Exoskeleton-Assisted Walking + Spinal Cord Stimulation for Spinal Cord Injury

This trial tests a new approach to improve muscle and bone health in people with chronic spinal cord injuries. Participants will use a robotic exoskeleton to assist with walking, combined with spinal cord stimulation, to determine its effect on musculoskeletal health. The trial will compare the effects of real spinal cord stimulation to a sham version to identify which is more effective. This trial may suit individuals who have relied on a wheelchair for more than three years due to a spinal cord injury and can grip crutches or a walker. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to innovative treatments for spinal cord injuries.

Yes, if you are currently prescribed any medications that can affect muscle and/or bone metabolism, you will not be eligible to participate in the trial.

Research has shown that using a robotic walking device, known as an exoskeleton, combined with a technique that stimulates the spinal cord through the skin, may help people with spinal cord injuries become more active. In a study involving individuals with partial spinal cord injuries, this combination was generally well-received, and no serious side effects occurred.

Researchers are excited about these treatments for spinal cord injury because they combine innovative technologies to enhance mobility. Unlike traditional rehabilitation that mainly focuses on physical therapy, this approach integrates exoskeleton-assisted walking with spinal cord stimulation. This combination is designed to potentially reactivate neural pathways and improve walking ability more effectively. The active transcutaneous spinal cord stimulation (tSCS) provides electrical impulses to the spinal cord, which could enhance the effects of the exoskeleton by stimulating nerve activity. This dual approach offers a promising new avenue to improve movement and independence for individuals with spinal cord injuries.

This trial will compare two approaches for assisting walking in individuals with spinal cord injuries (SCI). One group will receive Exoskeleton-Assisted Walking (EAW) combined with active Transcutaneous Spinal Cord Stimulation (tSCS), while the other group will receive EAW with sham tSCS. Studies have shown that using a robotic exoskeleton to assist individuals with SCI in walking can increase physical activity, potentially preventing other health issues related to inactivity. Research suggests that adding gentle electrical stimulation to the spine, known as tSCS, can enhance walking by enabling faster and farther movement. Participants who have tried this combination often require less assistance when walking, both during and after the treatment. Using both the exoskeleton and tSCS together shows promise for improving muscle and bone health in those with long-term SCI.¹²³⁶⁷