NCT07199322Not yet recruiting
Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Sept 2025
- Start date
- Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT07199322
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Sept 2025 to the primary completion date, Dec 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another clinical trial for upper limb rehabilitation following stroke;
Other illness
- Behavioral or cognitive disorders and/or reduced compliance;
Other
- Severe spasticity or hypertonia in the affected limb (Modified Ashworth Scale (MAS) \> 3);
- Severe visual impairments;
- Refusal to provide written informed consent.
Who the study is looking for
- 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).
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Don Carlo Gnocchi, Centro Gala Coordinator of this site? Confirm its status | Acerenza | Italy | Unknown status |
| IRCSS Fondazione Don Carlo Gnocchi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligure Coordinator of this site? Confirm its status | La Spezia | Italy | Unknown status |
| Scuola Superiore Sant'Anna Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Fondazione Policlinico Universitario Campus Bio-medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi, Centro Spalenza Coordinator of this site? Confirm its status | Rovato | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo Coordinator of this site? Confirm its status | Sant'Angelo dei Lombardi | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario Ausiliatrice Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo Coordinator of this site? Confirm its status | Tricarico | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.