NCT07138495 Integrating AI in Stroke Neurorehabilitation
| NCT ID | NCT07138495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eodyne Systems SL |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2025-10-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07138495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07138495 currently recruiting?
Yes, NCT07138495 is actively recruiting participants. Contact the research team at contact@eodyne.com for enrollment information.
Where is the NCT07138495 trial being conducted?
This trial is being conducted at Limoges, France, Venice, Italy, Cluj-Napoca, Romania, Barcelona, Spain.
Who is sponsoring the NCT07138495 clinical trial?
NCT07138495 is sponsored by Eodyne Systems SL. The trial plans to enroll 192 participants.
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