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Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Sponsor: IRCCS San Raffaele Roma
Summary
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.
Official title: Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-02-06
Completion Date
2028-01-31
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Robotic Assisted Upper Limb Rehabilitation
The EG will follow a mixed rehabilitation approach for the upper limb, combining Robotic Assisted Upper Limb Rehabilitation and conventional physical therapy (PT) and/or occupational therapy (OT) with a total daily duration of 90 minutes. The Robotic Assisted UL Rehabilitation's session will last 30 minutes, with the following procedure provided: * First week: alternate between passive mobilization exercises, bilateral mode, and therapist-driven mode. * Second week: alternate between therapist-driven mode and active-assisted mobilization. * Third week: alternate between active-assisted mobilization and active mobilization. * Fourth week: alternate between active-assisted mobilization and active mobilization. * Fifth week: exclusively perform active mobilization. However, if this proposed progression does not match the patient's motor capabilities, the therapist will optimize the therapeutic program by selecting personalized exercises, following a progressive difficulty approach.
Control Group (CG)
The CG will follow a conventional occupational therapy (OT) and physical therapy (PT) program for upper limb rehabilitation, with a total daily duration of 90 minutes. Upper limb rehabilitation exercises will be performed with a therapist who will tailor the treatment according to the patient's clinical characteristics and needs. Specifically, upper limb treatment will consist of motor exercises (shoulder, elbow, wrist, and hand) through a mix of individual sessions with both passive and active interventions where possible.
Locations (20)
Jefferson Moss-Magee Rehabilitation, Department of PMR
Elkins Park, Pennsylvania, United States
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
Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA
Rome, RM, Italy
IRCCS San Raffaele Roma
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
Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences
Chiang Mai, Thailand