Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled Trial
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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
About the 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.
What is being tested
- Robotic Assisted Upper Limb Rehabilitation (device)
- Control Group (CG) (other)
Sponsor: IRCCS San Raffaele Roma · Participants: 130 · Started: Feb 6, 2025
Contact the study team
- Sanaz Pournajaf, DPT, PhD · Phone: +39 0652252405
- Carrie Louise Thouant, OT, MSc · Phone: +39 0652252338
Official record on ClinicalTrials.gov — NCT06839482
Locations in the U.S.
| Pennsylvania | Jefferson Moss-Magee Rehabilitation, Department of PMR, Elkins Park (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.