Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Eligible age
18–85 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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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.
Sponsor: IRCCS San Raffaele Roma
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
Where it's recruiting
Elkins Park
Source: ClinicalTrials.gov · NCT06839482 · last updated 2026-04-23