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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07195942

Enrollment

100

Registered

2025-09-29

Start date

2023-06-22

Completion date

2025-11-30

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Weakness, Critical Illness, Critical Illness Recovery, Muscle Weakness

Keywords

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Predictive validity	From June 2023 to June 2025	Correlation between IMS-it and clinical outcomes will be assessed, and adjusted through a multivariable logistic regression model.

Countries

Italy

Outcome results