NCT07138495Recruiting
Integrating AI in Stroke Neurorehabilitation
Integrating AI in Stroke Neurorehabilitation (AISN)
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Eodyne Systems SL
- Diseases
- Stroke
- NCT number
- NCT07138495
What you commit to
- Study type: Interventional
- Planned participants: 192
- From 15 Oct 2025 to the primary completion date, 30 Dec 2026
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis with Epilepsy
- 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)
Other
- Severe cognitive capabilities preventing the execution of the experiment or according to clinicians' criteria.
- 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.
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parc Sanitari Sant Joan de Deu (SJDD) Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Not yet recruiting |
| San Camillo Hospital, IRCCS Coordinator of this site? Confirm its status | Venice | Italy | Recruiting |
| UMF Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.