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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Muscle Weakness Acquired Weakness Critical Illness Critical Illness Recovery Disease Attributes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas

Pieve Emanuele, Milano, 20072, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Scale validity

Time frame: 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

Time frame: 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.

Secondary outcomes

Predictive validity

Time frame: From June 2023 to June 2025

Correlation between IMS-it and clinical outcomes will be assessed, and adjusted through a multivariable logistic regression model.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Sep 29, 2025
Registry last updated: Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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