SHIFT-Hospital in Motion (Validation Study)

NCT06396676 | Completed

• 1 other identifier: 2024-00594; am24Eckstein
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalized Patients; Physical Inactivity

Keywords

Movement detection; Activity sensors; Algorithm development and validation

Outcome Measures

Primary Outcomes (1)

• 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.

  during hospitalization (up to 1 hour)

Secondary Outcomes (2)

• Comparison of the accuracy of the algorithm with and without the use of altimeter data

  during hospitalization (up to 1 hour)

• Assessment of the comfort level associated with wearing the sensors

  during hospitalization (up to 10 min)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• patient unable to move prior to hospital admission
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Zurich University of Applied Sciences: collaborator

Study Sites (1)

Universitiy Hospital Basel, Division of Internal Medicine

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joris Kirchberger

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Jens Eckstein, Prof. Dr. med.

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 2, 2024
• Study Start: April 29, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CH (1)