Tests AI-guided robotic arm therapy for upper limb recovery after stroke
Compares AI-guided and therapist-set robotic arm rehabilitation in adults with stroke.
Plain-language title generated from the registry record
Registry title: Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
Key facts
- Where
- Acerenza, Florence, La Spezia, Pisa, Roma, Rovato, Sant'Angelo dei Lombardi, Torino, and Tricarico, ItalySee the 10 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07199322, who can take part
Where in Italy
- Fondazione Don Carlo Gnocchi, Centro GalaAcerenza, ItalyNo longer taking part
- IRCSS Fondazione Don Carlo GnocchiFlorence, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligureLa Spezia, ItalyNo longer taking part
- Scuola Superiore Sant'AnnaPisa, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi - Centro Santa Maria della ProvvidenzaRoma, ItalyNo longer taking part
- Fondazione Policlinico Universitario Campus Bio-medicoRoma, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi, Centro SpalenzaRovato, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi, Polo Specialistico RiabilitativoSant'Angelo dei Lombardi, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario AusiliatriceTorino, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativoTricarico, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Don Carlo Gnocchi ETS
- Trial code
- NCT07199322
- Record updated
- 30 September 2025
- Original description
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.Read full original descriptionShow less
Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
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.
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: Concurrent participation in another clinical trial for upper limb rehabilitation following stroke; Behavioral or cognitive disorders and/or reduced compliance; Severe spasticity or hypertonia in the affected limb (Modified Ashworth Scale (MAS) > 3); Severe visual impairments; Refusal to provide written informed consent.