Study Title: A Soft, Wireless, and Wearable Digital Health Platform for continuous Frailty Assessment. (#2005648028)
Principle Investigator: Dr. Philipp Gutruf
Sponsor:  The Flinn Foundation
 
Description of Research
Current technology is not able to provide the high-fidelity data streams needed to detect subtle changes that are indicative of onset frailty on the time scale needed. Our proposed technology is a chronically wearable device that aims to provide the high-fidelity data streams needed for frailty assessment, in a form factor that enables long term data recording. The system is wireless, battery-free and soft, maximizing patient comfort without the need for interaction with the system. This study aims to assess the fidelity of the system in capturing biomarkers associated with frailty and compare the data with the gold-standard equivalent. In this set of experiments, participants will be asked to perform various tasks while wearing the device. The device will record motion of the patients during these activities. Data recorded will be used to determine different variations in in gait parameters to assess mobility of the participant. This data will be compared to data collected using standard measurement devices that utilize bulky, battery-powered formfactors. Evaluation of the proposed device’s ability to identify subtle differences in gait parameters will be used for confirmation of the hypothesis and modification of the current design.

Why is this study being done?
The purpose of this study is to evaluate a novel wearable device platform in its ability to accurately detect and assess frailty status in aging populations. The proposed device is a long-term, battery-free, soft solution that maximizes patient comfort without the need for user interaction. Validation of its superior data collection capabilities is a key aspect of the device that is being investigated during this trial.

What will happen if I take part in this study?
You will be asked to complete a series of surveys to gather information regarding the participant’s demographic, frailty status, cognitive function, and level of daily activity. Once these clinical measurements have been gathered, you will be fitted and equipped with the investigational device for assessment of motor function tests. These tests include a 60-meter walk, a timed-up-and-go test, and five (5) repetitions of a sit-to-stand test.

Where will this study take place?
This study will be conducted at the Bioscience Research Laboratories (BSRL) located at the University of Arizona. The address is 1230 N Cherry Ave. Tucson, Arizona 85721.

How long will I be in this study?
You will be asked to commit approximately 1.5 hours of your time.

Will I be paid for taking part in this study?
You will be compensated $25 dollars for participation in this study. Compensation will be handed to you at the end of the trial period

Contact
If you are interested in learning more about this study, please contact Tucker Stuart at 503-341-5207.