Robotic Rehabilitation of the Upper Limb in Subacute Stroke

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT06839482

Run by

IRCCS San Raffaele Roma

People needed

130

Starts

2025-02-06

Expected to finish

2028-01-31

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• IRCCS San Raffaele Roma — Rome, RM, Italy (enrolling)
• Rehabilitation Center of Kladruby — Kladruby, Czechia
• Lázně Bělohrad a.s., Centrum komplexní rehabilitace — Lázně Bělohrad, Czechia
• Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3 — Olomouc, Czechia
• Charles University and General University Hospital in Prague — Prague, Czechia
• European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation — Rome, Choose One..., Italy
• San Vito Hospital, Rehabilitation Unit — San Vito sullo Ionio, CZ, Italy
• Valduce Hospital, Villa Beretta Rehabilitation Center — Costa Masnaga, LC, Italy
• Department of Rehabilitative Medicine, AUSL Piacenza — Fiorenzuola d'Arda, PC, Italy
• Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1 — Passignano sul Trasimeno, Perugia, Italy
• Istituto Clinico Tiberino — Ummbertide, PG, Italy
• Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA — Rome, RM, Italy
• ASST Papa Giovanni XXIII — Bergamo, Italy
• University of Catanzaro "Magna Graecia" — Catanzaro, Italy
• IRCCS Fondazione Don Gnocchi — Florence, Italy
• Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section — Foggia, Italy
• IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory — Messina, Italy
• Medical Centre for Rehabilitation Treatment "Consilium" — Moscow, Russia
• Centro Lescer, Occupational Therapy and Physical Therapy Department — Madrid, Spain
• Jefferson Moss-Magee Rehabilitation, Department of PMR — Elkins Park, Pennsylvania, United States
• Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences — Chiang Mai, Thailand

Full record on ClinicalTrials.gov

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