Integrating AI in Stroke Neurorehabilitation
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEodyne Systems SL
About this trial
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.
Eligibility criteria
Qualifiers
≥ 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy
Treatment groups
192 Participants
are divided into 3 treatment groupsSponsors and collaborators
Eodyne Systems SL
Lead sponsor
Universidad Miguel Hernandez de Elche
Collaborator
Source ClinicalTrials.gov