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RECRUITING
NCT07138495
NA

Integrating AI in Stroke Neurorehabilitation

Sponsor: Eodyne Systems SL

View on ClinicalTrials.gov

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

DEVICE

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