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Integrating AI in Stroke Neurorehabilitation
Sponsor: Eodyne Systems SL
Summary
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.
Official title: Integrating AI in Stroke Neurorehabilitation (AISN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2025-10-15
Completion Date
2026-12-30
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy
The personalized RGS app rehabilitation is a home-based, virtual reality therapy platform for motor and cognitive stroke recovery. Therapy tasks are gamified, task-specific, and adapt in difficulty based on real-time performance. An AI-driven clinical decision support system personalizes and updates exercise prescriptions after each session, with optional clinician adjustments. Integrated wearable sensors (RGSwear) track real-world activity and adherence. Data are securely uploaded to a cloud-based platform for remote monitoring. This is the first multicenter, international RCT to test AI-personalized VR rehabilitation at home with up to 12-month follow-up, combined with cost-effectiveness and usability evaluation.
Locations (4)
CHU de Limoges
Limoges, France
San Camillo Hospital, IRCCS
Venice, Veneto, Italy
UMF
Cluj-Napoca, Romania
Parc Sanitari Sant Joan de Deu (SJDD)
Barcelona, Spain