NCT05959746招募中不适用
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.
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年8月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Usable video recording made by the patient
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients with suspected acute stroke
Experimental
干预措施: AI-STROKE application (Other)
结局指标
主要结局
Usable video recording made by the patient
时间窗: Day 0
Recording using AI-STROKE application
Usable video recording made by the hospital worker
时间窗: Day 0
Recording using AI-STROKE application
次要结局
- Acceptability of self-recording by patients(Month 3)
- Patient-reported ease of self-recording(Month 3)
- Feasibility of patient self-recording(Month 3)
- Degree of disability following stroke(Month 3)
- Usable video recording made by the patient(Month 3)
- Usable video recording made by the hospital worker(Month 3)
- Stroke severity(Month 3)
研究者
研究点 (2)
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