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
This trial does not accept healthy volunteersQualifiers
≥ 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
Design model
Parallel
Treatments tested in this trial
AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy
DeviceThe personalized RGS app rehabilitation is a home-based, virtual reality therapy platform for motor and cognitive stroke recovery. Therapy tasks are gamified, task-specific, and adapt in difficulty based on real-time performance. An AI-driven clinical decision support system personalizes and updates exercise prescriptions after each session, with optional clinician adjustments. Integrated wearable sensors (RGSwear) track real-world activity and adherence. Data are securely uploaded to a cloud-based platform for remote monitoring. This is the first multicenter, international RCT to test AI-personalized VR rehabilitation at home with up to 12-month follow-up, combined with cost-effectiveness and usability evaluation.
Treatment groups
192 Participants
are divided into 3 treatment groupsGroup A: RGS with AI-based Clinical Decision SupportExperimental treatment 1 intervention
Group B: RGS without AI-based Decision SupportActive comparator 1 intervention
Group C: Control Group - Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Upper limb motor change
Evaluation with the ARAT scale
Time frame
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeksSecondary outcomes
1
Cognitive function change
Cognitive evaluation with TAP (alertness, sustained and divided attention, selective attention/flexibility, spatial attention, and working memory).
Time frame
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks2
Disability evaluation
Assessment of global disability with the Modified Ranking Scale - mRS
Time frame
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks3
Emotional change
Assessed with the Hamilton Depression Scale
Time frame
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks4
Quality of life and Health status
Assessed with EQ-5D-5L questionnaire
Time frame
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeksOther outcomes
1
RGS intrinsic measures change
RGS intrinsic measures, i.e., exercise difficulty settings and kinematics RGS protocols for motor and cognitive assessment
Time frame
At enrollment, 2, 4, 8 weeks, end of treatment (12 weeks), and follow-up (20 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eodyne Systems SL
Lead sponsor
Universidad Miguel Hernandez de Elche
Collaborator
Source ClinicalTrials.gov