Robotic Rehabilitation Vs Occupational Therapy Chronic Stroke Upper Limb Rehabilitation

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 patients will be evaluated at baseline (T0), at a 5-week interval (T1), and 6 months after the end of treatment (T2). Outcome indicators include measures of manual dexterity/upper limb performance, anxiety/depression, cognitive abilities, and patient-perceived outcomes. The analysis of Surface Plasmon Resonance imaging (SPRi) of serum exosome content, detected at T0, T1, and T2, will be correlated with variations in functional measures to verify the hypothesis that induction of neuroplasticity underlies any observed changes. Short- and medium-term effects on functional, psychological outcomes, as well as indicators of neuroinflammation and neural regeneration from serum analysis using innovative SPRi, will be compared among the 3 groups.

NCT Number	NCT06884553
Lead Sponsor	University of Florence Collaborators: Fondazione Don Carlo Gnocchi ETS
Conditions	Chronic Stroke
Enrollment	72 participants
Start Date	2023-09-19
Primary Completion	2025-09-19 (estimated)
Study Completion	2025-09-19 (estimated)
Updated on ClinicalTrials.gov	2025-03-19