Robot suit and spinal zaps help paralyzed veterans take steps again
NCT ID NCT04782947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a combination of a wearable robot suit, electrical spinal stimulation, and muscle-strengthening exercises can help people with complete spinal cord injury walk on their own. Twenty adults with paralysis from the chest down will train for months to see if they can improve walking speed, muscle quality, and overall health. The goal is to make this technology easier to use and available to more people.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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May 2026
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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18 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.
Inclusion Criteria: 1. All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam. 2. Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI. 3. All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included. Exclusion Criteria: 1. Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia; 2. Unhealed fracture in either lower or upper extremities; 3. Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees. 4. Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture; 5. Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection; 6. Unable to fit in the device for any reason; 7. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons; 8. Implanted pacemakers and/or implanted defibrillator devices; 9. DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores \< -3.5 and knee BMD scores of less than 0.6 g/cm2 68-71; 10. Functional upper and lower extremity ROM, strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded from the trial. This is based on the Ekso® manufacturer's recommendations72; 11. Untreatable severe spasticity judged to be contraindicated by the site Physician; 12. Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more; 13. Psychopathology documentation in the medical record or history that may conflict with study objectives; 14. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection.
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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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Hunter Holmes McGuire VA Medical Center
RECRUITINGRichmond, Virginia, 23249, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?