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Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

NCT06884553 · University of Florence · Updated 19 March 2025

What is being tested
Robotic therapy (Gloreha Sinfonia system); Occupational therapy; Control
For
Chronic Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 72 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 19 Sept 2023, ends 19 Sept 2025. Registered 19 March 2025.
Results
None posted yet.

In the researchers' words

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), the Occupational Therapy group (OT), focused on the use of the upper limb in functional tasks (task-oriented training), or the control group (CT - prescription of a home exercise program). Patients in the ROBOT and OT groups will undergo a total treatment period of 5 weeks, with 3 sessions per week lasting 1 hour, for a total of 15 sessions/hours of treatment. Patients assigned to the CT group will undergo an initial functional assessment required for defining the exercise program. All…
ClinicalTrials.gov, NCT06884553

Sites

  • Fondazione Don Carlo Gnocchi OnlusFlorence, Italy, Italy