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临床试验/NCT06396676
NCT06396676
已完成
不适用

SHIFT-Hospital in Motion: Validation Study of a Newly Developed Algorithm for Movement Detection Using Activity Sensors in Acute Care Hospital Patients

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 101 人2024年4月29日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Hospitalized Patients
发起方
University Hospital, Basel, Switzerland
入组人数
101
试验地点
1
主要终点
Assessment of the accuracy of the classification algorithm for the detection of movements parameters
状态
已完成
最后更新
去年

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年4月29日
结束日期
2024年7月22日
最后更新
去年
研究类型
Observational
性别
All

研究者

发起方
University Hospital, Basel, Switzerland
责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Assessment of the accuracy of the classification algorithm for the detection of movements parameters

时间窗: 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.

次要结局

  • Assessment of the comfort level associated with wearing the sensors(during hospitalization (up to 10 min))
  • Comparison of the accuracy of the algorithm with and without the use of altimeter data(during hospitalization (up to 1 hour))

研究点 (1)

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