Muscle WeaknessTAVIMSNCT05591950
Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)
An observational study of Muscle Weakness and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Critical Illness, Mechanical Ventilation Complication
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2023to 20 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study includes intensive care patients who are treated by the Clinic for Anesthesiology with focus on surgical intensive care medicine at the Charité - Universitätsmedizin Berlin for an expected period of more than 24 hours, who are at least 18 years old and receive ventilation support.
Who may be able to join
- Critically ill adults (age: ≥ 18 years)
- Expected length of stay in ICU > 24h
- Ventilation support
Who cannot join
- Patients transferred from other ICUs
- Patients with pre-existing functional limitations
- Patients with functional limitations due to the admission diagnosis (e.g. stroke. with hemiparesis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Univiversitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Übersetzung Und Validierung Einer Deutschen Version Der Intensive Care Unit Mobility Scale (IMS) Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)
Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS).
The subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care.
- Conditions
- Muscle Weakness, Critical Illness, Mechanical Ventilation Complication, Early Mobilization
- Keywords
- ICU-mobility-scale
- Medical subject headings
- Muscle Weakness, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive validity of the IMS
Predictive validity of the IMS-score performed in the first 24 hours after admission to the ICU for the length of stay in the ICU
Measured: approximate 28 days (till ICU discharge)
Secondary outcomes (11)
ICU mortality
Mortality during ICU stay
Measured: approximate 28 days (till ICU discharge)
Duration of mechanical ventilation
Duration of invasive mechanical ventilator dependency
Measured: approximate 28 days (till ICU discharge)
Discharge location
If the patient was discharged home or to another facility at hospital discharge
Measured: approximate at 28 days (at hospital discharge)
MRC Score
Muscle strength at ICU discharge measured using the Medical Research Council score
Measured: approximate 28 days (till ICU discharge)
Muscle strength
Muscle strength at ICU discharge measured using hand grip strength
Measured: approximate 28 days (till ICU discharge)
90-day mortality
Mortality at 90 days
Measured: at 90 days
90-day function
Physical function of the patient at 90 days
Measured: at 90 days
IMS during the ICU stay
achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)
Measured: approximate 28 days (till ICU discharge)
ICU-LOS
Length of stay in the ICU
Measured: approximate 28 days (till ICU discharge)
Hospital LOS
Length of stay in the hospital
Measured: approximate 28 days (till discharge)
in-hospital mortality
Mortality during the Hospital stay
Measured: approximate 28 days (till discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start24 Jan 2023
- Primary completion11 Nov 2024
- Study completion20 Feb 2025
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 Charite University, Berlin, GermanyThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan J Schaller, Charite University, Berlin, Germany
- Investigators
- Stefan J Schaller, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591950
- Sponsor's protocol ID
- TAVIMS
- Acronym
- TAVIMS
- Status last verified
- Apr 2025
- First submitted
- 17 Aug 2022
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be requested on reasonable scientific request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Übersetzung Und Validierung Einer Deutschen Version Der Intensive Care Unit Mobility Scale (IMS) Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)
- ClinicalTrials.gov ID
- NCT05591950
- Acronym / sponsor ID
- TAVIMS / TAVIMS
- Conditions
- Muscle Weakness, Critical Illness, Mechanical Ventilation Complication, Early Mobilization
- Keywords
- ICU-mobility-scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 24 Oct 2022 (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.
Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS).
The subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes intensive care patients who are treated by the Clinic for Anesthesiology with focus on surgical intensive care medicine at the Charité - Universitätsmedizin Berlin for an expected period of more than 24 hours, who are at least 18 years old and receive ventilation support.
Key inclusion criteria (3 listed)
- Critically ill adults (age: ≥ 18 years)
- Expected length of stay in ICU > 24h
- Ventilation support
Key exclusion criteria (3 listed)
- Patients transferred from other ICUs
- Patients with pre-existing functional limitations
- Patients with functional limitations due to the admission diagnosis (e.g. stroke. with hemiparesis)
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
Predictive validity of the IMS
Time frame: approximate 28 days (till ICU discharge)
Predictive validity of the IMS-score performed in the first 24 hours after admission to the ICU for the length of stay in the ICU
11 secondary outcomes
ICU mortality
Time frame: approximate 28 days (till ICU discharge)
Duration of mechanical ventilation
Time frame: approximate 28 days (till ICU discharge)
Discharge location
Time frame: approximate at 28 days (at hospital discharge)
MRC Score
Time frame: approximate 28 days (till ICU discharge)
Muscle strength
Time frame: approximate 28 days (till ICU discharge)
90-day mortality
Time frame: at 90 days
90-day function
Time frame: at 90 days
IMS during the ICU stay
Time frame: approximate 28 days (till ICU discharge)
ICU-LOS
Time frame: approximate 28 days (till ICU discharge)
Hospital LOS
Time frame: approximate 28 days (till discharge)
in-hospital mortality
Time frame: approximate 28 days (till discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. Deidentified data can be requested on reasonable scientific request.
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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.
Stefan J Schaller, MD principal investigator
Charite University, Berlin, Germany
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 Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Apr 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictive validity of the IMS (time frame: approximate 28 days (till ICU discharge)). 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 24 Apr 2025.