The main objective of this study is to validate the accuracy of the device to monitor the physical activity of a subject by comparing the measured values to the golden standard (video recording).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the bias and precision of total time spend on one
activity/posture (per activity/posture), number of steps, number of
transitions, motion intensity, and main activity per minute as determined by
the device under test compared to the golden standard. The activities and
postures that can be discriminated between are lying, standing/sitting,
walking, stair walking, and bending.
Secondary outcome
N/A
Background summary
Low physical activity is common during hospital stays. It has been shown that
this can increase hospital-related complications and that it can be associated
with functional decline after discharge of the hospital. Healthcare
professionals can stimulate patients to be more physical active. To provide
healthcare professionals with an objective method to monitor physical activity
in the hospital, FastFocus developed its second generation of a wireless
monitoring system, the Vital Signs Monitoring System. This wearable device
combines physical activity monitoring with the monitoring of vital signs (pulse
rate, respiratory rate, and oxygen saturation) and is, therefore, feasible to
be used on ambulant patients in a healthcare environment. We want to validate
the accuracy of the Vital Signs Monitoring System in monitoring the various
parameters related to physical activity, which are based on accelerometry. This
is essential to assure its accuracy before bringing the device to the market.
Study objective
The main objective of this study is to validate the accuracy of the device to
monitor the physical activity of a subject by comparing the measured values to
the golden standard (video recording).
Study design
This study is a method-comparison study in a controlled environment. Healthy
volunteers will perform different prescribed activities for approximately 20
minutes while being monitored by two different methods.
Study burden and risks
The hardware that is used is identical to the first-generation wireless
monitoring system of FastFocus, Wireless Patient Monitoring System, that is CE
marked as a medical device. Activities that must be performed by the subject
are normal day activities, like sitting and walking. The subject needs to spend
about 30 minutes to participate in the study. Hence, it is concluded that the
risk and burden for the subject are negligible.
Gerverscop 9
Harmelen 3481LT
NL
Gerverscop 9
Harmelen 3481LT
NL
Listed location countries
Age
Inclusion criteria
Adult (> 18 years)
Physically able to perform the specified activities
Exclusion criteria
Inability to give informed consent
Pregnant or breastfeeding
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL78761.000.21 |