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Robot suit could revolutionize walking recovery for spinal cord patients

NCT ID NCT07036107

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a wearable robotic exoskeleton helps people with recent spinal cord injury regain walking ability better than standard physical therapy. Eighty participants will be randomly assigned to either robot-assisted or conventional gait training for 8 weeks. Researchers will also measure if the robot reduces caregiver burden and healthcare costs.

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 80 people

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

Started

Jan 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

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: * diagnosis of spinal cord injury (SCI) in the acute or subacute phase (\< 6 months of evolution) * traumatic or non-traumatic aetiology * neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B. * sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale). * range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position) * muscle spasticity in the lower extremities with a score ≤ 3 on the Modified Ashworth Scale (MAS) * tolerate bipedalism (having stood up in the last year) * aged between 18 and 70 years, with height between 150 cm and 190 cm, and weight less than 100 kg Exclusion Criteria: * WISCI ≥ 15 * cognitive or neurological limitations that prevent following instructions * another neurologic disorder permanently affecting gait and gait therapy (other than SCI) * grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton * unresolved fractures at the time of the study * uncontrolled autonomic dysautonomia * intolerance to exercise * uncontrolled epilepsy * previous experience with Robotic-Assisted Gait Training (RAGT). * ROM restriction such as flexing or arthrodesis will be excluded * spinal instability (or spinal orthotics unless cleared by a medical doctor). * deterioration \>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.

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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

    2 sites. 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

  • Hospital Nacional de Parapléjicos

    NOT_YET_RECRUITING

    Toledo, Castille-La Mancha, 45071, Spain

  • Hospital Universitario de Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

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