Condition: Stroke · Sponsor: Eodyne Systems SL
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
Sponsor · +34 931389642 · contact@eodyne.com
Anna Mura · anna3.mura@gmail.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| CHU de Limoges | Limoges, France | Not Yet Recruiting |
| San Camillo Hospital, IRCCS | Venice, Veneto, Italy | Recruiting |
| UMF | Cluj-Napoca, Romania | Recruiting |
| Parc Sanitari Sant Joan de Deu (SJDD) | Barcelona, Spain | Not Yet Recruiting |
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