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NOT YET RECRUITING
NCT07418398
NA

Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-07-01

Completion Date

2032-07-01

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DEVICE

Exoskeleton-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).

DEVICE

Sham Transcutaneous Spinal Cord Stimulation (tSCS)

The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.

DEVICE

Active Transcutaneous Spinal Cord Stimulation (tSCS)

Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.

Locations (2)

Kessler Foundation

West Orange, New Jersey, United States

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States