Exoskeleton-Assisted Walking + Spinal Cord Stimulation for Bone Loss in Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
Immobilization following spinal cord injury (SCI) results in muscle and bone loss below the level of injury, which ultimately predisposes to fracture at several sites throughout the legs and can lead to several medical complications that can devastate quality of life. There is a scarcity of research that has successfully implemented rehabilitation and/or exercise training interventions to preserve the musculoskeletal system during the acute phase SCI, or possibly reverse the muscle and bone loss that has already occurred in chronic SCI. This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) (EAW + active tSCS), to that of EAW + sham tSCS, on measures of muscle and bone health in a cohort of chronically injured motor incomplete SCI. A successful outcome would expand treatment options to improve musculoskeletal health over the lifetime.
Who Is on the Research Team?
Christopher P Cardozo, M.D.
Principal Investigator
James J. Peters VA Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with chronic spinal cord injury who have experienced muscle and bone loss. Participants should be in a stable condition to undergo exoskeleton-assisted walking training. Those with certain medical conditions that could interfere with the study or pose a risk during physical activity are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive exoskeleton-assisted walking (EAW) training combined with either active or sham transcutaneous spinal cord stimulation (tSCS) for 108 sessions over 36 weeks
Midpoint Assessment
Imaging and EMG assessments are conducted to evaluate muscle and bone health after approximately 54 training sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation
Trial Overview
The study tests if adding transcutaneous spinal cord stimulation (tSCS) to exoskeleton-assisted walking (EAW) improves muscle and bone health more than EAW alone. Participants will be randomly assigned to receive either active tSCS or sham (inactive) treatment alongside EAW.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
The EAW + sham tSCS group will receive simultaneous lumbosacral sham tSCS while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + sham tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bronx VA Medical Center
Lead Sponsor
Kessler Foundation
Collaborator
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