About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs
Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)
As determined by the study physician from the screening DXA study, a T-score at the total hip < -3.5 or aBMD of the knee (proximal tibia and/or distal femur) < 0.60 g/cm2 from the DXA screen
Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation
Trial design
Treatments tested in this trial
- Exoskeleton-Assisted Walking (EAW)
- Sham Transcutaneous Spinal Cord Stimulation (tSCS)
- Active Transcutaneous Spinal Cord Stimulation (tSCS)