Actively Recruiting
Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Led by IRCCS San Raffaele Roma · Updated on 2026-04-23
130
Participants Needed
21
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, with complete joint movement in absence of gravity, Medical Research Council Scale 63 2
- Time from acute event less than 90 days
- Ability to understand and sign the study informed consent
- Ability to perform study procedures
You will not qualify if you...
- Presence of other overlapping neurological disorders
- Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility
- Severe psychiatric disorders
- Severe cognitive (MMSE 64 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
Jefferson Moss-Magee Rehabilitation, Department of PMR
Elkins Park, Pennsylvania, United States, 19027
Not Yet Recruiting
2
Rehabilitation Center of Kladruby
Kladruby, Czechia, 257 62
Not Yet Recruiting
3
Lázně Bělohrad a.s., Centrum komplexní rehabilitace
Lázně Bělohrad, Czechia, 50781
Not Yet Recruiting
4
Agel Hospital Prostějov, Rehabilitation Centre, Mathonova 1, Clinical Rehabilitation Centre FZV UP, Hněvotínská 3
Olomouc, Czechia, 77900
Not Yet Recruiting
5
Charles University and General University Hospital in Prague
Prague, Czechia
Not Yet Recruiting
6
European Society of Physical and Rehabilitation Medicine, SISC in New Technologies and Robotics in Rehabilitation
Rome, Choose One..., Italy
Not Yet Recruiting
7
San Vito Hospital, Rehabilitation Unit
San Vito sullo Ionio, CZ, Italy, 88067
Not Yet Recruiting
8
Valduce Hospital, Villa Beretta Rehabilitation Center
Costa Masnaga, LC, Italy
Not Yet Recruiting
9
Department of Rehabilitative Medicine, AUSL Piacenza
Fiorenzuola d'Arda, PC, Italy, 29017
Not Yet Recruiting
10
Passignano Hospital, Department of Specialized Medicine, Usl Umbria 1
Passignano sul Trasimeno, Perugia, Italy, 06065
Not Yet Recruiting
11
Istituto Clinico Tiberino
Ummbertide, PG, Italy, 06019
Enrolling by Invitation
12
Fondazione Policlinico Universitario Campus Bio-Medico di Roma, UOC di Medicina Fisica e Riabilitativa-CESA
Rome, RM, Italy, 00128
Not Yet Recruiting
13
IRCCS San Raffaele Roma
Rome, RM, Italy, 00163
Actively Recruiting
14
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
15
University of Catanzaro "Magna Graecia"
Catanzaro, Italy
Not Yet Recruiting
16
IRCCS Fondazione Don Gnocchi
Florence, Italy
Active, Not Recruiting
17
Riuniti Hospital, Neurorehabilitation, Spinal Cord Rehab. and Functional Recovery Section
Foggia, Italy, 7100
Not Yet Recruiting
18
IRCCS Centro Neurolesi Bonino-Pulejo, Innovation Technology Laboratory
Messina, Italy, 98123
Not Yet Recruiting
19
Medical Centre for Rehabilitation Treatment "Consilium"
Moscow, Russia, 141052
Not Yet Recruiting
20
Centro Lescer, Occupational Therapy and Physical Therapy Department
Madrid, Spain, 28050
Not Yet Recruiting
21
Chiang Mai University, Department of Occupational Therapy, Faculty of Associated Medical Sciences
Chiang Mai, Thailand, 50200
Not Yet Recruiting
Research Team
S
Sanaz Pournajaf, DPT, PhD
CONTACT
C
Carrie Louise Thouant, OT, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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