Status:
NOT_YET_RECRUITING
Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Fondazione Policlinico Universitario Campus Bio-Medico
Scuola Superiore Sant'Anna di Pisa
Conditions:
Stroke
Stroke Ischemic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 f...
Detailed Description
The CO-AIDER study is a multicenter, randomized, controlled, two-arm, non-profit clinical trial validating an AI-based decision support system (AI-DSS) in robotic upper limb rehabilitation for stroke ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07199322
Start Date
September 1 2025
End Date
December 1 2026
Last Update
September 30 2025
Active Locations (10)
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1
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi, AV, Italy, 83054
2
Fondazione Don Carlo Gnocchi, Centro Spalenza
Rovato, BS, Italy, 25038
3
IRCSS Fondazione Don Carlo Gnocchi
Florence, FI, Italy, 50143
4
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Tricarico, Mount, Italy, 75019