NCT06839482 Robotic Rehabilitation of the Upper Limb in Subacute Stroke
| NCT ID | NCT06839482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2025-02-06 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Sanaz Pournajaf, DPT, PhD
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele Roma
Frequently Asked Questions
Who can join the NCT06839482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839482 currently recruiting?
Yes, NCT06839482 is actively recruiting participants. Contact the research team at sanaz.pournajfa@sanraffaele.it for enrollment information.
Where is the NCT06839482 trial being conducted?
This trial is being conducted at Elkins Park, United States, Kladruby, Czechia, Lázně Bělohrad, Czechia, Olomouc, Czechia and 11 additional locations.
Who is sponsoring the NCT06839482 clinical trial?
NCT06839482 is sponsored by IRCCS San Raffaele Roma. The principal investigator is Sanaz Pournajaf, DPT, PhD at IRCCS San Raffaele Roma. The trial plans to enroll 130 participants.
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