Robotic Arm Exoskeleton Therapy for Upper Limb Recovery After Stroke
Tests a robotic exoskeleton added to usual therapy in adults with recent stroke.
Plain-language title generated from the registry record
Registry title: Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Key facts
- Where
- Bergamo, Catanzaro, Costa Masnaga, Fiorenzuola d'Arda, Florence, Foggia, Messina, Passignano sul Trasimeno, Rome, San Vito sullo Ionio, and Ummbertide, ItalySee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06839482, who can take part
Where in Italy
- Asst Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- University of Catanzaro "Magna Graecia"Catanzaro, ItalyNot yet recruiting
- Valduce Hospital, Villa Beretta Rehabilitation CenterCosta Masnaga, ItalyNot yet recruiting
- Department of Rehabilitative Medicine, AUSL PiacenzaFiorenzuola d'Arda, ItalyNot yet recruiting
- IRCCS-Fondazione Don GnocchiFlorence, ItalyNo longer taking part
- Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery SectionFoggia, ItalyNot yet recruiting
- IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology LaboratoryMessina, ItalyNot yet recruiting
- Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1Passignano sul Trasimeno, ItalyNot yet recruiting
- European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in RehabilitationRome, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESARome, ItalyNot yet recruiting
- IRCCS San Raffaele RomaRome, ItalyTaking people
- San Vito Hospital, Rehabilitation UnitSan Vito sullo Ionio, ItalyNot yet recruiting
- Istituto Clinico TiberinoUmmbertide, ItalyEnrolling by invitation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele Roma
- Trial code
- NCT06839482
- Record updated
- 23 April 2026
- Original description
This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component).Read full original descriptionShow less
Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial
This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component).
Participants will be randomly assigned to one of two groups:
* Experimental Group (EG): Robotic-assisted upper limb rehabilitation combined with conventional therapy. * Control Group (CG): Conventional therapy alone including upper limb rehabilitation.
Clinical assessments will be conducted at baseline (T1), post-treatment (T2), and at a 3-month follow-up (T3) using remotely administered scales.
Secondary objectives include evaluating improvements in muscle strength, range of motion, eye-hand coordination, manual dexterity, and functional independence. The study will also assess prognostic factors influencing response to robotic therapy, patient satisfaction, and potential adverse events.
Inclusion: 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: 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; Open wounds, infections, or unprotected skin lesions on the upper limb; Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period; 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.