Development of the Italian Version of the ICU Mobility Scale (IMS). Cross-cultural Adaptation, It… (NCT07195942) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Development of the Italian Version of the ICU Mobility Scale (IMS). Cross-cultural Adaptation, Italian Translation, and Validation Study.
Italy100 participantsStarted 2023-06-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is about validating an Italian version of a mobility scale used in the ICU — does that mean my participation would involve being observed and scored on my ability to move, rather than receiving any new treatment or medication?
2Since this is a validation study measuring how reliably two different raters score the same patient's mobility, what would actually be asked of me or my family member during participation, and how much time or physical effort would it involve?
3Given that this study is about developing a measurement tool rather than testing a therapy, would taking part in it have any direct benefit for my current treatment or recovery from critical illness weakness, or is it purely to help future patients?
4The trial is currently active but no longer recruiting — does that mean there is no possibility of joining, and if so, what other options exist for monitoring and addressing muscle weakness in the ICU setting?
5Since acquired weakness after critical illness can have long-term effects, what standard approaches are already available to assess and treat my mobility issues, and how does this type of validated scale fit into the care I might receive now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.