ICUAWMyokinE100 System for ICU Acquired Weakness Prevention
This study aims to prevent ICU acquired weakness using the MyokinE100 system.
Electrical Muscle Stimulation System
Atrophy+13
+ Infections
+ Inflammation
Prevention Study
Summary
Study start date: January 1, 2026
Actual date on which the first participant was enrolled.This clinical trial focuses on testing the safety and usability of a new medical device, the MyokinE100 System, in the Intensive Care Unit (ICU). The device is designed to send electrical signals to the thigh muscles of ICU patients who are at risk of losing muscle strength. The study's main aim is to explore whether this treatment can help slow down muscle weakening, a common issue among critically ill patients. The trial is important as it could potentially improve patient care and recovery in the ICU by addressing the challenge of muscle weakness. During the study, participants will either receive standard care or standard care along with daily 60-minute sessions of electrical muscle stimulation using the MyokinE100 System. Researchers will compare these two groups to evaluate the safety and practicality of the device. Participants' muscle strength will be checked throughout the study. Additionally, they will complete a survey three months after leaving the ICU to assess their recovery progress. The study will investigate if participants experience any medical problems while receiving electrical muscle stimulation in the ICU.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Dell Seton Medical Center at The University of Texas
Austin, United StatesAscension Seton Medical Center Austin
Austin, United States