Robotic Rehabilitation of the Upper Limb in Subacute Stroke

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIRCCS San Raffaele Roma

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)

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators