The Effect of Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation on Bone Strength.

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Bronx VA Medical Center
Study ID
NCT07325149
Status
Not Yet Recruiting

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Conditions

  • Sarcopenia
  • Secondary Osteoporosis

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) — DEVICE
    The 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) — DEVICE
    The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2031
Completion
Jun 1, 2033

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)
    The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
  • Sham Comparator: Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)
    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).

Primary Outcome Measure

Muscle cross sectional area of the mid-thigh [ Time Frame: Obtained prior to starting the study at enrollment (baseline) and again after 9 months of participating in the study interventions. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Gail F Forrest, Ph.D.
[email protected]
609-558-2929
Steven C Kirshblum, M.D.
[email protected]
973-634-7079
Gail F Forrest, PhD (PRINCIPAL_INVESTIGATOR)
Christopher M Cirnigliaro, Ph.D. (PRINCIPAL_INVESTIGATOR)
Christopher P Cardozo, Ph.D. (SUB_INVESTIGATOR)
Noam Y Harel, M.D. (SUB_INVESTIGATOR)

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By research site
Kessler Foundation· West Orange, NJ

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