Phase II and Phase IIB STTR: Portable Device for Telecare Monitoring of Elderly People
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fraility
- Sponsor
- BioSensics
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Average sit-to-stand transition time over 48-hour monitoring period
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a single wearable motion sensor that is worn on the torso. The objectives of this observational study are the following: 1) to test the efficacy of PAMSys for objectively assessing a persons risk of falling based on activity data measured during activities of daily living and 2) to test the efficacy of PAMSys for identifying precise early physical activity or functioning indicators of frailty in those who are pre-frail or frail as compared to non-frail controls.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Community-dwelling ambulatory men or women ages 65 and above
Exclusion Criteria
- •Mental Status Mini Exam score \< 23
- •Those who are unwilling or unable to comprehend informed consent
Outcomes
Primary Outcomes
Average sit-to-stand transition time over 48-hour monitoring period
Time Frame: Averaged over days 1 and 2
Eligible subjects will receive a PAMSys motion sensors and necessary instructions for proper use. They will then wear the motion sensor continuously for 48 hours. PAMSys will record the duration of each sit-to-stand transition during this 48 hour monitoring period. The primary outcome measure is the average of these durations.
Secondary Outcomes
- Average stand-to-sit transition time during 48 hours of continuous monitoring(Averaged over days 1 and 2)