Integrating AI in Stroke Neurorehabilitation
Recruiting now · Not applicable
Conditions studied: Stroke
In brief
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.
Key facts
- Study ID
- NCT07138495
- Run by
- Eodyne Systems SL
- People needed
- 192
- Starts
- 2025-10-15
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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.
Where it is running
- San Camillo Hospital, IRCCS — Venice, Veneto, Italy (enrolling)
- UMF — Cluj-Napoca, Romania (enrolling)
- Parc Sanitari Sant Joan de Deu (SJDD) — Barcelona, Spain
- CHU de Limoges — Limoges, France
Full record on ClinicalTrials.gov
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