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Can a robotic suit plus spinal stimulation help paralyzed individuals walk again?
NCT ID NCT07745686
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether combining a robotic exoskeleton with spinal cord stimulation can help people with chronic spinal cord injury walk more easily. The study will include a small group of adults who already have a spinal stimulator implanted and have completed prior rehabilitation trials. The main goal is to check the safety and feasibility of this combined approach, with the hope of guiding future rehabilitation tools that could be used in everyday settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Combination of the TWIICE Rise 1.0 robotic exoskeleton and epidural electrical stimulation (EES)
- What this could lead to
- If successful, this could lead to more practical, real-world rehabilitation tools that help people with spinal cord injury regain mobility and reduce dependence on lab-based equipment.
- What could go wrong
- This is a very early, small feasibility study focused on safety, not proof of effectiveness. The combination may not work as hoped, and there are risks of adverse events from the stimulation or exoskeleton.
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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- 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: * Currently enrolled participants who have completed the relevant phase of their parent study at CHUV: BoxSwitch (NCT05942339, after the optimisation phase), Think2Go (NCT06243952, after the rehabilitation phase, or STIMO-BSI (NCT04632290, after the calibration and training phase of the optional extension with system upgrade), * Must have a functional neuromodulation system, * Must be at least 18 years old, * Must be suffering from non-progressive traumatic spinal cord injury, sustained at least 12 months before signing the consent form, * Must weigh less than 100 kg, * Must have a standing height between 160 and 190 cm, * Must be able to grasp and lift bilateral crutches in a seated position, * Must have stable medical, physical and psychological condition as considered by the investigator, * Must be able to understand and interact with the study team in French or English, * Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments, * Must provide Informed Consent as documented by signature prior to any study-related procedures. Exclusion Criteria: * Must not be diagnosed with severe osteoporosis/penia: Dual Energy X-ray Absorptiometry (DEXA) results indicating a t-score below -3.5 at either the femoral neck or the total proximal femur. Dual Energy X-ray Absorptiometry (DEXA) results indicating a bone mineral density (BMD) \< 0.60 gm/cm2 at any knee region (distal femur, proximal tibia) * Must not have deep vein thrombosis in lower extremities within the past 6 months. * Must not have experienced lower extremity fractures within the last two years. * Must not have current pressure ulcer of the arms, trunk, pelvic area, or lower extremities * Must not present with a flexion contracture \>15° at the hip or knee * Must not have severe concurrent medical conditions that contraindicate moderate to intense exercise (e.g., uncontrolled hypertension, coronary artery disease, congestive heart failure). * Must not have heterotopic ossification that impairs joint mobility * Must not be implanted with a life-supporting medical device (devices implanted in the parent study are not considered life-supporting), * Must not be pregnant, * Must not be the investigator himself, his/her family members, employees, or other dependent persons.
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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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Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1005, Switzerland
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?