MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients

Change in total muscle strength assessed by MRC sum score from ICU admission to ICU discharge.

Upper and lower limb muscle strength will be assessed using the Medical Research Council (MRC) sum score. The MRC sum score scale grades voluntary muscle contraction for each muscle group from 0 (no contraction) to 5 (normal strength). Twelve muscle groups will be tested for a total possible best score of 60. A 1-point change in MRC sum score is considered clinically significant.

Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.

Change in hand-grip muscle strength measured by handheld dynamometry from ICU admission to hospital discharge.

Handgrip muscle strength will be assessed using a handheld dynamometer (HHD) as an indicator of global muscle function. Participants will be considered to have ICU-Acquired Weakness (ICUAW) if the average handgrip strength is below the threshold of 11Kg for men or 7 Kg for woman. Higher scores in Kg indicate greater global muscle function.

Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14, and on hospital discharge day.

Change in mobility status assessed by ICU Mobility Scale (IMS) from ICU admission to ICU discharge.

Functional mobility will be assessed using the ICU Mobility Scale (IMS), which ranges from 0 (lying in bed, no active movement) to 10 (walking independently without a gait aid). Higher scores indicate greater mobility.

Time frame: Day 1 (day of enrollment) and daily in the ICU up to Day 14 or upon ICU discharge whichever comes first.

Change in functional exercise capacity assessed by Six-Minute Walk Test (6MWT) between ICU discharge to hospital discharge.

Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) which measures the distance a participant can walk on a flat surface in six minutes. A greater distance walked indicates better functional status.

Time frame: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.

Change in functional exercise capacity assessed by 30-Second Sit-to-Stand Test (30 s STS) between ICU discharge to hospital discharge.

Functional exercise capacity will be assessed using the 30-Second Sit-to-Stand Test (30 s STS) which measures how many times a person can stand up from and sit down (one repetition) in an armless chair in 30 seconds. A higher number of repetitions indicates greater functional capacity.

Time frame: Measured on the day of ICU discharge, average day 7, and on the day of hospital discharge, average day 14.

Change in Rectus Femoris muscle structure assessed by musculoskeletal ultrasound from ICU admission to hospital discharge.

The Rectus Femoris muscle structure will be evaluated using musculoskeletal ultrasound. Measurements will include cross-sectional area, muscle circumference, pennation angle, and echo-intensity. Higher cross-sectional area, muscle circumference, and pennation angle indicate better muscle structure, while increased echo-intensity suggests worse muscle structure.

Time frame: From ICU admission to day 14.

Change in frailty status assessed by Clinical Frailty Scale (CFS) from ICU admission to 3-month post hospital discharge.

Frailty will be assessed using the Clinical Frailty Scale (CFS), which ranges from 1 (very fit) to 7 (severely frail). Higher scores are worse.

Time frame: Enrollment to 3-month follow-up.

Change in functional independence assessed by Barthel Index from ICU discharge to hospital discharge.

Functional independence will be assessed using the Barthel Index, which measures patient's ability in 10 activities of daily living (feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, chair transfers, mobility on level surfaces, and stairs). A higher score closer to 100 indicate greater functional independence.

Time frame: Enrollment to 3-month follow-up.

Change in fatigue severity assessed by Visual Analog Scale for Fatigue (VAS-F) from ICU admission to hospital discharge.

Fatigue will be assessed using the Visual Analog Scale for Fatigue (VAS-F), where participants rate their fatigue on a scale from 0 (no fatigue) to 10 (worst possible fatigue). Higher scores indicate greater fatigue.

Time frame: From ICU admission up to Day 14 or upon ICU discharge whichever comes first.

Change in health-related quality of life assessed by the RAND 36-Item Health Survey (SF-36) from the time of hospital discharge to 3-month follow-up after hospital discharge.

Health-related quality of life will be assessed using the RAND 36-Item Health Survey (SF-36), which evaluates eight domains including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health. Scores range from 0 to 100, with higher scores indicating better health status.

Time frame: Hospital discharge to 3-month follow-up after hospital discharge.

Change in employment status and work ability after hospital discharge.

Employment status will be assessed during follow-up after hospital discharge using a structured questionnaire. Participants will report their current employment status and whether their ICU stay affected their ability to work. Return to work is considered best outcome.

Time frame: From ICU discharge to 3-month follow up after hospital discharge.

Duration of mechanical ventilation.

The number of days from the initiation of mechanical ventilation to the discontinuation of mechanical ventilation. A lower number of days is better.

Time frame: From ICU admission to ICU discharge, an average of 7 days.

Number of ventilator-free days within 28 days after ICU admission.

Ventilator-free days will be calculated as 28 minus total number of days on invasive mechanical ventilation during which the participant is alive and not receiving invasive mechanical ventilation. Participants who die within 28 days will be assigned zero ventilator-free days.

Time frame: From extubation to day 28.

Number of days in ICU, hospital ward, and total hospital stay from admission to discharge.

Length of stay will be recorded in three categories: (1) ICU stay, defined as the total number of consecutive days from ICU admission to ICU discharge; (2) ward stay, defined as the number of days spent in a hospital ward after ICU discharge; and (3) total hospital stay, defined as the number of days from hospital admission to hospital discharge. The shorter the length of stay, the better.

Time frame: From hospital admission to hospital discharge, an average of 14 days.

Discharge location after hospital stay.

Discharge location will be recorded at the time of hospital discharge using predefined categories: home, home with home health services, inpatient rehabilitation facility, skilled nursing facility, long-term acute care hospital, hospice, or death. Discharge home is considered the best outcome.

Time frame: At the last day of hospitalization, average day 14.

Number of participants tolerating electrical muscle stimulation sessions during ICU stay.

Treatment session tolerance will be assessed using standardized scales. Tolerance is defined as: * CPOT less than 7 * NRS less than 8 at the thigh level * RASS less than +3 Scale ranges: * CPOT (0 = relaxed, 8 = severe pain/agitation) * NRS for pain (0 = no pain, 10 = worst pain), * RASS (-5 = unarousable, +4 = combative)

Time frame: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.

Number of participants with electrical interference on ECG monitoring during the stimulation sessions in the ICU.

Electrical interference with cardiac monitoring will be assessed during each electrical muscle stimulation (EMS) session using ECG tracings from standard ICU cardiac monitoring devices. Interference is defined as continuous 60-cycle (60 Hz) artifact for more than 60 seconds that impairs accurate interpretation of cardiac rhythm. ECG data will be captured only during EMS intervention sessions. Success is defined as 20% or less of ECG samples showing electrical interference as defined above.

Time frame: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.

Number of participants achieving significant muscle contraction during electrical muscle stimulation sessions as assessed by Muscle Contraction Scale during the ICU stay.

"Muscle contraction during electrical muscle stimulation (EMS) sessions will be assessed using the Muscle Contraction Scale, which classifies contraction from Type 1 (no palpable or visible contraction) to Type 5 (palpable and visible contraction with full muscle bulk). Participants achieved a response if they scored muscle contraction grade 3 or higher.

Time frame: From day 1 in the ICU up to 7 days or ICU discharge whichever comes first.