Exoskeletal-assisted Walking and Spinal Cord Stimulation for Bone Strength

This study is looking at how combining exoskeleton-assisted walking (EAW) with transcutaneous spinal cord stimulation (tSCS) affects bone and muscle health in people with long-term spinal cord injury (SCI). The study aims to see if this combination can help improve bone strength and muscle size, which are often lost after SCI. You could be eligible if you are between 21 and 60 years old and have a spinal cord injury. The study will compare participants who receive full tSCS with those who receive a very low, inactive (sham) tSCS, both while using an exoskeleton. The main way they will measure success is by looking at the muscle size in your mid-thigh after 9 months. The study plans to enroll 24 participants, but its current status is unclear.

Study design
This is an interventional study comparing two groups: one receiving active transcutaneous spinal cord stimulation (tSCS) and the other receiving sham tSCS, both combined with exoskeleton-assisted walking (EAW). It plans to enroll 24 participants.
What's involved
Participants will receive 60 minutes of exoskeleton-assisted walking (EAW) and transcutaneous spinal cord stimulation (tSCS) training per session, three times a week for 36 weeks, totaling 108 sessions. Muscle cross-sectional area will be measured at the start and after 9 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at enrollment (baseline) and again after 9 months of participating in the study interventions.

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NCT07325149

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

Not Yet Recruiting
NAAges 21–60InterventionalTreatment
Bronx VA Medical Center
~24 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Muscle cross sectional area of the mid-thigh
Measured over Obtained prior to starting the study at enrollment (baseline) and again after 9 months of participating in the study interventions.
Secondary Osteoporosis
Sarcopenia
1 sites across 1 states
New Jersey1
  • Christopher P Cardozo, M.D. · STUDY_DIRECTOR · James J. Peters VA Medical Center

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Eligibility criteria

Inclusion

Thigh length between 14 and 19 in (36 and 48 cm).
Shank length between 17 and 22 in (43 and 55 cm).

Exclusion

metal fragments or pieces in eyes or any other part of body
pacemakers or other implanted electrical devices
aneurysm clips (metal clips on wall of a large artery)
metallic prostheses (metal pins and heart valves)
internal hearing aids (cochlear implants)
permanent eyeliner
shrapnel fragments
piercing that cannot be removed
  • Muscle cross sectional area of the mid-thighObtained prior to starting the study at enrollment (baseline) and again after 9 months of participating in the study interventions.

    EAW + active tSCS will increase muscle cross sectional area of the mid-thigh more than EAW + sham tSCS.