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Can a robotic suit plus spinal stimulation help paralyzed individuals walk again?

NCT ID NCT07745686

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1005, Switzerland

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Other studies related to the condition(s) this trial covers.