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Clinical Trials in Italy / NCT07138495
Recruiting Not applicable

Integrating AI in Stroke Neurorehabilitation

NCT07138495 · tracked via the Priya Life Science Italy tracker
Sponsor
Eodyne Systems SL
Phase
Not applicable
Started
2025-10-15
Last updated
2025-12-22

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * ≥ 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 Criteria * 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.

Primary outcome measure(s)

  • Upper limb motor change — From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
    Evaluation with the ARAT scale

Trial sites (4)

FacilityCityRegionStatus
CHU de Limoges Limoges France Not Yet Recruiting
San Camillo Hospital, IRCCS Venice Veneto Recruiting
UMF Cluj-Napoca Romania Recruiting
Parc Sanitari Sant Joan de Deu (SJDD) Barcelona Spain Not Yet Recruiting

Other trials for the same condition

Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training Recruiting
Design and Validation of Innovative Strategies Based on Dual-Task Approach Active, not recruiting
Focal Vibration Therapy in Post-stroke Shoulder Pain Starting soon
PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults Starting soon
Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07138495 on ClinicalTrials.gov ↗ ← All trials in Italy