RecruitingNot ApplicableNCT07138495

Integrating AI in Stroke Neurorehabilitation

Integrating AI in Stroke Neurorehabilitation (AISN)

Sponsor

Eodyne Systems SL

Enrollment

192 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

≥ 6 months post-stroke
Patients presenting a first-ever ischemic or intracerebral hemorrhagic stroke
Mild to Moderate unilateral upper limb motor impairment: Medical Research Council proximal and distal upper limb MRC ≥2; Action Research Arm Test: ARAT score < 50 (0 = no function, 57 = no functional limitation).
Age > 18 years old
Able to sit on a chair or a wheelchair and interact with RGS during an entire session
Minimal experience with smartphone technology based on the clinician's opinion
Willing to participate in the RGS therapy
Sign the Informed Consent Form

Exclusion Criteria7

Diagnosis with Epilepsy
Severe cognitive capabilities preventing the execution of the experiment or according to clinicians' criteria.
Severe associated impairment such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia or apraxia), major pain (VAS > 75-100 mm), orthopedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale > 3)
Unable to use the RGS app independently according to the clinician's observations and lacking support from a caregiver to use the RGS app
No experience with smartphone technology or based on the clinician's opinion.
Refusal to sign the Informed Consent
Participating or planning to participate in another trial while being part of the present study.

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Interventions

DEVICEAI-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.