Status:
RECRUITING
Integrating AI in Stroke Neurorehabilitation
Lead Sponsor:
Eodyne Systems SL
Collaborating Sponsors:
Universidad Miguel Hernandez de Elche
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 Reh...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT07138495
Start Date
October 15 2025
End Date
December 30 2026
Last Update
December 22 2025
Active Locations (4)
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1
CHU de Limoges
Limoges, France
2
San Camillo Hospital, IRCCS
Venice, Veneto, Italy, 30126
3
UMF
Cluj-Napoca, Romania
4
Parc Sanitari Sant Joan de Deu (SJDD)
Barcelona, Spain