Patient ActivationMobiStaRNCT05071248
Evaluation of the Effect of Robot-assisted Early Mobilization - Project MobiStaR
A study testing VEMO (Reactive Robotics GmbH) in people with Patient Activation and Mobilization, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Within the MobiStaR project the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to increase the mobilization rate of critically ill intensive care patients significantly, possibly thereby increasing the rehabilitation outcomes for these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Activation, Mobilization, Robotics
- What is being tested?
- VEMO (Reactive Robotics GmbH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2021to 15 May 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
- planned surgical intervention
- postoperative intensive medical and therapeutic treatment
- expected duration of ventilation > 48 hours
- age ≥ 18 years
- preoperative informed consent by the patients in the study
- weight >45 kg and <135 kg
- body height >1.50 m and <1.95 m
Who cannot join
- patient refusal to participate in the study
- unable to give consent
- chronically bedridden before inclusion
- clinical Frailty Scale ≥ 7
- chronic ventilation (over 24h) before ICU admission
- increased intracranial pressure / risk for increased intracranial pressure / recent cerebral hemorrhage
Show all 9Show fewer
- pregnancy
- pre-existing neuromuscular disease resulting in chronic limitation of strength and efficiency
- sternotomy / sternectomy during surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Robot-assisted Early Mobilization on Critically Ill Patients, on the Mobilisation Behaviour and Experience of Mobilizing Professionals and Organisational Processes in an Intensive Care Unit
Within the MobiStaR project the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to increase the mobilization rate of critically ill intensive care patients significantly, possibly thereby increasing the rehabilitation outcomes for these patients and developing a new standard of care for robot-assisted early mobilization.
The intervention study will assess the organizational feasibility of robot-assisted early mobilization (starting in the first 72 hours after admission to the ICU), the behavior and experience of the mobilizing professionals and the effects on patient outcomes in terms of ventilation time, muscle mass (sonographic examination) and physical activity (measured by established scores such as Functional Status Score for ICU (FSS-ICU) and Medical Research Council (MRC) classification).
Read the detailed description
Early mobilization means the mobilization of critically ill patients in the early course after admission to the intensive care unit. The positive influence of early mobilization of critically ill patients on various aspects of patient outcomes has already been demonstrated. However, the implementation of early mobilization in clinical practice is difficult. Especially the high personnel effort is a barrier.
The Munich-based company Reactive Robotics (RR) is currently developing the world's first adaptive robotic assistance system VEMO©, which has CE approval for the planned indication and is to be used in the medium term for mobilizing intensive care patients.
Within the MobiStaR project, the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to significantly increase the mobilization rate of critically ill intensive care patients, possibly thereby increasing the rehabilitation results for these patients and developing a new standard of care for robot-assisted early mobilization. In this project, the robotic system will be used in anesthesiology intensive care units of the Ludwigs-Maximilians-University hospital.
Within this study, the effects of robot-assisted early mobilization will now be evaluated. This study comprises three study arms, in which (1) the feasibility and practicability of robot-assisted early mobilization, (2) the behavior and experience of the mobilizing professionals, and (3) the effect on patient outcomes will be evaluated.
The study is monocentric, prospective, interventional, does not include invasive procedures or blood sampling and has multiple data collection time points.
- The feasibility of robot-assisted early mobilization surveys concomitantly how many VEM therapies can be implemented in how many patients as well as if and which adverse events occur.
- The behavior and experience of the mobilizing professionals will be evaluated by using episodic interviews and standardized observations. Nurses with advanced training in anesthesia and intensive care, nurses and physiotherapists who have at least three years of professional experience in an intensive care unit as well as medical specialists with completed specialist training or a leading position in the intensive care unit will be included.
- The effects on patient outcomes, primarily ventilation duration, muscle mass (sonographic examination) and physical activity (measured by established scores such as FSS-ICU and MRC classification), will be measured at different time points and compared with a historical patient population. Secondary factors such as delirium incidence, hemodynamic parameters, respiratory parameters but also longitudinal parameters such as ICU and hospital length of stay will be analyzed from routine data/patient records. Informed consenting patients undergoing a planned surgical procedure that is postoperatively associated with intensive care treatment and an anticipated duration of ventilation of more than 48 hours will be included. These patients will receive standardized early mobilization using the robotic system at either ten frequencies or for seven days. No invasive procedures such as blood sampling will be performed as part of the study. Outcomes will be compared with a historical comparison group to evaluate the effect of robot-assisted VEM (very early mobilization). Approximately 30 patients will be included. The outcomes will be compared with those of a historical group (n=30) treated with conventional early mobilization.
The intervention is planned for a duration of five to six months starting in September 2021.
- Conditions
- Patient Activation, Mobilization, Robotics
- Being tested
- VEMO (Reactive Robotics GmbH)
- Keywords
- robotics, intensive care unit, VEM, very early mobilization, feasibility, effects on patients' outcomes, mobilising professionals, Sonography, mixed methods, routine data, observations, interview, nursing sciences, physiotherapy, nurse
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEMO (Reactive Robotics GmbH)Device
The robot used for early mobilization is able to verticalize the patients in their bed without transfer and to generate a movement of the legs that measures and supports the patients' own movement. The device meets the requirements for mobilizing critically ill patients in an intensive care unit, maintaining hygiene standards and providing the best possible support for the patient's own movement.
| Study group | Role | What they receive |
|---|---|---|
| patients with robot-assisted early mobilization | Active comparator | All patients will receive a physical examination at various time points to assess physical functionality and muscle strength, as well as a sonographic examination of leg muscles, diaphragm, and lungs. These examinations should be performed on day -1 (preoperatively), on postoperative days 1,2,3, then once a week if the patient remains in the ICU, on day 28, on the day of discharge from the ICU, and on a follow-up examination approximately 3 months after discharge from the ICU.The follow-up examination should only take place if the patients present themselves at the hospital anyway due to medically indicated follow-up examinations (not study-related). Alternatively, patients can be asked about their condition by telephone. Receives: Device: VEMO (Reactive Robotics GmbH) |
| patients with conventional early mobilization (historic group) | No intervention | All patients fulfill the same criteria like the intervention group and receive conventional early mobilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration
changes in ventilation duration (in hours) in comparison to a historical patient group
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination Area of the M.rec.femoris
muscle mass (sonographic examination, in millimeters): Area of the M. rec. femoris in comparison to a historical patient group (in cm²)
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness M. quad. femoris
muscle mass: Thickness M. quad. Femoris (in cm²) in comparison to a historical patient group
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination- motility diaphragm breathing
muscle mass: motility of the diaphragm during breathing (in cm) in comparison to a historical patient group
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm inspiration
muscle mass: Thickness of diaphragm during inspiration (in cm) in comparison to a historical patient group
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm exhalation
muscle mass: Thickness of diaphragm during exhalation (in cm) in comparison to a historical patient group
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity - FSS-ICU
physical activity measured using the score FSS-ICU (0 -35) in comparison to a historical patient group. A higher value means a better outcome.
Measured: 6 months
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity
physical activity on upper and lower extremity measured using the Medical Research Council (MRC) score in comparison to a historical patient group. (0=absent muscle contraction, 1=visible muscle contraction, 2=movement when gravity is eliminated, 3=active movement against gravity, 4=active movement against resistance, 5=normal strength.)
Measured: 6 months
Behavior and experience of the mobilizing professionals - qualitative interviews
subjectively experienced emotions, motivating and challenging factors - evaluated with a semi-structured interview guideline
Measured: 6 months
Behavior and experience of the mobilizing professionals - qualitative observations
behavior and body posture during the mobilization - evaluated with a standardized observation sheet
Measured: 6 months
Feasibility in organizational processes - eligible patients
Frequency of eligible patients (count per week: included patients in the study/ new eligible patients in the ICUs)
Measured: 6 months
Feasibility in organizational processes - mobilizations
frequency of robot-assisted mobilizations (per patient per day)
Measured: 6 months
Feasibility in organizational processes - adverse events
adverse events (count of patient-related, user-related or technology-related adverse events)
Measured: 6 months
Secondary outcomes (14)
Delir
Delir incidence using the CAM ICU: number of days without Delir. 1 = pathological; 2 = normal; 3 = not performed in comparison to a historical patient group
Measured: 6 months
Consciousness
level of consciousness using the Glasgow Coma Scale (3-15) in comparison to a historical patient group
Measured: 6 months
Sedation level
Sedation level using the Richmond Agitation Sedation Scale (RASS) (-5 - +5) in comparison to a historical patient group
Measured: 6 months
Pain (VAS)
Pain - with the use of the Visual Analog Scale (VAS) (before and after mobilization) (0-10) in comparison to a historical patient group
Measured: 6 months
health related quality of life
Health-related quality of life after 3 months using the the SF-36 (Short form questionnaire) (0-100) in comparison to a historical patient group
Measured: 6 months
Blood pressure
hemodynamics - Blood pressure (in mmHg) in comparison to a historical patient group
Measured: 6 months
catecholamine demand
hemodynamics - catecholamine demand (cumulative over 24 hours) in comparison to a historical patient group
Measured: 6 months
heart rate
hemodynamics - heart rate (1/min) in comparison to a historical patient group
Measured: 6 months
cardiac output
hemodynamics - Cardiac output (in l/min) in comparison to a historical patient group
Measured: 6 months
oxygen consumption
hemodynamics - Oxygen consumption (in l) in comparison to a historical patient group
Measured: 6 months
respiration
respiration- Maximum respiratory rate for 24h in comparison to a historical patient group
Measured: 6 months
ICU Score - SOFA
ICU Scores like Sepsis-related organ failure assessment score (SOFA) (0-24) in comparison to a historical patient group. A higher value means a worse outcome.
Measured: 6 months
ICU Scores - APACHE II
ICU Scores like Acute Physiology and Chronic Health Disease Classification System II (APACHE II) (0-71) in comparison to a historical patient group. A higher value means a worse outcome.
Measured: 6 months
ICU Scores - SAPS II
ICU Scores like Simplified Acute Physiology Score II (SAPS II) (0-163) in comparison to a historical patient group. A higher value means a worse outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start15 Sep 2021
- Primary completion15 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient ActivationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The present study is a monocentric, prospective intervention study designed to evaluate the feasibility and * to evaluate the feasibility and integration in the setting of the intensive care unit. * the behavior and experience of the mobilizing specialists of the robot-assisted VEM is to be evaluated longitudinally (three data collection points). * to compare robot-assisted VEM in critically ill ICU patients with non-robot-assisted early mobilization according to the standard of care of a historical patient population.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Catholic University of Eichstätt-Ingolstadt
- Responsible party
- Principal investigator, Dr. Uli Fischer, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Zoller, PD Dr., Principal investigator, Ludwig-Maximilians - University of MunichInge Eberl, Prof. Dr., Principal investigator, Catholic University of Eichstätt-IngolstadtEduard Kraft, PD Dr., Principal investigator, Ludwig-Maximilians - University of MunichUli Fischer, Dr., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071248
- Sponsor's protocol ID
- 16SV842
- Acronym
- MobiStaR
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huebner L, Warmbein A, Scharf C, Schroeder I, Manz K, Rathgeber I, Gutmann M, Biebl J, Mehler-Klamt A, Huber J, Eberl I, Kraft E, Fischer U, Zoller M. Effects of robotic-assisted early mobilization versus conventional mobilization in intensive care unit patients: prospective interventional cohort study with retrospective control group analysis. Crit Care. 2024 Apr 6;28(1):112. doi: 10.1186/s13054-024-04896-1.
PubMed 38582934Warmbein A, Hubner L, Rathgeber I, Mehler-Klamt AC, Huber J, Schroeder I, Scharf C, Gutmann M, Biebl J, Manz K, Kraft E, Eberl I, Zoller M, Fischer U. Robot-assisted early mobilization for intensive care unit patients: Feasibility and first-time clinical use. Int J Nurs Stud. 2024 Apr;152:104702. doi: 10.1016/j.ijnurstu.2024.104702. Epub 2024 Jan 26.
PubMed 38350342Warmbein A, Schroeder I, Mehler-Klamt A, Rathgeber I, Huber J, Scharf C, Hubner L, Gutmann M, Biebl J, Lorenz A, Kraft E, Zoller M, Eberl I, Fischer U. Robot-assisted early mobilization of intensive care patients: a feasibility study protocol. Pilot Feasibility Stud. 2022 Nov 5;8(1):236. doi: 10.1186/s40814-022-01191-0.
PubMed 36333746
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Robot-assisted Early Mobilization on Critically Ill Patients, on the Mobilisation Behaviour and Experience of Mobilizing Professionals and Organisational Processes in an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05071248
- Acronym / sponsor ID
- MobiStaR / 16SV842
- Conditions
- Patient Activation, Mobilization, Robotics
- Keywords
- robotics, intensive care unit, VEM, very early mobilization, feasibility, effects on patients' outcomes, mobilising professionals, Sonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Catholic University of Eichstätt-Ingolstadt
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 8 Oct 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.
Within the MobiStaR project the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to increase the mobilization rate of critically ill intensive care patients significantly, possibly thereby increasing the rehabilitation outcomes for these patients and developing a new standard of care for robot-assisted early mobilization.
The intervention study will assess the organizational feasibility of robot-assisted early mobilization (starting in the first 72 hours after admission to the ICU), the behavior and experience of the mobilizing professionals and the effects on patient outcomes in terms of ventilation time, muscle mass (sonographic examination) and physical activity (measured by established scores such as Functional Status Score for ICU (FSS-ICU) and Medical Research Council (MRC) classification).
Detailed description
Early mobilization means the mobilization of critically ill patients in the early course after admission to the intensive care unit. The positive influence of early mobilization of critically ill patients on various aspects of patient outcomes has already been demonstrated. However, the implementation of early mobilization in clinical practice is difficult. Especially the high personnel effort is a barrier.
The Munich-based company Reactive Robotics (RR) is currently developing the world's first adaptive robotic assistance system VEMO©, which has CE approval for the planned indication and is to be used in the medium term for mobilizing intensive care patients.
Within the MobiStaR project, the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to significantly increase the mobilization rate of critically ill intensive care patients, possibly thereby increasing the rehabilitation results for these patients and developing a new standard of care for robot-assisted early mobilization. In this project, the robotic system will be used in anesthesiology intensive care units of the Ludwigs-Maximilians-University hospital.
Within this study, the effects of robot-assisted early mobilization will now be evaluated. This study comprises three study arms, in which (1) the feasibility and practicability of robot-assisted early mobilization, (2) the behavior and experience of the mobilizing professionals, and (3) the effect on patient outcomes will be evaluated.
The study is monocentric, prospective, interventional, does not include invasive procedures or blood sampling and has multiple data collection time points.
- The feasibility of robot-assisted early mobilization surveys concomitantly how many VEM therapies can be implemented in how many patients as well as if and which adverse events occur.
- The behavior and experience of the mobilizing professionals will be evaluated by using episodic interviews and standardized observations. Nurses with advanced training in anesthesia and intensive care, nurses and physiotherapists who have at least three years of professional experience in an intensive care unit as well as medical specialists with completed specialist training or a leading position in the intensive care unit will be included.
- The effects on patient outcomes, primarily ventilation duration, muscle mass (sonographic examination) and physical activity (measured by established scores such as FSS-ICU and MRC classification), will be measured at different time points and compared with a historical patient population. Secondary factors such as delirium incidence, hemodynamic parameters, respiratory parameters but also longitudinal parameters such as ICU and hospital length of stay will be analyzed from routine data/patient records. Informed consenting patients undergoing a planned surgical procedure that is postoperatively associated with intensive care treatment and an anticipated duration of ventilation of more than 48 hours will be included. These patients will receive standardized early mobilization using the robotic system at either ten frequencies or for seven days. No invasive procedures such as blood sampling will be performed as part of the study. Outcomes will be compared with a historical comparison group to evaluate the effect of robot-assisted VEM (very early mobilization). Approximately 30 patients will be included. The outcomes will be compared with those of a historical group (n=30) treated with conventional early mobilization.
The intervention is planned for a duration of five to six months starting in September 2021.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a monocentric, prospective intervention study designed to evaluate the feasibility and * to evaluate the feasibility and integration in the setting of the intensive care unit. * the behavior and experience of the mobilizing specialists of the robot-assisted VEM is to be evaluated longitudinally (three data collection points). * to compare robot-assisted VEM in critically ill ICU patients with non-robot-assisted early mobilization according to the standard of care of a historical patient population.
| Arm | Type | Receives |
|---|---|---|
| patients with robot-assisted early mobilization | Active comparator | Device: VEMO (Reactive Robotics GmbH)All patients will receive a physical examination at various time points to assess physical functionality and muscle strength, as well as a sonographic examination of leg muscles, diaphragm, and lungs. These examinations should be performed on day -1 (preoperatively), on postoperative days 1,2,3, then once a week if the patient remains in the ICU, on day 28, on the day of discharge from the ICU, and on a follow-up examination approximately 3 months after discharge from the ICU.The follow-up examination should only take place if the patients present themselves at the hospital anyway due to medically indicated follow-up examinations (not study-related). Alternatively, patients can be asked about their condition by telephone. |
| patients with conventional early mobilization (historic group) | No intervention | –All patients fulfill the same criteria like the intervention group and receive conventional early mobilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- planned surgical intervention
- postoperative intensive medical and therapeutic treatment
- expected duration of ventilation > 48 hours
- age ≥ 18 years
- preoperative informed consent by the patients in the study
Key exclusion criteria (9 listed)
- patient refusal to participate in the study
- unable to give consent
- chronically bedridden before inclusion
- clinical Frailty Scale ≥ 7
- chronic ventilation (over 24h) before ICU admission
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 |
|---|---|---|
| VEMO (Reactive Robotics GmbH)The robot used for early mobilization is able to verticalize the patients in their bed without transfer and to generate a movement of the legs that measures and supports the patients' own movement. The device meets the requirements for mobilizing critically ill patients in an intensive care unit, maintaining hygiene standards and providing the best possible support for the patient's own movement. | Device | patients with robot-assisted early mobilization |
Primary outcome
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration
Time frame: 6 months
changes in ventilation duration (in hours) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination Area of the M.rec.femoris
Time frame: 6 months
muscle mass (sonographic examination, in millimeters): Area of the M. rec. femoris in comparison to a historical patient group (in cm²)
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness M. quad. femoris
Time frame: 6 months
muscle mass: Thickness M. quad. Femoris (in cm²) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination- motility diaphragm breathing
Time frame: 6 months
muscle mass: motility of the diaphragm during breathing (in cm) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm inspiration
Time frame: 6 months
muscle mass: Thickness of diaphragm during inspiration (in cm) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm exhalation
Time frame: 6 months
muscle mass: Thickness of diaphragm during exhalation (in cm) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity - FSS-ICU
Time frame: 6 months
physical activity measured using the score FSS-ICU (0 -35) in comparison to a historical patient group. A higher value means a better outcome.
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity
Time frame: 6 months
physical activity on upper and lower extremity measured using the Medical Research Council (MRC) score in comparison to a historical patient group. (0=absent muscle contraction, 1=visible muscle contraction, 2=movement when gravity is eliminated, 3=active movement against gravity, 4=active movement against resistance, 5=normal strength.)
Behavior and experience of the mobilizing professionals - qualitative interviews
Time frame: 6 months
subjectively experienced emotions, motivating and challenging factors - evaluated with a semi-structured interview guideline
Behavior and experience of the mobilizing professionals - qualitative observations
Time frame: 6 months
behavior and body posture during the mobilization - evaluated with a standardized observation sheet
Feasibility in organizational processes - eligible patients
Time frame: 6 months
Frequency of eligible patients (count per week: included patients in the study/ new eligible patients in the ICUs)
Feasibility in organizational processes - mobilizations
Time frame: 6 months
frequency of robot-assisted mobilizations (per patient per day)
Feasibility in organizational processes - adverse events
Time frame: 6 months
adverse events (count of patient-related, user-related or technology-related adverse events)
14 secondary outcomes
Delir
Time frame: 6 months
Consciousness
Time frame: 6 months
Sedation level
Time frame: 6 months
Pain (VAS)
Time frame: 6 months
health related quality of life
Time frame: 6 months
Blood pressure
Time frame: 6 months
catecholamine demand
Time frame: 6 months
heart rate
Time frame: 6 months
cardiac output
Time frame: 6 months
oxygen consumption
Time frame: 6 months
respiration
Time frame: 6 months
ICU Score - SOFA
Time frame: 6 months
ICU Scores - APACHE II
Time frame: 6 months
ICU Scores - SAPS II
Time frame: 6 months
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 11 Oct 2023.
- Derived from this study: PubMed 38582934Huebner L, Warmbein A, Scharf C, Schroeder I, Manz K, Rathgeber I, Gutmann M, Biebl J, Mehler-Klamt A, Huber J, Eberl I, Kraft E, Fischer U, Zoller M. Effects of robotic-assisted early mobilization versus conventional mobilization in intensive care unit patients: prospective interventional cohort study with retrospective control group analysis. Crit Care. 2024 Apr 6;28(1):112. doi: 10.1186/s13054-024-04896-1.
- Derived from this study: PubMed 38350342Warmbein A, Hubner L, Rathgeber I, Mehler-Klamt AC, Huber J, Schroeder I, Scharf C, Gutmann M, Biebl J, Manz K, Kraft E, Eberl I, Zoller M, Fischer U. Robot-assisted early mobilization for intensive care unit patients: Feasibility and first-time clinical use. Int J Nurs Stud. 2024 Apr;152:104702. doi: 10.1016/j.ijnurstu.2024.104702. Epub 2024 Jan 26.
- Derived from this study: PubMed 36333746Warmbein A, Schroeder I, Mehler-Klamt A, Rathgeber I, Huber J, Scharf C, Hubner L, Gutmann M, Biebl J, Lorenz A, Kraft E, Zoller M, Eberl I, Fischer U. Robot-assisted early mobilization of intensive care patients: a feasibility study protocol. Pilot Feasibility Stud. 2022 Nov 5;8(1):236. doi: 10.1186/s40814-022-01191-0.
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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.
Michael Zoller, PD Dr. principal investigator
Ludwig-Maximilians - University of Munich
Inge Eberl, Prof. Dr. principal investigator
Catholic University of Eichstätt-Ingolstadt
Eduard Kraft, PD Dr. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEMO (Reactive Robotics GmbH) in people with Patient Activation and Mobilization, run by Ludwig-Maximilians - University of Munich 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 7 inclusion and 9 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 11 Oct 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?
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration (time frame: 6 months). The study lists 13 primary outcomes in all. 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 NCT05071248, which also lists 3 linked publications.
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 11 Oct 2023.