Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors (GFD1)
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|ClinicalTrials.gov Identifier: NCT02272933|
Recruitment Status : Recruiting
First Posted : October 23, 2014
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls Gait, Unsteady||Device: Smart Slipper Device: Belt-Clip Sensor||Not Applicable|
Medical monitoring systems have become an important area of research and development due to the possibility of allowing improved quality of life and care while reducing overall medical costs.
Significance of the study:
The study is significant because it will allow researchers to understand the efficacy of the autonomous sensor system used with actual residents of a geriatric care center. This study is one of the first attempts to monitor movements of geriatric residents as they go about their activities of daily living. This type of system has the potential to improve the quality of life and safety of geriatric patients.
The development of autonomous patient monitoring technologies that will eventually improve the quality of life and safety of patients in geriatric care facilities and other environments.
Determine the performance and usability of the wearable sensor system in a geriatric care facility with actual residents going about their daily lives.
- Determine performance of motion data collect ion system for monitoring geriatric residents as they go about their daily life in a geriatric center
- Determine tolerability of wearing sensors by geriatric residents
- Understand how medical staff interacts with monitored residents and the sensor devices
- Determine if the sensor system's algorithms can identify falls
- Analyze the motion data generated by the system to determine system performance. The list of performance metrics will include: (a) system up-time, (b) continuity of data collection (c) sensor device failure rate, (d) sensor device battery life (e) simultaneous collection of data when multiple monitored residents are in the same localized area.
- Assess the tolerability of wearing the devices over the course of a day using a survey administered to residents.
- Assess the usability of the sensor system using a survey administered to care givers.
- Compare events flagged as falls by system algorithms with the fall log produced by Garrison staff, cross-verified against personal fall logs, to determine the ability of the system to detect falls.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Wireless Body-Worn Sensors
Elderly patients will wear sensors (Smart Slippers and a belt-clip sensor) as they go about their daily life in a geriatric care center.
Device: Smart Slipper
The shoe measures foot pressure and motion allowing gait to be quantified.
Device: Belt-Clip Sensor
The sensor measures acceleration of the body allowing falls to be detected.
- Detection of Fall Incidences [ Time Frame: 6 months ]Participants will be monitored for falls. The detection of fall events as determined by the sensors will be compared to the fall log kept by Garrison Geriatric Center.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272933
|Contact: Tim Dallas, PhDfirstname.lastname@example.org|
|Contact: Ron Banister, MDemail@example.com|
|United States, Texas|
|Garrison Geriatric Education and Care Center||Recruiting|
|Lubbock, Texas, United States, 79415|
|Contact: Wendy Grimes, MSN-RN 806-763-4455 firstname.lastname@example.org|
|Contact: Barbara Bratcher, MSN-RN 806-763-4455 email@example.com|
|Principal Investigator:||Ron Banister, MD||Texas Tech University Health Sciences Center|