Actively Recruiting
Integrating AI in Stroke Neurorehabilitation
Led by Eodyne Systems SL · Updated on 2025-12-22
192
Participants Needed
4
Research Sites
63 weeks
Total Duration
On this page
Sponsors
E
Eodyne Systems SL
Lead Sponsor
U
Universidad Miguel Hernandez de Elche
Collaborating Sponsor
AI-Summary
What this Trial Is About
The AISN multicenter randomized controlled trial will assess the effectiveness of a novel artificial intelligence (AI)-based clinical decision-support system integrated into the Rehabilitation Gaming System (RGS) for home-based post-stroke rehabilitation. Approximately 192 participants ≥6 months post-stroke will be recruited across several European centers and assigned to one of three groups: RGS with AI decision support, RGS without AI, or standard care. The primary outcome is upper limb motor improvement for stroke patients, with secondary measures including cognitive function, independence, quality of life, usability, cost-effectiveness, and AI-based support performance.
CONDITIONS
Official Title
Integrating AI in Stroke Neurorehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 6 months after first-ever ischemic or intracerebral hemorrhagic stroke
- Mild to moderate weakness in one upper limb with Medical Research Council score 2 or higher
- Action Research Arm Test score less than 50
- Age over 18 years
- Able to sit in a chair or wheelchair and use the Rehabilitation Gaming System for a full session
- Minimal experience with smartphone technology as judged by a clinician
- Willing to participate in the Rehabilitation Gaming System therapy
- Signed informed consent form
You will not qualify if you...
- Diagnosis of epilepsy
- Severe cognitive impairments preventing participation as judged by clinicians
- Severe impairments such as proximal spasticity, communication disabilities (sensory, Wernicke aphasia, or apraxia), major pain (VAS over 75-100 mm), or orthopedic devices interfering with therapy
- Unable to use the Rehabilitation Gaming System app independently without caregiver support
- No experience with smartphone technology as judged by clinicians
- Refusal to sign informed consent
- Current or planned participation in another clinical trial during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU de Limoges
Limoges, France
Not Yet Recruiting
2
San Camillo Hospital, IRCCS
Venice, Veneto, Italy, 30126
Actively Recruiting
3
UMF
Cluj-Napoca, Romania
Actively Recruiting
4
Parc Sanitari Sant Joan de Deu (SJDD)
Barcelona, Spain
Not Yet Recruiting
Research Team
S
Sponsor
CONTACT
A
Anna Mura
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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