Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396676
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-04-23
Brief Title:
SHIFT-Hospital in Motion Validation Study
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
SHIFT-Hospital in Motion Validation Study of a Newly Developed Algorithm for Movement Detection Using Activity Sensors in Acute Care Hospital Patients
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this monocentric observational study involving acute hospitalised patients is to validate the accuracy of classification algorithms for the detection of various movements parameters
Detailed Description:
Patients in hospitals spend the majority of their time inactive sitting or lying down Not being active is a common problem for patients in hospitals often causing complications and impairing recovery as it can lead to issues such as reduced blood volume unsteady blood pressure when standing weaker muscles and a higher risk of infections blood clots and other health issues The inactivity-related changes in the body in combination with the natural ageing process the stress of being in the hospital a poor nutritional status and possibly troubles with thinking memory and understanding or depression diminish the ability to regenerate with overall compromised physiological resilience
In order to quantify the amount of physical activity of hospitalised patients the ability of activity sensors to distinguish between lying sitting standing and walking is an important requirement A pilot study NCT06403826 involving 40 patients examined the feasibility and effectiveness of using activity sensors in clinical settings The study focused on detecting specific activities and movement patterns using sensors worn on various body parts with the ankle identified as the preferred location for long-term monitoring Most participants found wearing the sensors tolerable indicating the practicality of this approach for extended patient activity monitoring
The primary objective of this observational single center study is to validate the accuracy of newly developed algorithms for the detection of various movements parameters Two different sensors worn on the ankle are used to record the duration of lying sittingstanding and the number of steps taken when walking and climbing stairs updown The validation is based on the movement data collected from this and the pilot study and will be conducted in two phases
phase 1 model improvement Increasing the robustness of the algorithms using training data
phase 2 model validation Validation of the algorithms using test data
The secondary objectives are
to determine if altitude data enhances the algorithms accuracy in distinguishing between stair climbing and walking
to evaluate the comfort of wearing the sensors
The results of this study will advance healthcare by developing an algorithm that accurately determines the activity patterns of hospitalized patients thereby enhancing monitoring and understanding of patient mobility in hospital settings
In order to quantify the amount of physical activity of hospitalised patients the ability of activity sensors to distinguish between lying sitting standing and walking is an important requirement A pilot study NCT06403826 involving 40 patients examined the feasibility and effectiveness of using activity sensors in clinical settings The study focused on detecting specific activities and movement patterns using sensors worn on various body parts with the ankle identified as the preferred location for long-term monitoring Most participants found wearing the sensors tolerable indicating the practicality of this approach for extended patient activity monitoring
The primary objective of this observational single center study is to validate the accuracy of newly developed algorithms for the detection of various movements parameters Two different sensors worn on the ankle are used to record the duration of lying sittingstanding and the number of steps taken when walking and climbing stairs updown The validation is based on the movement data collected from this and the pilot study and will be conducted in two phases
phase 1 model improvement Increasing the robustness of the algorithms using training data
phase 2 model validation Validation of the algorithms using test data
The secondary objectives are
to determine if altitude data enhances the algorithms accuracy in distinguishing between stair climbing and walking
to evaluate the comfort of wearing the sensors
The results of this study will advance healthcare by developing an algorithm that accurately determines the activity patterns of hospitalized patients thereby enhancing monitoring and understanding of patient mobility in hospital settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None