Robotic Arm Exoskeleton Therapy for Upper Limb Recovery After Stroke
Tests a robotic exoskeleton added to usual therapy in adults with recent stroke.
Plain-language title generated from the registry record
Registry title: Robotic Rehabilitation of the Upper Limb in Subacute Stroke
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06839482, who can take part
Where in Spain
- Centro Lescer, Occupational Therapy and Physical Therapy DepartmentMadrid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele Roma
- Trial code
- NCT06839482
- Record updated
- 23 April 2026
- Original description
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).Read full original descriptionShow less
Efficacy of Robotic Rehabilitation for Neuro Recovery of the Upper Limb in Subacute Stroke Survivors: An International Multicenter Randomized Controlled 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.
Inclusion: 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: 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; Open wounds, infections, or unprotected skin lesions on the upper limb; Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period; 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.