Critical Illness PolyneuromyopathyROBEM-INCT04423796
Robotic Assisted Early Mobilization in Ventilated ICU Patients
A study testing Robotic-assisted early mobilization and Early mobilization in people with Critical Illness Polyneuromyopathy and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Polyneuromyopathy, Critical Illness, Early Ambulation
- What is being tested?
- Robotic-assisted early mobilization and Early mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 13 Nov 2020to 12 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Invasive mechanically ventilated and expected to be ventilated for another 24 hours
- Cardiovascular stability, allowing mobilization
- Respiratory stability, allowing mobilization
Who cannot join
- Bed-bound before ICU admission
- Bed-rest order or contraindication of weight load of the lower extremity or spine
- Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
- Fresh SAB, ICB or elevated ICP
- Status epilepticus
- Acute intoxication
Show all 19Show fewer
- Shock with catecholamine doses >0.3µg/kg/min or acute bleeding including organ ruptures
- Multiorgan failure with lactate > 4 mmol/l
- Body height outside the range 150-195 cm
- Body weight outside the range 45-135 kg
- pAVK IV°
- Pacemakers or other electrical stimulators
- Implanted medical pumps
- Pregnancy
- Life expectancy below 7 days or acute palliative care situation
- Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request
- Unable to understand the official language
- ICU stay > 72h at the time of enrolment
- Translated with www.DeepL.com/Translator (free version)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Univiversitätsmedizin Berlin
Mitte, State of Berlin, 10117
About this study
Official title: Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.
- Being tested
- Robotic-assisted early mobilization, Early mobilization
- Keywords
- Early mobilization, pilot trial, feasibility trial, robotic assisted
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted early mobilizationDevice
The early mobilization is done by robotic assistance devices.
Early mobilizationOther
Early mobilization by health care professionals without robotic assistance.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted early mobilization | Experimental | Robotic assisted early mobilization started within 72 hours of ICU admission. Receives: Device: Robotic-assisted early mobilization |
| Early mobilization | Active comparator | Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell. Receives: Other: Early mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of early mobilization
Frequency of early mobilization performed by one health care provider during mechanical ventilation
Measured: Up to Day 5
Secondary outcomes (12)
Mobilization level
Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10
Measured: up to Day 5
Mobilization duration
Duration of mobilzation sessions during mechanical ventilation
Measured: up to Day 5
Frequency of mobilization
Frequency of early mobilization during mechanical ventilation
Measured: up to Day 5
Pain level
Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12
Measured: up to Day 5
Anxiety
Anxiety due to mobilization using a numerical scale (NRS 0-10)
Measured: up to Day 5
Patient satisfaction with mobilization
Satisfaction with mobilization using a numerical scale (NRS 0-10)
Measured: Up to Day 5
Inflammatory response
Zytokin change from before to after mobilization
Measured: Up to Day 5
Health care provider assessment
Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)
Measured: Up to Day 5
Muscle wasting
Muscle wasting will be assessed using ultrasound measurement of the M. femoris
Measured: Up to Day5
Oxygen consumption during mobilization
Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization
Measured: Up to Day 5
Oesophageal pressure
Oesophageal pressure will be measured during mobilization
Measured: Up to Day 5
Safety events
Frequency of safety events during mobilization
Measured: Up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start13 Nov 2020
- Primary completion14 Aug 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Illness PolyneuromyopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel-group, open label pilot trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Reactive Robotics GmbH
- 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
- NCT04423796
- Sponsor's protocol ID
- ROBEM I
- Acronym
- ROBEM-I
- Status last verified
- Sep 2023
- First submitted
- 6 Jun 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data can be requested from the PI after publication of the study for scientific purpose.
Publications
Lorenz M, Langer N, Kloss P, Maechler M, Bald A, Warner L, Fuest K, Weiss B, Schaller SJ. ROBotic-assisted Early Mobilization in ventilated surgical critically ill patients (ROBEM-I)-A randomized, controlled, outcome-assessor-blinded pilot study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101549. doi: 10.1016/j.accpm.2025.101549. Epub 2025 May 23.
PubMed 40414562
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT04423796
- Acronym / sponsor ID
- ROBEM-I / ROBEM I
- Keywords
- Early mobilization, pilot trial, feasibility trial, robotic assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Reactive Robotics GmbH
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 9 Jun 2020 (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.
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel-group, open label pilot trial
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted early mobilization | Experimental | Device: Robotic-assisted early mobilizationRobotic assisted early mobilization started within 72 hours of ICU admission. |
| Early mobilization | Active comparator | Other: Early mobilizationEarly mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Invasive mechanically ventilated and expected to be ventilated for another 24 hours
- Cardiovascular stability, allowing mobilization
- Respiratory stability, allowing mobilization
Key exclusion criteria (19 listed)
- Bed-bound before ICU admission
- Bed-rest order or contraindication of weight load of the lower extremity or spine
- Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
- Fresh SAB, ICB or elevated ICP
- Status epilepticus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted early mobilizationThe early mobilization is done by robotic assistance devices. | Device | Robotic assisted early mobilization |
| Early mobilizationEarly mobilization by health care professionals without robotic assistance. | Other | Early mobilization |
Primary outcome
Feasibility of early mobilization
Time frame: Up to Day 5
Frequency of early mobilization performed by one health care provider during mechanical ventilation
12 secondary outcomes
Mobilization level
Time frame: up to Day 5
Mobilization duration
Time frame: up to Day 5
Frequency of mobilization
Time frame: up to Day 5
Pain level
Time frame: up to Day 5
Anxiety
Time frame: up to Day 5
Patient satisfaction with mobilization
Time frame: Up to Day 5
Inflammatory response
Time frame: Up to Day 5
Health care provider assessment
Time frame: Up to Day 5
Muscle wasting
Time frame: Up to Day5
Oxygen consumption during mobilization
Time frame: Up to Day 5
Oesophageal pressure
Time frame: Up to Day 5
Safety events
Time frame: Up to Day 5
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 8 Sep 2023.
- Derived from this study: PubMed 40414562Lorenz M, Langer N, Kloss P, Maechler M, Bald A, Warner L, Fuest K, Weiss B, Schaller SJ. ROBotic-assisted Early Mobilization in ventilated surgical critically ill patients (ROBEM-I)-A randomized, controlled, outcome-assessor-blinded pilot study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101549. doi: 10.1016/j.accpm.2025.101549. Epub 2025 May 23.
- Individual participant dataSharing planned: Yes. Anonymized data can be requested from the PI after publication of the study for scientific purpose.
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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?
A study testing Robotic-assisted early mobilization and Early mobilization in people with Critical Illness Polyneuromyopathy 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 4 inclusion and 19 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 8 Sep 2023. 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?
Feasibility of early mobilization (time frame: Up to Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423796, which also lists 1 linked publication.
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 8 Sep 2023.