Clinical Development of a Tool for Optimized Self- and Hetero-diagnosis of Stroke Using Artificial Intelligence: Stage1- Collection of Video-clinical Data in a Pragmatic Situation.

Study Overview
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Brief Summary
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The study authors aim to form a collection of video-clinical data in a pragmatic situation to enable the development of relevant AI algorithms (for both hetero- and self-diagnosis modes). The aim is to optimize management through early diagnosis (self- and hetero-diagnosis) and thus to reduce sequelae disability. The study authors hypothesize that some stroke patients will be able to successfully perform a self-test consisting of a few exercises dictated by an application on a smartphone or tablet and recorded on video.

Official Title
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Clinical Development of a Tool for Optimized Self- and Hetero-diagnosis of Stroke Using Artificial Intelligence: Stage1- Collection of Video-clinical Data in a Pragmatic Situation.

Conditions
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Stroke, Cerebrovascular

Intervention / Treatment
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* Other: AI-STROKE application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated in the emergency department or hospitalized in the NICU at the CHU de Nîmes for suspected stroke or transient ischemic attack in the acute phase (<72h), with or without motor deficit Patient to be seen again in consultation within 4 months Patient has given free and informed consent and signed the consent form. If the patient is not in a position to give consent, it must be obtained, prior to filming the first video, from the designated trusted support person or relatives present. In this case, data will not be used until the patient is able to sign the consent (CNIL). Patient affiliated or beneficiary of a health insurance scheme Exclusion Criteria: Patients who do not speak or read French. Patient in a period of exclusion determined by another study. Patient under court protection, guardianship or curatorship. Pregnant, parturient or breast-feeding patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with suspected acute stroke<br> | Other: AI-STROKE application<br>* Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usable video recording made by the patient | Recording using AI-STROKE application | Day 0 | 
| Usable video recording made by the hospital worker | Recording using AI-STROKE application | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usable video recording made by the patient | Recording using AI-STROKE application | Month 3 | 
| Usable video recording made by the hospital worker | Recording using AI-STROKE application | Month 3 | 
| Feasibility of patient self-recording | Patient able to record without assistance: yes/no | Day 0 | 
| Feasibility of patient self-recording | Patient able to record without assistance: yes/no | Month 3 | 
| Acceptability of self-recording by patients | Patient accepting to self-record: Yes/no | Month 3 | 
| Patient-reported ease of self-recording | Visual numerical scale 0-10 | Day 0 | 
| Patient-reported ease of self-recording | Visual numerical scale 0-10 | Month 3 | 
| Stroke severity | NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist | Day 0 | 
| Stroke severity | NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist | Month 3 | 
| Degree of disability following stroke | mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist | Day 0 | 
| Degree of disability following stroke | mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence, Data bank, Video recording