Motor and Autonomic Concomitant Health Improvements With Neuromodulation and Exercise Training: A RCT in Individuals With SCI

About this trial

This is a clinical trial recruiting individuals with spinal cord injuries to measure the effect of training in a robotic exoskeleton with and without electrical spinal cord stimulation on voluntary motor function. An exoskeleton is an externally worn powered robotic device to assist movement; this study uses a Lokomat model. Spinal cord stimulation is a technique for activating spinal cord nerve networks, in this case by way of skin-surface electrodes, applied at the lower back. If selected, participants will receive activity-based therapy three sessions/week for 12 weeks; this includes balance and gait training with complete assistance of the exoskeleton. All participants will use the exoskeleton, and will be assigned to one of two study groups: 1) performing the activity-based therapy with spinal cord stimulation; or performing the activity-based therapy with sham (inactive) spinal cord stimulation (participant will not know if the stimulation is on or not). Researchers will assess voluntary muscle contractions, balance, blood pressure, cardiovascular effects, bowel, bladder and sexual function, fatigue, and quality of life effects. Final testing will be performed after 14 weeks.