AI-supported home virtual reality rehabilitation for arm recovery after stroke
Integrating AI in Stroke Neurorehabilitation (AISN)
This trial tests if adding an AI decision-support module to a home-based virtual reality rehabilitation system improves upper-limb recovery for adults at least six months after a first stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eodyne Systems SL Industry-sponsored |
| Locations | 4 sites (Limoges and 3 other locations) |
| Trial ID | NCT07138495 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial will enroll about 192 adults ≥6 months after a first ischemic or hemorrhagic stroke and randomize them to one of three groups: RGS with AI decision support, RGS without AI, or standard care. Participants in the experimental arms will do daily home-based training using the Rehabilitation Gaming System for 12 weeks with follow-up at 20 weeks. The primary outcome is improvement in upper limb motor function, with secondary endpoints including cognitive function, independence, quality of life, usability, cost-effectiveness, and predefined AI validation metrics. The AI module analyzes patient performance to generate diagnostic and prognostic insights and tailored exercise prescriptions, and the trial will measure its concordance with clinician decisions and predictive accuracy in real-world settings.
Who should consider this trial
Good fit: Adults (>18) at least six months after a first ischemic or intracerebral hemorrhagic stroke with mild-to-moderate unilateral upper-limb impairment (ARAT <50 and MRC ≥2), able to sit and use the system, with minimal smartphone experience and willing to consent to home RGS therapy.
Not a fit: Patients with epilepsy, severe cognitive impairment or communication deficits, major spasticity or pain, or orthopedic issues that prevent correct use of the device are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could deliver more personalized, scalable home rehabilitation and improve arm function after stroke using AI-guided exercises.
How similar studies have performed: Virtual reality and digital home-rehabilitation approaches have shown benefits in prior work and the RGS platform is clinically used, but formal real-world validation of an AI decision-support module of this type remains novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Limoges and 3 other locations
- 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)
Study contacts
- Study coordinator: Sponsor
- Email: contact@eodyne.com
- Phone: +34 931389642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.