Testing the Stroke Alarm Device to Detect Early Stroke with Unilateral Arm Weakness in Adults 50 and Older

What this Trial Is About

Researchers are evaluating the effectiveness of the CE-marked wearable device called Stroke Alarm to detect the start of a stroke with unilateral arm weakness within three hours of onset. This multicenter, prospective observational trial includes a single group using the device and compares results to a matched control group from a Swedish national stroke registry. The study aims to achieve at least 60% sensitivity and 80% specificity in identifying strokes using clinical diagnosis as the standard. Participants who meet eligibility criteria will receive the Stroke Alarm, which consists of sensor bracelets worn continuously for three months. The device pairs with a smartphone app that alerts chosen alarm recipients via SMS if stroke symptoms are detected. The study involves baseline data collection at enrollment, follow-up at three months, and additional data from national registry sources. Participants will use the device during normal daily activities and can add multiple alarm recipients who will be notified if the device detects signs of stroke. During the study, researchers will monitor device alarms, timing of stroke onset detection, hospital arrival times, and any treatments or complications related to the device. Participants are assessed at enrollment and after three months, with data collected from electronic records and national registries. The total study involvement is three months of device use with follow-up and data review to evaluate how well the device detects stroke events and triggers alarms for timely intervention.

Stroke Alarm Efficacy Trial