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Taking people in ItalyNo phase

Testing AI-guided virtual reality rehabilitation at home after stroke

Tests an AI-guided virtual reality system for home rehabilitation in adults recovering from stroke.

Key facts

Who runs it
Eodyne Systems SL
Where
Venice, ItalySee the siteAlso in 3 other countries, 3 sites
Trial code
Registry title
Integrating AI in Stroke Neurorehabilitation
Status
Recruiting
People taking part
192 people, planned
Started
15 Oct 2025
Expected to end
30 Dec 2026
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy
Record updated
22 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a first stroke at least 6 months ago and have mild to moderate weakness in one arm. They would do home-based rehabilitation with the Rehabilitation Gaming System (RGS).

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
At least 6 months after a first-ever ischemic or intracerebral hemorrhagic stroke, with mild to moderate motor impairment in one arm (Medical Research Council proximal and distal upper limb MRC ≥2; Action Research Arm Test ARAT score < 50).

Main reasons for not taking part

  • Epilepsy
  • Severe cognitive problems that prevent doing the study
  • Severe other impairments, such as communication disabilities or major pain (VAS > 75-100 mm)
  • Cannot use the RGS app independently and has no caregiver to help
  • No experience with smartphone technology, in the clinician's opinion

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • ≥ 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

Who cannot take part

  • 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)
  • 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

Where in Italy

Also in 3 other countries, 3 sites

  • San Camillo Hospital, IRCCSVenice, ItalyContact: Francesca BurgioTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • RGS with AI-based Clinical Decision SupportTreatment being tested

    Participants receive home-based virtual reality rehabilitation using the Rehabilitation Gaming System (RGS@home), with exercise prescriptions personalized by an AI-driven clinical decision support system. Clinicians can review and adjust these prescriptions remotely.

    Treatment: AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy

  • RGS without AI-based Decision SupportExisting treatment, for comparison

    Participants receive the same home-based RGS virtual reality rehabilitation, but exercise prescriptions are set and adjusted manually by clinicians without AI assistance.

    Treatment: AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy

  • Control Group - Standard CareNo study treatment, for comparison

    Participants receive usual post-stroke rehabilitation services available at their site, without access to the RGS@home platform.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Integrating AI in Stroke Neurorehabilitation (AISN)
Plain-language title
Testing AI-guided virtual reality rehabilitation at home after strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 December 2025