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Studies

Observational Active not recruiting

NCT07195942 on ClinicalTrials.gov

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

  • Sponsor: IRCCS Humanitas Research Hospital
  • Enrollment: 100 (Actual)
  • Study start: 2023-06-22 (Actual)
  • Primary completion: 2025-05-20 (Actual)
  • Study completion: 2025-11-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • Muscle Weakness
  • Critical Illness
  • Critical Illness Recovery
  • Acquired Weakness

Primary Outcome Measures

  • Scale validity (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 (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.

Countries

Italy

Locations and Investigators

  • Istituto Clinico Humanitas, Pieve Emanuele, Italy

Study Officials