Integrating AI in Stroke Neurorehabilitation (AISN)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
Other Locations
France
CHU de Limoges
NOT_YET_RECRUITING
Limoges
Italy
San Camillo Hospital, IRCCS
RECRUITING
Venice
Romania
UMF
RECRUITING
Cluj-napoca
Spain
Parc Sanitari Sant Joan de Deu (SJDD)
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Sponsor
contact@eodyne.com
+34 931389642
Backup
Anna Mura
anna3.mura@gmail.com
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 192
Treatments
Experimental: RGS with AI-based Clinical Decision Support
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.
Active_comparator: RGS without AI-based Decision Support
Participants receive the same home-based RGS virtual reality rehabilitation, but exercise prescriptions are set and adjusted manually by clinicians without AI assistance.
No_intervention: Control Group - Standard Care
Participants receive usual post-stroke rehabilitation services available at their site, without access to the RGS@home platform.
Related Therapeutic Areas
Sponsors
Leads: Eodyne Systems SL
Collaborators: Universidad Miguel Hernandez de Elche

This content was sourced from clinicaltrials.gov