Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Sponsored by IRCCS San Raffaele Roma
About this study
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.
Stroke is a leading cause of disability worldwide, with hemiparesis impairing upper limb function in 75% of affected patients. This deficit significantly reduces patients' independence in activities of daily living (ADLs) and limits social participation. Recovery of upper limb motor function is a primary goal in post-stroke rehabilitation. In recent years, robotic devices for hand rehabilitation have been introduced. The Gloreha Sinfonia® (R-Touch Pro, BTL Robotics) is a robotic exoskeleton that enables repetitive, intensive movements in passive, assisted, and active modes. Despite growing evidence supporting robotics in upper limb rehabilitation, significant gaps remain, including the lack of standardized protocols and the challenge of identifying patient subgroups that would benefit most…
Where this study is enrolling
- I'm interested
Jefferson Moss-Magee Rehabilitation, Department of PMR
Elkins Park, Pennsylvania
Who can participate
Inclusion criteria
- ✓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 criteria
- ✕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
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Trial data sourced from ClinicalTrials.gov.