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Robots vs. therapists: a head-to-head trial for stroke recovery

NCT ID NCT06547827

Disease control Sponsor: Fondazione Don Carlo Gnocchi ETS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This large trial compares robot-assisted rehabilitation to traditional one-on-one physiotherapy for people who have had a stroke. Researchers are measuring how well each approach helps patients regain independence in daily activities, as well as costs and patient satisfaction. The goal is to determine whether high-tech rehab tools offer real advantages over standard care.

What this could mean

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

Active substance
robot-assisted rehabilitation compared to traditional one-on-one physiotherapy
What this could lead to
If robot-assisted rehab proves more effective or cost-efficient, it could become a standard option for stroke recovery, potentially improving outcomes for many patients.
What could go wrong
This is a pragmatic trial, not a blinded one, so results may be influenced by patient or therapist expectations. The robot approach also requires specialized equipment and training, which may limit adoption.

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 596 people

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

Started

Aug 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 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: * First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging; * Age 18 years and over; * Time since the event equal to or less than 6 months; * Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45); * Clinical stability allowing transfer to the gym and execution of the planned treatments. Exclusion Criteria: * Clinical instability; * Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \<10); * Rigidity or hypertonia (Modified Ashworth Scale \> 3) in the plegic/paretic limb; * Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices; * Pregnant women; * Refusal to sign the informed consent.

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

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

Stroke

How to take part

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

  1. The places running it

    27 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

  • APSS Trento

    RECRUITING

    Trento, Italy

  • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

    RECRUITING

    Catania, Italy

  • Azienda Sanitaria dell'Alto Adige - Ospedale di Vipiteno

    RECRUITING

    Sterzing, Italy

  • Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

    RECRUITING

    Bergamo, Italy

  • Fondazione Don Carlo Gnocchi, Centro Gala

    RECRUITING

    Acerenza, Italy

  • Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare

    RECRUITING

    Salerno, Italy

  • Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

    RECRUITING

    Roma, Italy

  • Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente

    RECRUITING

    Milan, Italy

  • Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

    RECRUITING

    Sant'Angelo dei Lombardi, Italy

  • Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo

    RECRUITING

    Tricarico, Italy

  • IRCCS Centro Neurolesi "Bonino Pulejo"

    RECRUITING

    Messina, Italy

  • IRCCS Fondazione Mondino

    RECRUITING

    Pavia, Italy

  • IRCCS Istituti Clinici Scientifici Maugeri

    RECRUITING

    Bari, Italy

  • IRCCS Istituti Clinici Scientifici Maugeri

    RECRUITING

    Milan, Italy

  • IRCCS Istituti Clinici Scientifici Maugeri

    RECRUITING

    Montescano, Italy

  • IRCCS Istituti Clinici Scientifici Maugeri

    RECRUITING

    Pavia, Italy

  • IRCCS Istituti Clinici Scientifici Maugeri

    RECRUITING

    Telese Terme, Italy

  • IRCCS Ospedale Policlinico San Martino,

    RECRUITING

    Genova, Italy

  • IRCCS San Raffaele Roma s.r.l.

    RECRUITING

    Roma, Italy

  • Istituto S. Anna di Ezio Pugliese s.r.l.

    RECRUITING

    Crotone, Italy

  • San Camillo IRCCS s.r.l.

    RECRUITING

    Venezia, Italy

  • Università Humanitas University - Hunimed (IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.)

    RECRUITING

    Rozzano, Italy

  • Università degli Studi Magna Graecia di Catanzaro (A.O.U. "Renato Dulbecco" Catanzaro)

    RECRUITING

    Catanzaro, Italy

  • Università degli Studi di Padova (Azienda Ospedale Università di Padova)

    RECRUITING

    Padova, Italy

  • Università degli Studi di Salerno (Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona)

    RECRUITING

    Salerno, Italy

  • Università di Foggia (Azienda Ospedaliero-Universitaria "Policlinico Riuniti" - Foggia)

    RECRUITING

    Foggia, Italy

  • Università di Pisa (A.O.U. Pisana)

    RECRUITING

    Pisa, Italy

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