Robotic suits and spinal zaps help paralyzed veterans take steps
NCT ID NCT04241250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study tested two ways to stimulate the spinal cord—one with a surgically implanted device and one with surface electrodes—combined with a robotic exoskeleton to help people with spinal cord injury walk. Four men with complete paralysis below the chest took part. The goal was to see if these methods could improve walking speed and muscle activity, and possibly reduce other health problems linked to inactivity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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4 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Dec 2024
- 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 70 years
- Sex
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Male participants only
- 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: * All participants will be between 18-70 years old, male, 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 * 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: Participants with any of the following pre-existing medical conditions will be excluded from the current trial: * Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia * Unhealed fracture in either lower or upper extremities * Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees * 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 * 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 * Unable to fit in the device for any reason * Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons * Implanted pacemakers and/or implanted defibrillator devices * 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 * 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 recommendations * Untreatable severe spasticity judged to be contraindicated by the site Physician * Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more * Psychopathology documentation in the medical record or history that may conflict with study objectives * 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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Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Spinal implant aims to restore bladder control after paralysis
- Scientists map the daily rhythms of chronic pain
- Can AI learn to tune spinal cord stimulators?
- Which bowel care tool wins the race? trial pits suppository, enema, and irrigation device
- Robotic exoskeletons go home: can daily wear change life after spinal cord injury?