The goal of this clinical trial is to validate an artificial intelligence-based decision support system (AI-DSS) for robotic rehabilitation in participants with stroke.
The study aims to answer the following questions:
* Can the AI-DSS support therapists in setting therapy parameters and adapting personalized robotic rehabilitation programs effectively? * Can AI-supported robotic rehabilitation improve upper limb function, activities of daily living (ADL), cognitive function, and quality of life compared with standard therapist-guided robotic rehabilitation?
Researchers will compare two groups:
* Robotic rehabilitation supported by the AI-DSS (CO-AIDER); * Robotic rehabilitation with parameters set by therapists (control group).
Participants will:
* Receive robotic rehabilitation for the upper limb, either guided by the AI-DSS or by therapists; * Be monitored throughout the program, with therapy parameters adjusted according to their progress; * Complete assessments to evaluate changes in upper limb function, activities of daily living, cognitive function, and quality of life.
The study will also evaluate the usability and acceptability of the AI-supported robotic system as perceived by participants and clinical staff, and will include a cost-effectiveness analysis of the two interventions.
Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);
Age between 18 and 85 years;
Time since stroke less than six months;
Mild to severe upper limb impairment (Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 58).
Behavioral or cognitive disorders and/or reduced compliance;
Severe spasticity or hypertonia in the affected limb (Modified Ashworth Scale (MAS) > 3);
Severe visual impairments;
Concurrent participation in another clinical trial for upper limb rehabilitation following stroke;
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborator
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborator