About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Robotic Assisted Upper Limb Rehabilitation
- Control Group (CG)