Robotic suit aims to get spinal injury patients back on their feet
NCT ID NCT07461259
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a robotic exoskeleton called TWIICE Rise to see if it is safe and practical for people with spinal cord injury to use for walking. The trial involves 15 participants and will take place in clinics, homes, and community settings. The goal is to assess how well the device works and if any problems arise, not yet to prove it improves health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TWIICE Rise robotic exoskeleton
- What this could lead to
- If successful, this could show that the TWIICE Rise exoskeleton is a safe and practical way for people with spinal cord injury to walk in daily life.
- What could go wrong
- This is a very small, early pilot study with only 15 people. It focuses on safety and feasibility, not on proving health benefits. The device may not work for everyone or may have technical issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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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. Informed Consent signed by the subject. 2. Traumatic and non-traumatic SCI 3. Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI. 4. Male and non-pregnant, non-lactating female aged 18 to 70 years old 5. At least 6 months after injury 6. Able to stand or maintain upright position with a standing device (e.g., 'Easy stand') for at least ten minutes without clinical symptoms of orthostatic hypotension. 7. Able to use crutches. 8. Able to sit with knees and hips \>= 90° flexion 9. Phase 1: Height of 160 to 180 cm, Phase 2: Height of 160 to 190 cm 10. Phase 1: Weight of \<80 kg, Phase 2: Weight of \<100 kg Exclusion Criteria: 1. History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke) 2. Ability to walk 10 meters without physical assistance of a person 3. Severe concurrent medical disease, illness, or condition 4. Systemic or peripheral infection influencing wearing an exoskeleton. 5. Diagnosis of coronary artery disease that precludes moderate to intense exercise. 6. A medical diagnosis in the patient chart of atherosclerosis, congestive heart failure, or history of myocardial infarction 7. Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events. 8. Deep vein thromboses in lower extremities of less than 6 months duration. 9. Untreated sever hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>120 mmHg) 10. Unstable spine or unhealed limbs 11. History of lower extremities or pelvic fragility fractures within the last two years 12. Heterotopic ossification that impairs joint mobility 13. Significant contractures defined as flexion contracture limited to 20 the hip and knee. 14. Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus 15. Diagnosis of severe osteoporosis/penia: Dual Energy X-ray Absorptiometry (DXA) results indicating a t-score below -3.5 at the femoral neck or the total proximal femur bone, and knee bone mineral density (BMD) \< 0.60 gm/cm2 16. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities 17. Psychiatric or cognitive conditions that may interfere with the trial. 18. Pregnancy or women who plan to become pregnant during the study period, and lactating women. 19. Patient is currently involved in any other interventional study. 20. Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary.
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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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Swiss Paraplegic Centre Nottwil
RECRUITINGNottwil, Canton of Lucerne, 6207, Switzerland
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Other studies related to the condition(s) this trial covers.
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- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?