AI-supported home virtual reality rehabilitation for arm recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• San Camillo Hospital, IRCCS
  Venice, Veneto, Italy Recruiting
• Umf
  Cluj-Napoca, Romania Recruiting
• CHU de Limoges
  Limoges, France Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Dual-task balance training plus computer-based cognitive training after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.