Robot glove aims to boost stroke recovery in landmark trial
NCT ID NCT06839482
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
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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
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
20 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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ASST Papa Giovanni XXIII
NOT_YET_RECRUITINGBergamo, 24127, Italy
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Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3
NOT_YET_RECRUITINGOlomouc, 77900, Czechia
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Centro Lescer, Occupational Therapy and Physical Therapy Department
NOT_YET_RECRUITINGMadrid, 28050, Spain
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Charles University and General University Hospital in Prague
NOT_YET_RECRUITINGPrague, Czechia
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Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences
NOT_YET_RECRUITINGChiang Mai, 50200, Thailand
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Department of Rehabilitative Medicine, AUSL Piacenza
NOT_YET_RECRUITINGFiorenzuola d'Arda, PC, 29017, Italy
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European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation
NOT_YET_RECRUITINGRome, Choose One..., Italy
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Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA
NOT_YET_RECRUITINGRome, RM, 00128, Italy
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IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory
NOT_YET_RECRUITINGMessina, 98123, Italy
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IRCCS Fondazione Don Gnocchi
ACTIVE_NOT_RECRUITINGFlorence, Italy
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IRCCS San Raffaele Roma
RECRUITINGRome, RM, 00163, Italy
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Istituto Clinico Tiberino
ENROLLING_BY_INVITATIONUmmbertide, PG, 06019, Italy
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Jefferson Moss-Magee Rehabilitation, Department of PMR
NOT_YET_RECRUITINGElkins Park, Pennsylvania, 19027, United States
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Lázně Bělohrad a.s., Centrum komplexní rehabilitace
NOT_YET_RECRUITINGLázně Bělohrad, 50781, Czechia
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Medical Centre for Rehabilitation Treatment "Consilium"
NOT_YET_RECRUITINGMoscow, 141052, Russia
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Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1
NOT_YET_RECRUITINGPassignano sul Trasimeno, Perugia, 06065, Italy
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Rehabilitation Center of Kladruby
NOT_YET_RECRUITINGKladruby, 257 62, Czechia
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Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section
NOT_YET_RECRUITINGFoggia, 7100, Italy
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San Vito Hospital, Rehabilitation Unit
NOT_YET_RECRUITINGSan Vito sullo Ionio, CZ, 88067, Italy
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University of Catanzaro "Magna Graecia"
NOT_YET_RECRUITINGCatanzaro, Italy
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Valduce Hospital, Villa Beretta Rehabilitation Center
NOT_YET_RECRUITINGCosta Masnaga, LC, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Can a nurse and a neighbor help tame chronic disease?
- Can PET scans reveal hidden heart inflammation after a stroke?
- Two ways to catch a hidden heart rhythm after stroke