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Robot-Assisted rehab could speed recovery for severe brain injury patients

NCT ID NCT06469983

Disease control Sponsor: Anna Estraneo Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special tilt-table with robotic leg movers (called Erigo) helps people with severe brain injuries recover better than traditional tilting. The table slowly brings patients upright while moving their legs, which may improve blood flow, muscle tone, and alertness. Researchers will compare cognitive and physical outcomes in 118 patients across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Erigo tilt-table with robotic leg stepper (with or without electrical stimulation)
What this could lead to
If it works, this could become a standard rehab tool to help severe brain injury patients regain upright mobility and cognitive function faster.
What could go wrong
This is a relatively small, early-stage trial (118 people) comparing two rehab approaches, so results may not apply to all patients. The device is not a treatment for the brain injury itself.

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 118 people

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

Started

Dec 2024

Expected to finish

Nov 2026

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 to 75 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: * Age between 18 and 75 years; * sABI due to traumatic, vascular, anoxic, or mixed etiology; * Stable behavioral/cognitive diagnosis on at least 4 behavioral evaluations in 1 week using the Italian version of the CRS-R in patients with pDoC, or the LCF-based cognitive assessment in patients with eDoC; * Time post-injury between 28 days and 6 months \[1\]; * Not recovered upright station; * Written informed consent by the patient's legal rep-resentative/primary caregiver. Exclusion Criteria: * Severe medical conditions hampering verticalization (e.g., severe hypotension or conditions realizing hemodynamic instability, end stage or severe symptomatic heart failure with reduced ejection fraction, cardiac arrhythmia of new diagnosis or arrhythmic flare, severe hepatic failure, chronic severe lower limb arterio-venous disease, sep-sis/septic shock, thrombus venous embolism of new diag-nosis, severe autonomic dysreflexia); * Severe medical conditions hampering lower limb mobili-zation (e.g., fractures, heterotopic ossifications); * Severe medical conditions impacting EEG activity (e.g., sub-continuous or abundant EEG epileptiform abnormali-ties); * Severe medical conditions influencing conscious-ness/cognitive status, such as severe hyponatremia or hy-poglycemia; * Contraindications to the use of Erigo®Basic and/or Eri-go®Pro (Hocoma, Volketswil, Switzerland) as per technical data sheet (see Appendix A); * Presence of prohibited drugs

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Conditions

The condition(s) this trial relates to.

brain injury Consciousness Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acquired brain injury Disorder of consciousness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 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

  • ICS Maugeri

    RECRUITING

    Pavia, 27100, Italy

  • IRCCS "S. Maria Nascente" - Fondazione Don Gnocchi

    RECRUITING

    Milan, Milan, 20148, Italy

  • IRCCS Maugeri Bari

    RECRUITING

    Bari, 70124, Italy

  • IRCCS Maugeri Telese Terme

    RECRUITING

    Telese Terme, BN, 82037, Italy

  • Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS

    RECRUITING

    Sant'Angelo dei Lombardi, Avellino, 83054, Italy

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