Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
Trial ID: NCT07199322
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-09
Completion date: 2026-12
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Collaborators: Fondazione Policlinico Universitario Campus Bio-Medico; Scuola Superiore Sant'Anna di Pisa
Conditions: Stroke; Stroke Ischemic; Stroke Hemorrhagic; Upper Limb Rehabilitation
Interventions: Robotic upper limb rehabilitation in patients with Stroke with AI support; Robotic upper limb rehabilitation in patients with Stroke without AI support
Locations: Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo; Fondazione Don Carlo Gnocchi, Centro Spalenza; IRCSS Fondazione Don Carlo Gnocchi; Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo; Scuola Superiore Sant'Anna; Fondazione Don Carlo Gnocchi, Centro Gala; Fondazione Policlinico Universitario Campus Bio-Medico; Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza; Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligure; Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario Ausiliatrice
Countries: Italy; Italy; Italy; Italy; Italy; Italy; Italy; Italy; Italy; Italy
Enrollment: 100
Age range: 18 Years - 85 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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;
* Refusal to provide written informed consent.

Outcomes:
Usability and acceptability for therapists; Change from baseline in the Fugl-Meyer Assessment for the upper extremities - motor function (FMA-UE)