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Clinical Trial Summary

This is a single-arm, longitudinal, observational study on the use of wearable sensors and digital health technology to measure fall frequency and motor, speech, and cognitive function in patients with PSP over the course of approximately one year. Participants will perform supervised remote assessments monthly and in-person assessments approximately every 6 months.


Clinical Trial Description

The primary objective of this study is to determine the feasibility of using wearable sensors and digital health technology to remotely monitor patients with possible or probable PSP. Secondary objectives are to measure PSP progression using sensor-derived motor and tablet-derived speech and cognitive measures. In brief, 40-50 individuals with possible or probable PSP will be enrolled at 4-5 sites in the U.S. and followed for one year. During the monitoring period (1 year), a wearable pendant sensor (PAMSys, BioSensics) will be used to monitor falls and physical activity (step counts) of all participants during activities of daily living (ADL). On a monthly basis, participants will have televideo conferences with the sites to perform supervised gait and balance tasks while wearing 3 LEGSys (BioSensics) sensors. Using a study-supplied tablet, participants will also perform cognitive tests including fluency, color trails and go-no-go tapping tests. Participants will undergo more extensive testing every 3 months including the PSPRS, MoCA, quality of life questionnaires and functional rating scales which will be performed remotely (virtually). Approximately 6 months participants will undergo an in-person PSPRS (to coincide with their clinic appointments). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04753320
Study type Observational
Source Massachusetts General Hospital
Contact Mansi Sharma, BS
Phone 617-643-2400
Email msharma13@mgh.harvard.edu
Status Recruiting
Phase
Start date May 5, 2021
Completion date December 2024

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