Hospitalized PatientsNCT06396676
SHIFT-Hospital in Motion (Validation Study)
An observational study of Hospitalized Patients and Physical Inactivity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Patients, Physical Inactivity
- How many people
- 101 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Apr 2024to 22 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute hospitalized patients are continuously recruited by the project management team within the context of daily clinical practice from both medical and surgical wards at the University Hospital Basel. Recruitment takes place as soon as possible after admission to the hospital.
Who may be able to join
- patient must have been able to walk before hospitalisation (with or without aids)
- patient must be cognitively able to follow instructions (if a cognitive assessment has been carried out, this cut-off value counts, if no assessment is available, no cognitive impairment is assumed)
- ≥ 18 years
- signed informed consent
Who cannot join
- patient unable to move prior to hospital admission
- prior inclusion in the study
- discharge on the same day
- inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders (such as Parkinsonism, hemiplegia, severe Multiple Sclerosis), speech problems, mental disorders, or cognitive impairments
- isolated patient (unable to complete the test battery completely)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitiy Hospital Basel, Division of Internal Medicine
Basel, Canton of Basel-City, 4031
About this study
Official title: SHIFT-Hospital in Motion: Validation Study of a Newly Developed Algorithm for Movement Detection Using Activity Sensors in Acute Care Hospital Patients
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.
Read the 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, sitting/standing, and the number of steps taken when walking and climbing stairs (up/down). 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.
- Conditions
- Hospitalized Patients, Physical Inactivity
- Keywords
- Movement detection, Activity sensors, Algorithm development and validation
- Medical subject headings
- Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the accuracy of the classification algorithm for the detection of movements parameters
During both study phases, patient movement is recorded using two sensors on the non-affected/dominant ankle side. Lower extremities are filmed for precise data annotation.
In phase 1 (model improvement), patients undergo a test battery to improve the accuracy of the algorithm developed in the pilot study for motion and activity detection. The test battery contains a fixed sequence of movements, including lying, sitting, standing, walking and stair climbing.
In phase 2 (model validation), a less restrictive test battery is used to validate algorithm accuracy. Patients perform movements like lying, sitting, standing, walking, and stair climbing for up to 15 minutes. Sequence and duration are not predefined.
Algorithm accuracy is assessed via a multi-class confusion matrix. Rows show actual classes, columns show predicted classes. The diagonal contains observations where predicted matches actual (true positive). Accuracy [%]= (Sum of diagonal elements/Total observations)*100.
Measured: during hospitalization (up to 1 hour)
Secondary outcomes (2)
Comparison of the accuracy of the algorithm with and without the use of altimeter data
In this study two different sensors are used. One of these sensors records altimeter data in addition to gyroscope and accelerometer data. The aim of the comparison is to determine if the altimeter data improves the algorithm' accuracy in distinguishing between stair climbing and walking.
The accuracy of the algorithm is calculated using a multi-class confusion matrix. The rows are the actual classes and the columns are the predicted classes. The diagonal of the matrix contains the observations where the predicted class matches the actual class (true positive). Accuracy [in %]= Sum of the diagonal elements / Total number of observations * 100. At the end, the accuracy of the algorithm with and without the use of altimeter data is compared.
Measured: during hospitalization (up to 1 hour)
Assessment of the comfort level associated with wearing the sensors
The comfort of wearing the sensors is evaluated after both study phases by a questionnaire. The responses from patients are being collected regarding the discomfort of wearing the sensors or any problems with the attachment.
Measured: during hospitalization (up to 10 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start29 Apr 2024
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Zurich University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Joris Kirchberger, Principal investigator, University Hospital, Basel, SwitzerlandJens Eckstein, Prof. Dr. med., Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396676
- Sponsor's protocol ID
- 2024-00594; am24Eckstein
- Status last verified
- Jul 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHIFT-Hospital in Motion: Validation Study of a Newly Developed Algorithm for Movement Detection Using Activity Sensors in Acute Care Hospital Patients
- ClinicalTrials.gov ID
- NCT06396676
- Acronym / sponsor ID
- 2024-00594; am24Eckstein
- Conditions
- Hospitalized Patients, Physical Inactivity
- Keywords
- Movement detection, Activity sensors, Algorithm development and validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Zurich University of Applied Sciences
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, sitting/standing, and the number of steps taken when walking and climbing stairs (up/down). 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute hospitalized patients are continuously recruited by the project management team within the context of daily clinical practice from both medical and surgical wards at the University Hospital Basel. Recruitment takes place as soon as possible after admission to the hospital.
Key inclusion criteria (4 listed)
- patient must have been able to walk before hospitalisation (with or without aids)
- patient must be cognitively able to follow instructions (if a cognitive assessment has been carried out, this cut-off value counts, if no assessment is available, no cognitive impairment is assumed)
- ≥ 18 years
- signed informed consent
Key exclusion criteria (5 listed)
- patient unable to move prior to hospital admission
- prior inclusion in the study
- discharge on the same day
- inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders (such as Parkinsonism, hemiplegia, severe Multiple Sclerosis), speech problems, mental disorders, or cognitive impairments
- isolated patient (unable to complete the test battery completely)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the accuracy of the classification algorithm for the detection of movements parameters
Time frame: during hospitalization (up to 1 hour)
During both study phases, patient movement is recorded using two sensors on the non-affected/dominant ankle side. Lower extremities are filmed for precise data annotation. In phase 1 (model improvement), patients undergo a test battery to improve the accuracy of the algorithm developed in the pilot study for motion and activity detection. The test battery contains a fixed sequence of movements, including lying, sitting, standing, walking and stair climbing. In phase 2 (model validation), a less restrictive test battery is used to validate algorithm accuracy. Patients perform movements like lying, sitting, standing, walking, and stair climbing for up to 15 minutes. Sequence and duration are not predefined. Algorithm accuracy is assessed via a multi-class confusion matrix. Rows show actual classes, columns show predicted classes. The diagonal contains observations where predicted matches actual (true positive). Accuracy [%]= (Sum of diagonal elements/Total observations)*100.
2 secondary outcomes
Comparison of the accuracy of the algorithm with and without the use of altimeter data
Time frame: during hospitalization (up to 1 hour)
Assessment of the comfort level associated with wearing the sensors
Time frame: during hospitalization (up to 10 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Kirchberger principal investigator
University Hospital, Basel, Switzerland
Jens Eckstein, Prof. Dr. med. study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Patients and Physical Inactivity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the accuracy of the classification algorithm for the detection of movements parameters (time frame: during hospitalization (up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.