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临床试验/NCT07195942
NCT07195942进行中(未招募)不适用

Development of the Italian Version of the ICU Mobility Scale (IMS). Cross-cultural Adaptation, Italian Translation, and Validation Study.

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Scale validity

研究概览

简要总结

Early mobilisation of the patient admitted to intensive care units (ICUs) is essential to prevent Intensive Care Unit Acquired Weakness (ICUAW). It is essential to be able to measure functional mobility in order to evaluate the effectiveness of early mobilisation, both in clinical and research settings.

The ICU Mobility Scale (IMS) is a validated scale that can be used to describe the functional level of the critically ill patient according to a categorical scale of 11 items. Each category describes the patient's capabilities from a mobility point of view.

The main objective of the study is the validation of the Italian version of the IMS (IMS-it) on a cohort of patients admitted to intensive care.

Secondary objective is to assess the concordance between the perception level that the healthcare worker has with regard to the patient's mobility, before the patient is mobilised, expressed with the IMSSecondary study objectives.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients aged ≥ 18 years
  • •ability self-mobility prior to hospital admission (assessed by the Clinical Frailty Scale), if applicable, the reasons for inclusion of vulnerable patients.

排除标准

  • •Concurrent admission due to newly diagnosed or suspected neurological disorders (e.g., stroke, intracranial hemorrhages, head trauma, Guillain-Barré syndrome, status epilepticus)
  • •Primary neurological or myopathic processes associated with muscle weakness (e.g. Guillain-Barré syndrome)
  • •Inability to understand and speak Italian
  • •History of cognitive deficits before hospital admission
  • •Unstable fractures or traumas requiring immobility, mobility restrictions, or bed rest
  • •Terminally ill patients in palliative care
  • •Any other clinical reasons that may prevent patient mobilization according to caring physician.

结局指标

主要结局

Scale validity

时间窗: From June 2023 to June 2025

The correlation between IMS and other scales of muscular strength will be assessed using spearman correlation

Inter-rater reliability

时间窗: From June 2023 to June 2025

During the daily treatment of the patients by a healthcare professional, 1 critical care physiotherapist, 1 non-critical care physiotherapist and 1 critical care nurse will assess the patients enrolled in the study by means of the IMS.

次要结局

  • Predictive validity(From June 2023 to June 2025)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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