Muscle WeaknessNCT07195942
Development of the Italian Version of the ICU Mobility Scale (IMS). Cross-cultural Adaptation, Italian Translation, and Validation Study.
An observational study of Muscle Weakness and Critical Illness, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Critical Illness, Critical Illness Recovery
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2023to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the General Intensive Care Unit (GICU) at the Humanitas Clinical Institute in Rozzano (MI)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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.
- Keywords
- Early Mobilisation, Muscle Weakness, Critical Illness, Acquired Weakness, Functional Mobility, Validation study, Inter-rater reliability
- Medical subject headings
- Muscle Weakness, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale validity
The correlation between IMS and other scales of muscular strength will be assessed using spearman correlation
Measured: 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.
Measured: From June 2023 to June 2025
Secondary outcomes (1)
Predictive validity
Correlation between IMS-it and clinical outcomes will be assessed, and adjusted through a multivariable logistic regression model.
Measured: From June 2023 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start22 Jun 2023
- Primary completion20 May 2025
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimiliano Greco, Anaesthesia and Intensive Care, Study director, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195942
- Sponsor's protocol ID
- IMS
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Italian Version of the ICU Mobility Scale (IMS). Cross-cultural Adaptation, Italian Translation, and Validation Study.
- ClinicalTrials.gov ID
- NCT07195942
- Acronym / sponsor ID
- IMS
- Keywords
- Early Mobilisation, Muscle Weakness, Critical Illness, Acquired Weakness, Functional Mobility, Validation study, Inter-rater reliability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the General Intensive Care Unit (GICU) at the Humanitas Clinical Institute in Rozzano (MI)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Predictive validity
Time frame: From June 2023 to June 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimiliano Greco, Anaesthesia and Intensive Care study director
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness and Critical Illness, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale validity (time frame: From June 2023 to June 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.