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Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
NCT07199322 · Fondazione Don Carlo Gnocchi ETS · Updated 30 Sept 2025
- What is being tested
- Robotic upper limb rehabilitation in patients with Stroke with AI support; Robotic upper limb rehabilitation in patients with Stroke without AI support
- For
- Stroke; Stroke Ischemic; Stroke Hemorrhagic; Upper Limb Rehabilitation
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 85 years. About 100 people. The full rules are on the registry page.
- Where
- Italy (10 sites)
- When
- Starts or started Sept 2025, ends Dec 2026. Registered 30 Sept 2025.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Fondazione Don Carlo Gnocchi, Polo Specialistico RiabilitativoSant'Angelo dei Lombardi, AV, Italy
- Fondazione Don Carlo Gnocchi, Centro SpalenzaRovato, BS, Italy
- IRCSS Fondazione Don Carlo GnocchiFlorence, FI, Italy
- Fondazione Don Carlo Gnocchi, Polo Specialistico RiabilitativoTricarico, Mount, Italy
- Scuola Superiore Sant'AnnaPisa, PI, Italy
- Fondazione Don Carlo Gnocchi, Centro GalaAcerenza, PZ, Italy
- Fondazione Policlinico Universitario Campus Bio-MedicoRoma, RM, Italy
- Fondazione Don Carlo Gnocchi, Centro Santa Maria della ProvvidenzaRoma, RM, Italy
- Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligureLa Spezia, SP, Italy
- Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario AusiliatriceTorino, TO, Italy
