• Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients

  NCT07456306

  Not yet recruitingInterventionalNot ApplicableUpdated Mar 6, 2026
• Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.

  NCT07199322

  Not yet recruitingInterventionalNot ApplicableUpdated Sep 30, 2025
• Using AI Systems to Optimize the Clinical Outcome of Stroke Patients

  NCT06828679

  RecruitingInterventionalNot ApplicableUpdated Dec 22, 2025
• Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)

  NCT06885502

  RecruitingInterventionalNot ApplicableUpdated Jan 6, 2026
• RGS@Home: Personalized 24/7 Home Care Post-stroke

  NCT04620707

  Unknown statusInterventionalNot ApplicableUpdated Nov 24, 2021
• Effect of Artificial Intelligence Based Gamification Training on Cognition and Functional Outcomes in Patients With Stroke

  NCT07209592

  Not yet recruitingInterventionalNot ApplicableUpdated Oct 7, 2025

ClinicalTrials.gov ID

NCT07138495

Lead Sponsor

Eodyne Systems SLINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

192Estimated

Last Update Posted

Dec 22, 2025Actual

Start Date

Oct 15, 2025Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

Official Title

Integrating AI in Stroke Neurorehabilitation (AISN)

Brief Summary

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.

Detailed Description

The AISN study addresses the gap in long-term, personalized stroke rehabilitation after hospital discharge by evaluating an enhanced digital therapy platform that combines the clinically validated Rehabilitation Gaming System (RGS) with a newly developed AI-based decision-support module. This AI component analyzes patient performance data to provide clinicians with diagnostic and prognostic insights, along with tailored exercise prescriptions.

The trial's key innovation is the formal validation of the AI module in real-world clinical settings, assessing its concordance with clinician decisions, predictive accuracy, and contribution to patient outcomes.

Participants will be randomized into three groups:

RGS+AI: Home-based RGS therapy with AI-driven recommendations for clinicians. RGS-AI: Home-based RGS therapy without AI support. Control: Standard rehabilitation care. The intervention phase will last 12 weeks, with daily home training for experimental groups, and follow-up at 20 weeks. In addition to standard clinical endpoints, the study will include predefined AI validation metrics, focusing on its potential as a certified medical device tool for scalable, personalized rehabilitation delivery.

• Stroke

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Eodyne Systems SLINDUSTRY

Collaborators

Universidad Miguel Hernandez de ElcheOTHER

adinadora@elearn.umfcluj.ro+40 0264593884