To assess the concurrent validity of the FastFocus* Vital Sign Monitoring System classification algorithm that discriminates between lying, sitting/standing, and walking activities, and detects number of walking steps in hospitalised patients under…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patiënten met problemen met bewegend functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter: total time walking (sec.).
Secondary outcome
Secondary outcome parameters: total time sitting/standing (sec.), total time
lying (sec.), total number of steps (n).
Background summary
Low amounts of physical activity and prolonged periods of sedentary activity are
common in hospitalised patients. Objective physical activity monitoring is
needed to prevent the negative effects of inactivity. FastFocus has developed a
wireless monitoring system (ear sensor), the Vital Signs Monitoring System.
This wearable device combines physical activity monitoring with the monitoring
of vital signs and is feasible to be used on ambulant patients in a healthcare
environment. However, the Vital Sign Monitoring System has not been validated
to discriminate between lying, sitting/standing, and walking activities, and
detects number of walking steps in hospitalised patients under free living
conditions yet.
Study objective
To assess the concurrent validity of the FastFocus* Vital Sign Monitoring
System classification algorithm that discriminates between lying,
sitting/standing, and walking activities, and detects number of walking steps
in hospitalised patients under free living conditions by checking it against
video analysis.
Study design
This single centre, prospective validation study will take place from May 2023
until October 2023 at the department of Physiotherapy at the Maastricht
University Medical Centre (MUMC+).
Study burden and risks
The burden and risks of participation in this study are minimal. Wearing the
Vital Signs Monitoring System ear sensor should not be a burden to patients.
Patients will be informed that they can take the activity monitor off in case
they are bothered in any way. Patients and healthcare professionals will be
instructed to remove the activity monitor in case of skin irritation or damage.
The measurement will be performed during usual care physiotherapy.
Participation in the study will take approximately 25 minutes, including the
informed consent process, attaching and removing the ear sensor.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Receiving physiotherapy treatment during hospitalisation at the MUMC+
- 18 years or older
- Able to walk
- Willing to participate
- Sufficient understanding of the Dutch language
- Able to provide written informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Admitted to the Intensive Care or Medium Care units.
- A contraindication concerning walking (as reported by the attending medical
specialists in the medical record).
- A contraindication to wearing the FastFocus* Vital Signs Monitoring System
activity monitor at the ear (i.e.: patients with signs of skin damage on the
ear, patients with pierced ears at the sensor application/measurement site,
patients with skin conditions that could result in permanent harm when using
the EarSensor, patients with limited blood perfusion through the ear due to
medical conditions (e.g., cauliflower ears, ischemic ear shells, etc.),
patients that are obliged to wear other medical devices for health and/or
disability purposes (e.g., hearing aids, oxygen tubes, etc.), and/or patients
in which the inner aspect of the ear (cavum conchae) is not large enough to
accommodate the hook of the sensor without touching the tragus and/or crus of
helix.)
- Impaired cognition (dementia / delirium) as reported by the attending medical
specialist in the medical record.
- Incapacitated subjects as reported by the attending medical specialist in the
medical record. When any doubt arises, the patient will not be considered
eligible
- A life expectancy shorter than 3 months as mentioned by the attending medical
specialist in the medical record
- Subjects that are not allowed to leave their hospital room due to isolation
measures as reported in the medical record.
- Pregnant or breastfeeding women.
- Inability to give informed consent.
- Previous participation in this study.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL82226.000.22 |