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.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological assessment examination to determine the level and completeness of SCI when participants screen for entry into the study. The ISNCSCI exam will be performed by the study physician using a tool that assesses sensory function (light touch and pinprick) in each dermatome (A dermatome is an area of skin that sends touch, pain, temperature, and other sensory signals back to the brain) and motor function (motor function is a general term to describe the way muscles create movement) in ten key muscles. This test will determine the level of SCI, defined as the lowest spinal level with normal function, and assigns a classification of severity according to the ISNCSCI scale. In this study, both ISNCSCI grade C and grade D would make a participant eligible for this study.
DXA study to assess bone mineral density (BMD) at the total hip (TH), distal femur (DF), and proximal tibia (PT) that will be compared to the cutoff values described in the
Medical history and exam to ensure medical health, anthropometric compatibility for EAW, and to identify fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs.
Between the ages of 21-60 years old
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.
Parallel
Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)
DeviceThe full electrical signal is delivered during lumbosacaral tSCS treatment while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + active tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).
Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)
DeviceThe lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.
Muscle cross sectional area of the mid-thigh
EAW + active tSCS will increase muscle cross sectional area of the mid-thigh more than EAW + sham tSCS.
Bone Strength at the Distal Femur and Proximal Tibia
EAW + active tSCS will increase bone strength at the distal femur and proximal tibia more than EAW + sham tSCS.
Muscle and Bone Serum and Plasma Biomarker Time-Course Response
An intravenous line will be placed to draw serial serum and plasma samples prior to (time 0), and again 30, 60, 120, 180, minutes and 24, and 48 hours following an acute session of either an EAW + sham tSCS or an EAW + active tSCS training intervention depending on that participant's group assignment.
Seated and Supine Electromyography (EMG) assessments of Muscle Activation
Surface EMG data will be collected from muscles in each leg to assess surface EMG amplitudes of these muscles during attempts at volitional knee extension and flexion and ankle plantar- and dorsi-flexion using surface sensors. Furthermore, the resting EMG protocol will be performed to determine the individualized mapping to determine the minimum tSCS intensity required to evoke a motor evoked potential (MEP).
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Bronx VA Medical Center
Lead sponsor
Kessler Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
