (AE), the incidence of serious adverse events (SAE), the incidence of device defects and other safety indicators were observed. Compared with the pre-training, indicators (6MWT, 10MWT, Hoffer walking ability rating, WISCI II) were significantly different after 1 week of training and after 2 weeks of training. Four adverse events occurred during the training period and the incidence of adverse events was 50%. And there was no SAE or device defects. Therefore, it is safe and effective to use the lower extremity exoskeleton robot to complete the walking ability of patients with complete spinal cord injury.
