Validation of Corsano CardioWatch 287-2B Activity Monitoring in Healthy Children

Rationale
Wearable devices are increasingly used to monitor physical activity in clinical and research settings, but their accuracy in children remains under-evaluated. The ActiGraph accelerometer is widely regarded as the gold standard for measuring physical activity and energy expenditure. However, its bulkiness and cost limit its suitability for continuous use in everyday pediatric settings.

This study aims to validate the Corsano CardioWatch 287-2B and the Hexoskin Smart Shirt against the ActiGraph wGT3X-BT or GT3X-03, focusing on activity level tracking, step counts, and energy expenditure in healthy children. A secondary goal is to assess user-friendliness and device adherence.

Study Objectives
Primary Outcome
• Validation of physical activity levels, step counts, and energy expenditure measured by the Corsano and Hexoskin devices, compared to ActiGraph.

Secondary Outcomes
• Agreement in respiratory and heart rate measurements (Corsano vs. Hexoskin)
• Evaluation of device adherence and duration of wear
• Subjective user experience and comfort, collected via participant questionnaires

Study Design
This is a prospective, single-center validation study involving healthy pediatric volunteers. Each participant wears three CE-certified devices simultaneously:
• Corsano CardioWatch 287-2B (wrist)
• Hexoskin Smart Shirt (torso)
• ActiGraph wGT3X-BT or GT3X-03 (waist)
Demographic and anthropometric data are collected at baseline. All wearable devices record activity metrics during a standardized observation period. Device wear time is logged both digitally and via participant diaries.

Inclusion Criteria
Healthy children aged 6–17 years
Written informed consent from parents/guardians and assent from participants

Exclusion Criteria
Medical conditions limiting physical activity
Inability to wear one or more of the devices due to dermatological or anatomical reasons

Current Status
The study commenced on January 24, 2025. As of now, 22 of 30 targeted participants have been enrolled. Inclusion is ongoing and may be expanded depending on interim findings. No device-related issues or dropouts have occurred.

Timeline
Status: Recruiting patients
Start Date: January 24, 2025
Estimated Duration: 3–4 months
Expected Total Enrolment: 30 (with potential expansion)

Study center
Erasmus Medical Center (EMC), Rotterdam, The Netherlands – SHTC Unit
In collaboration with Delft University of Technology

Interested in our Trial Programme?

Corsano Cardiowatch Bracelets enable continuous monitoring with multiple algorithms. Corsano is working closely with cardiologists, scientists, hospitals, patients, and research organisations.  Scientific research demonstrates the legitimacy of Cardiowatch 287 algorithms. 

We are currently performing pilots with selected clients. Contact us if you want to know more!

Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture up to 19 vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring.  
 
The bracelet monitor offers flexibility to set data collection intervals by minute, by second or 25Hz, 32 Hz or 128 Hz. We measure Heart Rate, RR intervals, Breathing Rate, A-Fib detection, Skin Temperature, Activity and Sleep. SpO2, Core Body Temperature, ECG and Blood Pressure are in development.  
 
Clinical accuracy is paramount for us. In addition to third parties' algorithms, i.e. from Philips, we run our proprietary algorithms to realize superior data accuracy. Corsano technology has been clinically validated in major academic hospitals. The bracelet is manufactured under ISO 13485 and CE-MDR compliance. The process for FDA Clearance has started. 
 
Our end-to-end solution consists of light-weight and comfortable bracelets with a patient research portal. We have developed and produced over 200’000 devices. The Corsano platform has been optimized on connections, data buffers and battery life up to 15 days. We offer access to raw continuous high frequency data through API and cloud-to-cloud solutions. 
 

The founders of Corsano Health have over 100 years of experience in the Swiss Watch industry, with deep experience about ergonomic design and materials for wearables that are worn 24/7.