Covid19NCT04750265
Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19
A study testing Robotic assisted early mobilization in people with Covid19 and Critical Illness, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, Critical Illness, Critical Illness Polyneuromyopathy
- What is being tested?
- Robotic assisted early mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2021to 3 Feb 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 to 100 years
- 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 17Show 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
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 With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
- Conditions
- Covid19, Critical Illness, Critical Illness Polyneuromyopathy, Early Mobilization, Rehabilitation, Robotics
- Being tested
- Robotic assisted early mobilization
- Keywords
- COVID19, Early mobilization, robotics, Vemo
- Medical subject headings
- COVID-19, 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
Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted early mobilization | Experimental | Early mobilization therapy assisted with robotics Receives: Device: Robotic assisted early mobilization |
| Standard Care | No intervention | Mobilization according to standard care by staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of mobilization
Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)
Measured: 5 days
Level of mobilization
Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)
Measured: 5 days
Secondary outcomes (18)
Frequency of Mobilization
Frequency of early mobilization during mechanical ventilation
Measured: 5 days
Initiation of first Mobilization
Time of first mobilization after admission on ICU (in hours)
Measured: 5 days
Mobilization duration
Average duration of mobilization sessions during mechanical ventilation (in min)
Measured: 5 days
Depth of sedation
Depth of sedation measured with RASS during the first 5 days after admission on ICU
Measured: 5 days
Days of sedation
Days under sedative medication during ICU stay
Measured: during ICU stay (normally up to 30 days)
Days of mechanical ventilation
Days of mechanical ventilation during ICU stay
Measured: during ICU stay (normally up to 30 days)
Days of Intubation
Days of Intubation during ICU stay
Measured: during ICU stay (normally up to 30 days)
Days of Delirium
Days of Delirium during ICU stay
Measured: during ICU stay (normally up to 30 days)
MRC Score
MRC Score at ICU Discharge
Measured: One time point before ICU Discharge
Muscle wasting
Muscle wasting assessed using ultrasound measurement of the M. femoris
Measured: 5 days
Number of Health care provider
Number of Health care provider needed for mobilization
Measured: 5 days
Mortality
Mortality during ICU and Hospital stay and 180 days after admission at ICU
Measured: at 180 days after study start
Length of stay
Length of stay at ICU , in Hospital (in days)
Measured: Hospital stay (approx. 30 days)
Global function
Global function measured with WHODAS
Measured: at 180 days after study start
Health care provider assessment
Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)
Measured: 5 days
Safety events
Frequency of safety events during mobilization
Measured: 5 days after study start
Functional status
Measurement of ADLs/IADLs for which patients need assistance
Measured: at 180 days after study start
DRG workplace data
expenses of the hospital stay
Measured: Hospital stay (approx. 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start29 Mar 2021
- Primary completion8 Aug 2021
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 20 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
- NCT04750265
- Sponsor's protocol ID
- ROBEM II
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Depersonalized data can be requested from the PI after publication of the study for scientific purpose.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)
- ClinicalTrials.gov ID
- NCT04750265
- Acronym / sponsor ID
- ROBEM II
- Conditions
- Covid19, Critical Illness, Critical Illness Polyneuromyopathy, Early Mobilization, Rehabilitation, Robotics
- Keywords
- COVID19, Early mobilization, robotics, Vemo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Reactive Robotics GmbH
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 8 Aug 2021 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 11 Feb 2021 (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 the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
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 mobilizationEarly mobilization therapy assisted with robotics |
| Standard Care | No intervention | –Mobilization according to standard care by staff |
Who may qualify
- Ages
- 18 to 100 years
- 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 (17 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 mobilizationRobotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission. | Device | Robotic assisted early mobilization |
Primary outcome
Level of mobilization
Time frame: 5 days
Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)
Level of mobilization
Time frame: 5 days
Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)
18 secondary outcomes
Frequency of Mobilization
Time frame: 5 days
Initiation of first Mobilization
Time frame: 5 days
Mobilization duration
Time frame: 5 days
Depth of sedation
Time frame: 5 days
Days of sedation
Time frame: during ICU stay (normally up to 30 days)
Days of mechanical ventilation
Time frame: during ICU stay (normally up to 30 days)
Days of Intubation
Time frame: during ICU stay (normally up to 30 days)
Days of Delirium
Time frame: during ICU stay (normally up to 30 days)
MRC Score
Time frame: One time point before ICU Discharge
Muscle wasting
Time frame: 5 days
Number of Health care provider
Time frame: 5 days
Mortality
Time frame: at 180 days after study start
Length of stay
Time frame: Hospital stay (approx. 30 days)
Global function
Time frame: at 180 days after study start
Health care provider assessment
Time frame: 5 days
Safety events
Time frame: 5 days after study start
Functional status
Time frame: at 180 days after study start
DRG workplace data
Time frame: Hospital stay (approx. 30 days)
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 14 Aug 2023.
- Individual participant dataSharing planned: Yes. Depersonalized 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 in people with Covid19 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 17 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 14 Aug 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?
Level of mobilization (time frame: 5 days). 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 14 Aug 2023.