Evaluating Safety and Effectiveness of Intelligent Powered Exoskeletons for Rehabilitation After Spinal Surgery in Adults

What this Trial Is About

This research aims to evaluate the safety and effectiveness of an intelligent powered exoskeleton designed to help patients regain lower limb function after spinal surgery. The study focuses on patients who have motor disorders in both legs following surgery for conditions like degeneration, tumor, or trauma. The goal is to compare different rehabilitation approaches and provide data to support future clinical studies. Participants are randomly assigned to one of two groups one group will perform rehabilitation exercises using the powered exoskeleton device, while the other group will undergo traditional rehabilitation exercises without the exoskeleton. The study is conducted at a single center and follows patients for up to 12 months to assess various outcomes. During the study, participants will undergo several tests and measurements at 3 months, including a six-minute walk test, muscle strength evaluation, walking speed tests, hip joint mobility, stride length, heart rate changes, and oxygen levels. Safety is monitored through the recording of adverse events over 12 months. This comprehensive monitoring helps researchers understand how well the exoskeleton supports recovery and its safety profile over time.

A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation