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
IRCCS San Raffaele Roma
130 participants
Feb 6, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 Criteria9
- 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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Interventions
The EG will follow a mixed rehabilitation approach for the upper limb, combining Robotic Assisted Upper Limb Rehabilitation and conventional physical therapy (PT) and/or occupational therapy (OT) with a total daily duration of 90 minutes. The Robotic Assisted UL Rehabilitation's session will last 30 minutes, with the following procedure provided: * First week: alternate between passive mobilization exercises, bilateral mode, and therapist-driven mode. * Second week: alternate between therapist-driven mode and active-assisted mobilization. * Third week: alternate between active-assisted mobilization and active mobilization. * Fourth week: alternate between active-assisted mobilization and active mobilization. * Fifth week: exclusively perform active mobilization. However, if this proposed progression does not match the patient's motor capabilities, the therapist will optimize the therapeutic program by selecting personalized exercises, following a progressive difficulty approach.
The CG will follow a conventional occupational therapy (OT) and physical therapy (PT) program for upper limb rehabilitation, with a total daily duration of 90 minutes. Upper limb rehabilitation exercises will be performed with a therapist who will tailor the treatment according to the patient's clinical characteristics and needs. Specifically, upper limb treatment will consist of motor exercises (shoulder, elbow, wrist, and hand) through a mix of individual sessions with both passive and active interventions where possible.
Locations(21)
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NCT06839482