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Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

RecruitingNAAges 18 Years - anyAllUniversity of Florence
NCT06884553 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The functional recovery of the upper limb represents a critical element in post-stroke rehabilitation; hemiplegic/hemiparetic patients who achieve optimal recovery are a minority, and incomplete recovery has relevant consequences both on functioning and on quality of life of those who survive a stroke. The project aims to assess the effects on the functional recovery, with manual dexterity as the primary outcome, of a treatment protocol using an innovative tool (Gloreha Sinfonia) that enables assisted execution of three-dimensional tasks combined with Serious Games for cognitive stimulation, targeting the functional recovery of the upper limb in patients with stroke outcomes at least 6 months after the acute event (chronic phase). Patients with residual dysfunction of the upper limb, at least 6 months after the stroke, will be randomly assigned to the Robotic Rehabilitation group (ROBOT)

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. First ischemic or hemorrhagic stroke occurring at least 6 months prior. 2. Persistent motor deficit in the affected upper limb (Motricity Index between 18 and 77). 3. Willingness to participate in the study, with the provision of informed consent. Exclusion Criteria: 1. Severe spastic hypertonia at the wrist and fingers (Modified Ashworth Scale equal to or greater than 3). 2. Orthopedic, rheumatological, and/or peripheral nervous system disorders affecting the paretic upper limb. 3. Neurodegenerative and neuromuscular disorders. 4. Acute pathologies affecting other body systems. 5. Severe cognitive, language, and behavioral disorders that significantly limit understanding and participation in the planned activities.
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What it tests

  • Robotic therapy (Gloreha Sinfonia system)
  • Occupational therapy
  • Control
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Where

1 site
Fondazione Don Carlo Gnocchi Onlus
Florence, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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