Evaluation of the Effect of Robot-assisted Early Mobilization - Project MobiStaR

NCT05071248 | Completed

• 1 other identifier: 16SV842
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Patient Activation; Mobilization; Robotics

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

Outcome Measures

Primary Outcomes (13)

• 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

  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)

  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

  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

  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

  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

  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.

  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.)

  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

  6 months

• Behavior and experience of the mobilizing professionals - qualitative observations

  behavior and body posture during the mobilization - evaluated with a standardized observation sheet

  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)

  6 months

• Feasibility in organizational processes - mobilizations

  frequency of robot-assisted mobilizations (per patient per day)

  6 months

• Feasibility in organizational processes - adverse events

  adverse events (count of patient-related, user-related or technology-related adverse events)

  6 months

Secondary Outcomes (14)

• Delir

  6 months

• Consciousness

  6 months

• Sedation level

  6 months

• Pain (VAS)

  6 months

• health related quality of life

  6 months

Study Arms (2)

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.

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.

Interventions

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.

patients with robot-assisted early mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient refusal to participate in the study
• unable to give consent
• clinical Frailty Scale ≥ 7
• chronic ventilation (over 24h) before ICU admission
• increased intracranial pressure / risk for increased intracranial pressure / recent cerebral hemorrhage
• pregnancy
• pre-existing neuromuscular disease resulting in chronic limitation of strength and efficiency
• sternotomy / sternectomy during surgical procedure

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• German Federal Ministry of Education and Research: collaborator
• Catholic University of Eichstätt-Ingolstadt: collaborator

Study Sites (1)

LudwigMaximilians

Munich, Bavaria, 81337, Germany

Location

Related Publications (3)

• 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.

  PMID: 38582934 DERIVED

• Warmbein 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.

  PMID: 38350342 DERIVED

• Warmbein 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.

  PMID: 36333746 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michael Zoller, PD Dr.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

• Inge Eberl, Prof. Dr.

  Catholic University of Eichstätt-Ingolstadt

  PRINCIPAL INVESTIGATOR

• Eduard Kraft, PD Dr.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

• Uli Fischer, Dr.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of executive department nursing science

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: October 8, 2021
• Study Start: September 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: May 15, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

DE (1)