Study of Combined Powered Exoskeleton and Functional Electrical Stimulation for Adults with Chronic Spinal Cord Injury to Improve Walking and Mobility

What this Trial Is About

Researchers are investigating the use of a powered exoskeleton combined with functional electrical stimulation FES for people with chronic spinal cord injury SCI. This trial compares the combined therapy to exoskeleton therapy alone to assess improvements in walking and other health functions. The study addresses the potential benefits of merging over-ground robotic therapy with FES, which individually have shown positive effects on muscle strength, endurance, and mobility after SCI. Participants will be randomly assigned to one of two groups one will train with the EksoNR powered exoskeleton combined with gait-synchronized FES using the FES RehaMove2 device, and the other will train with the EksoNR exoskeleton alone. Training lasts 8 weeks, with three sessions per week, each session involving 30 minutes of active training. The trial evaluates how combining these therapies affects functional outcomes and secondary health parameters compared to exoskeleton therapy without FES. During the study, participants walking speed, gait function, endurance, balance, muscle strength, and quality of life will be assessed before training, immediately after the 8-week training, and again three months later. Researchers will also monitor training duration, intensity, volume, and cardio-respiratory function throughout the program. The main outcome measured is the change in preferred walking speed shortly after training, with additional measures collected over time to evaluate lasting effects.

Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT