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Robot glove aims to boost stroke recovery in landmark trial

NCT ID NCT06839482

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This international study tests whether a robotic exoskeleton (Gloreha Sinfonia) combined with standard therapy can improve arm function in people who recently had a stroke. 130 participants will be randomly assigned to either robotic therapy plus standard care or standard care alone. The main goal is to see if the robotic device leads to better voluntary movement and coordination.

What this could mean

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

Active substance
Robotic exoskeleton (Gloreha Sinfonia) for upper limb rehabilitation
What this could lead to
If it works, this could point toward a more effective way to regain arm function after a stroke, potentially improving independence and quality of life.
What could go wrong
This is a mid-stage trial with 130 people, so results may not apply to everyone. The robotic device may not provide a meaningful advantage over standard therapy, and some participants may find it uncomfortable or inconvenient.

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 130 people

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

Started

Feb 2025

Expected to finish

Jan 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 to 85 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: * Both sexes * Age 18-90 years * Paresis of the upper limb following a recent cerebrovascular event (subacute ischemic or hemorrhagic stroke) * Moderate to mild muscle weakness in the thumb opponens, common finger flexors, and wrist flexors, assessed with complete joint movement in absence of gravity, Medical Research Council Scale (MRC) ≥ 2 * Time from acute event \<90 days * Ability to understand and sign the study informed consent * Ability to perform study procedures. Exclusion Criteria: * Presence of other overlapping neurological disorders * Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility * Severe psychiatric disorders * Severe cognitive (MMSE ≤ 17) and/or language impairment compromising exercise comprehension * Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period * Open wounds, infections, or unprotected skin lesions on the upper limb * Severe spasticity of the upper limb (biceps and wrist and finger flexors) (MAS \> 3) * Inability to adhere to the exercise program due to low compliance * Participants who have not signed the informed consent for the study

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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

    20 sites in 6 countries. 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

  • ASST Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3

    NOT_YET_RECRUITING

    Olomouc, 77900, Czechia

  • Centro Lescer, Occupational Therapy and Physical Therapy Department

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • Charles University and General University Hospital in Prague

    NOT_YET_RECRUITING

    Prague, Czechia

  • Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences

    NOT_YET_RECRUITING

    Chiang Mai, 50200, Thailand

  • Department of Rehabilitative Medicine, AUSL Piacenza

    NOT_YET_RECRUITING

    Fiorenzuola d'Arda, PC, 29017, Italy

  • European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation

    NOT_YET_RECRUITING

    Rome, Choose One..., Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA

    NOT_YET_RECRUITING

    Rome, RM, 00128, Italy

  • IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory

    NOT_YET_RECRUITING

    Messina, 98123, Italy

  • IRCCS Fondazione Don Gnocchi

    ACTIVE_NOT_RECRUITING

    Florence, Italy

  • IRCCS San Raffaele Roma

    RECRUITING

    Rome, RM, 00163, Italy

  • Istituto Clinico Tiberino

    ENROLLING_BY_INVITATION

    Ummbertide, PG, 06019, Italy

  • Jefferson Moss-Magee Rehabilitation, Department of PMR

    NOT_YET_RECRUITING

    Elkins Park, Pennsylvania, 19027, United States

  • Lázně Bělohrad a.s., Centrum komplexní rehabilitace

    NOT_YET_RECRUITING

    Lázně Bělohrad, 50781, Czechia

  • Medical Centre for Rehabilitation Treatment "Consilium"

    NOT_YET_RECRUITING

    Moscow, 141052, Russia

  • Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1

    NOT_YET_RECRUITING

    Passignano sul Trasimeno, Perugia, 06065, Italy

  • Rehabilitation Center of Kladruby

    NOT_YET_RECRUITING

    Kladruby, 257 62, Czechia

  • Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section

    NOT_YET_RECRUITING

    Foggia, 7100, Italy

  • San Vito Hospital, Rehabilitation Unit

    NOT_YET_RECRUITING

    San Vito sullo Ionio, CZ, 88067, Italy

  • University of Catanzaro "Magna Graecia"

    NOT_YET_RECRUITING

    Catanzaro, Italy

  • Valduce Hospital, Villa Beretta Rehabilitation Center

    NOT_YET_RECRUITING

    Costa Masnaga, LC, Italy

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