Exoskeleton and spinal zaps may rebuild muscle and bone after paralysis
NCT ID NCT07325149
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether walking in a robotic exoskeleton combined with mild electrical stimulation of the spinal cord can improve muscle and bone health in people with chronic spinal cord injury. About 24 participants will be assigned to either active or sham stimulation during exoskeleton training. The goal is to see if the combination can reverse muscle and bone loss that often occurs after injury.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2033
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Participant Screening: 1. 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. 2. 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 exclusion criteria section. 3. 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. * Inclusion Criteria: 1. Between the ages of 21-60 years old 2. Non-walkers with an SCI greater than 3 years post injury. 3. 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. 4. Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening). 5. Capable of gripping Lofstrand crutches and/or a walker without assistance. 6. Wheelchair reliant 100% of the time. 7. Height is between 62 inches and 74 inches. 8. Weight less than 220lbs. 9. Anthropometric compatibility with the EAW device: * Thigh length between 14 and 19 in (36 and 48 cm). * Shank length between 17 and 22 in (43 and 55 cm). * Exclusion Criteria: 1. 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. 2. Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism) 3. 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 4. 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. 5. Currently in a gym/rehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff. 6. Currently prescribed any medications that can affect muscle and/or bone metabolism, as determined by the study staff. Exclusion Criteria from MRI Safety Screening: 1. Medically unsafe to receive an MRI scan. 2. Claustrophobia 3. Baclofen pump 4. Body metal, including any of the following: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kessler Foundation
West Orange, New Jersey, 07052, United States
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