BridgeMD
New treatment option for Stroke
Official title Integrating AI in Stroke Neurorehabilitation
ClinicalTrials.gov ID: NCT07138495
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Age \> 18 years old
- Able to sit on a chair or a wheelchair and interact with RGS during an entire session
You likely can't join 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...
- 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
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Limoges, France
- Venice, Veneto, Italy
- Cluj-Napoca, Romania
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Limoges, France; Venice, Veneto, Italy; Cluj-Napoca, Romania; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.