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NCT02835248 Clinical Trial

A Novel System to Detect Falls in Real-life Conditions

Falls Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02835248
Other study ID # 15-0930-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date May 2018

Study information
Verified date July 2018
Source BioSensics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. In this project, the sensitivity and false alarm rate of a commercially available medical alert device will be tested in a population of 200 community-dwelling older adults.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).

Exclusion Criteria:

- Uses a medical alert device

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Fall Detection
All participants will wear a device configured to detect falls.

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
BioSensics Brigham and Women's Hospital, Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The sensitivity and specificity of ActivePERS fall detection algorithms will be measured by comparing the occurence of falls detected by the wearable device to study participant self reported falls 2 years
Secondary Near falls as measured by patient self report 2 years
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