Looking for volunteers
Robotic Rehabilitation of the Upper Limb in Subacute Stroke
NCT06839482 · IRCCS San Raffaele Roma · Updated 23 April 2026
- What is being tested
- Robotic Assisted Upper Limb Rehabilitation; Control Group (CG)
- For
- Stroke
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 85 years. About 130 people. The full rules are on the registry page.
- Where
- United States, Czechia, Italy, Russia, Spain, Thailand (21 sites)
- When
- Starts or started 6 Feb 2025, ends 31 Jan 2028. Registered 21 Feb 2025.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Jefferson Moss-Magee Rehabilitation, Department of PMRElkins Park, Pennsylvania, United States
- Rehabilitation Center of KladrubyKladruby, Czechia
- Lázně Bělohrad a.s., Centrum komplexní rehabilitaceLázně Bělohrad, Czechia
- Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3Olomouc, Czechia
- Charles University and General University Hospital in PraguePrague, Czechia
- European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in RehabilitationRome, Choose One..., Italy
- San Vito Hospital, Rehabilitation UnitSan Vito sullo Ionio, CZ, Italy
- Valduce Hospital, Villa Beretta Rehabilitation CenterCosta Masnaga, LC, Italy
- Department of Rehabilitative Medicine, AUSL PiacenzaFiorenzuola d'Arda, PC, Italy
- Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1Passignano sul Trasimeno, Perugia, Italy
- Istituto Clinico TiberinoUmmbertide, PG, Italy
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESARome, RM, Italy
- IRCCS San Raffaele RomaRome, RM, Italy
- ASST Papa Giovanni XXIIIBergamo, Italy
- University of Catanzaro "Magna Graecia"Catanzaro, Italy
- IRCCS Fondazione Don GnocchiFlorence, Italy
- Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery SectionFoggia, Italy
- IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology LaboratoryMessina, Italy
- Medical Centre for Rehabilitation Treatment "Consilium"Moscow, Russia
- Centro Lescer, Occupational Therapy and Physical Therapy DepartmentMadrid, Spain
- Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical SciencesChiang Mai, Thailand