Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength
VA Office of Research and Development
Summary
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.
Description
Background: Immobilization results in bone loss that predisposes to osteoporosis and fracture, which may be complicated by non-union, infection, and deep venous thrombosis. Reduced muscular contraction after SCI and the elevated release of cortisol contribute to a catabolic state, resulting in a loss of lean tissue mass (LTM) below the level of lesion. Six months after motor-complete SCI, the average muscle cross-sectional area (CSA) significantly decreases at the quadriceps, hamstrings, and hip adductors (14-16%), and 12% and 24% at the soleus and gastrocnemius, respectively. Following SCI, t…
Eligibility
- Age range
- 21–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Non-walkers with an SCI greater than 3 years post injury * As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D * Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening) * Capable of gripping Lofstrand crutches and/or a walker without assistance * Wheelchair reliant 100% of the time * Height is between 62 inches and 74 inches * Weight less than 220lbs * Anthropometric compatibility with the EAW devi…
Interventions
- DeviceExoskeleton-Assisted Walking (EAW)
Participants will perform EAW will for 60 minutes per session for a total of 108 sessions (3 X week for 36 weeks).
- DeviceSham Transcutaneous Spinal Cord Stimulation (tSCS)
The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.
- DeviceActive Transcutaneous Spinal Cord Stimulation (tSCS)
Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
Locations (2)
- Kessler FoundationWest Orange, New Jersey
- James J. Peters VA Medical Center, Bronx, NYThe Bronx, New York