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

NCT07195942 | Active Not Recruiting

• 1 other identifier: IMS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Early Mobilisation; Muscle Weakness; Critical Illness; Acquired Weakness; Functional Mobility; Validation study; Inter-rater reliability

Outcome Measures

Primary Outcomes (2)

• Scale validity

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

  From June 2023 to June 2025

• Inter-rater reliability

  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.

  From June 2023 to June 2025

Secondary Outcomes (1)

• Predictive validity

  From June 2023 to June 2025

Eligibility Criteria

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

Study Population

Adult patients admitted to the General Intensive Care Unit (GICU) at the Humanitas Clinical Institute in Rozzano (MI)

You may qualify if:

• patients aged ≥ 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Pieve Emanuele, Milano, 20072, Italy

Location

MeSH Terms

Conditions

Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes

Study Officials

• Massimiliano Greco, Anaesthesia and Intensive Care

  Istituto Clinico Humanitas

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: June 22, 2023
• Primary Completion: May 20, 2025
• Study Completion: November 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

IT (1)