Integrating AI in Stroke Neurorehabilitation
AISN
1 other identifier
interventional
192
4 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Oct 2025
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
December 22, 2025
December 1, 2025
1.2 years
August 14, 2025
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Upper limb motor change
Evaluation with the ARAT scale
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
Secondary Outcomes (5)
Cognitive function change
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
Disability evaluation
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
Emotional change
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
Quality of life and Health status
From enrollment to the end of treatment at 12 weeks, and follow-up at 20 weeks
Therapists' qualitative evaluation of the AI-based decision support system performance
At the end of the study, at 20 weeks.
Other Outcomes (1)
RGS intrinsic measures change
At enrollment, 2, 4, 8 weeks, end of treatment (12 weeks), and follow-up (20 weeks)
Study Arms (3)
RGS with AI-based Clinical Decision Support
EXPERIMENTALParticipants 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.
RGS without AI-based Decision Support
ACTIVE COMPARATORParticipants receive the same home-based RGS virtual reality rehabilitation, but exercise prescriptions are set and adjusted manually by clinicians without AI assistance.
Control Group - Standard Care
NO INTERVENTIONParticipants receive usual post-stroke rehabilitation services available at their site, without access to the RGS@home platform.
Interventions
The 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.
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eodyne Systems SLlead
- Universidad Miguel Hernandez de Elchecollaborator
Study Sites (4)
CHU de Limoges
Limoges, France
San Camillo Hospital, IRCCS
Venice, Veneto, 30126, Italy
UMF
Cluj-Napoca, Romania
Parc Sanitari Sant Joan de Deu (SJDD)
Barcelona, Spain
Related Publications (9)
Rabadi MH, Rabadi FM. Comparison of the action research arm test and the Fugl-Meyer assessment as measures of upper-extremity motor weakness after stroke. Arch Phys Med Rehabil. 2006 Jul;87(7):962-6. doi: 10.1016/j.apmr.2006.02.036.
PMID: 16813784BACKGROUNDLang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upper-extremity measures early after stroke. Arch Phys Med Rehabil. 2008 Sep;89(9):1693-700. doi: 10.1016/j.apmr.2008.02.022.
PMID: 18760153BACKGROUNDHsieh YW, Wu CY, Lin KC, Chang YF, Chen CL, Liu JS. Responsiveness and validity of three outcome measures of motor function after stroke rehabilitation. Stroke. 2009 Apr;40(4):1386-91. doi: 10.1161/STROKEAHA.108.530584. Epub 2009 Feb 19.
PMID: 19228851BACKGROUNDBallester BR, Antenucci F, Maier M, Coolen ACC, Verschure PFMJ. Estimating upper-extremity function from kinematics in stroke patients following goal-oriented computer-based training. J Neuroeng Rehabil. 2021 Dec 31;18(1):186. doi: 10.1186/s12984-021-00971-8.
PMID: 34972526BACKGROUNDCameirao MS, Badia SB, Oller ED, Verschure PF. Neurorehabilitation using the virtual reality based Rehabilitation Gaming System: methodology, design, psychometrics, usability and validation. J Neuroeng Rehabil. 2010 Sep 22;7:48. doi: 10.1186/1743-0003-7-48.
PMID: 20860808BACKGROUNDDuncan PW, Bushnell C, Sissine M, Coleman S, Lutz BJ, Johnson AM, Radman M, Pvru Bettger J, Zorowitz RD, Stein J. Comprehensive Stroke Care and Outcomes: Time for a Paradigm Shift. Stroke. 2021 Jan;52(1):385-393. doi: 10.1161/STROKEAHA.120.029678. Epub 2020 Dec 22.
PMID: 33349012BACKGROUNDMaier M, Ballester BR, Leiva Banuelos N, Duarte Oller E, Verschure PFMJ. Adaptive conjunctive cognitive training (ACCT) in virtual reality for chronic stroke patients: a randomized controlled pilot trial. J Neuroeng Rehabil. 2020 Mar 6;17(1):42. doi: 10.1186/s12984-020-0652-3.
PMID: 32143674BACKGROUNDMoher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PMID: 20332511BACKGROUNDMaier M, Ballester BR, Verschure PFMJ. Principles of Neurorehabilitation After Stroke Based on Motor Learning and Brain Plasticity Mechanisms. Front Syst Neurosci. 2019 Dec 17;13:74. doi: 10.3389/fnsys.2019.00074. eCollection 2019.
PMID: 31920570BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2025
First Posted
August 22, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
No Individual participant data (IPD) will be shared. Only aggregated results or fully de-identified datasets may be provided to external researchers to ensure transparency while protecting confidentiality.