Whole-Body Vibration Versus Neuro Muscular Electrical Stimulation on Patients With ICU Acquired Weakness

NCT07336810 | Enrolling By Invitation DMC

• 1 other identifier: P.T.REC/012/005115
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: to investigate the effect of Whole-body vibration versus neuro-muscular electrical stimulation on patients with intensive care-acquired weakness. Methods: Sixty patients with Intensive Care Unit-acquired weakness (ICU AW) from both genders will be recruited and randomly assigned into two groups, Group A and Group B. Group A will include 30 patients who will practice Whole body vibration for two weeks twice daily in addition to their plan of treatment. Group B will include 30 patients who will receive neuromuscular electrical stimulation for two weeks, twice daily, in addition to their plan of treatment. All patients will be evaluated pre- and post-treatment for the MRC score, creatine phosphokinase, and total muscle strength and skeletal muscle thickness

Conditions

Muscle Weakness | Patient; Intensive Care (ICU) Myopathy; Intensive Care (ICU)

Keywords

Intensive Care Unit Acquired Weakness; NEURO MUSCULAR ELECTRICAL STIMULATION

Outcome Measures

Primary Outcomes (5)

• Manual muscle test (MMT)

  manual muscle testing will be assessed bilaterally, including tibialis anterior, triceps surau, Quadriceps, hamstrings, biceps brachii, triceps brachii, and wrist extensors. these muscles will be assessed in 5 grades of muscle testing, where grade zero means no contraction and grade five means active movement through the full range of motion against full applied resistance against gravity

  At baseline and post two weeks

• Medical Research Council (MRC)

  The MRC scale will be used for early detection of muscle strength, as it has a score ranging from 0 to 60, where \< 48 means significant weakness

  At baseline and post two weeks

• change of Creatine phosphokinase (CPK-MM)

  The Beckman Unicel DxC800 method will be used for measuring serum CPK-MM

  change from baseline CPK-MM level at 2 weeks

• muscle strength

  Handheld dynamometry (HHD) will be used to measure the muscle strength of the selected muscles by quantifying the force generated when a person pushes or pulls against a stationary device.

  At baseline and post two weeks

• Muscle thickness

  Skeletal muscle ultrasonography will be used to assess muscle thickness

  at baseline and post 2 weeks

Study Arms (2)

Group A ( Whole body vibration)

ACTIVE COMPARATOR

each patient who will practice Whole body vibration for two weeks twice daily in addition to their plan of treatment.

Device: whole body VIBRATION Viberation

Group B (NEURO MUSCULAR ELECTRICAL STIMULATION B )

ACTIVE COMPARATOR

Each patient will receive neuromuscular electrical stimulation for two weeks, twice daily, in addition to their plan of treatment

Device: Neuro muscular electrical stimulation

Interventions

whole body VIBRATION Viberation DEVICE

Whole body vibration will be applied twice daily for two weeks. The patients will be in the supine position during the entire intervention, and no changes in body position will take place to avoid any influence on hemodynamic parameters and vital signs. Following baseline measurements, patients will be mobilized passively for 6 minutes as a warm-up. whole body vibration treatment will be initiated, consisting of a vibration plate device will placed under the patient's feet, with resistance to the end of the bed. The patient's hips and knees will be flexed at about 20°. An elastic strip will provide pressure on the knees, pushing the patient's feet against the vibration device. Whole body vibration sessions took 15 minutes, with 9 minutes of clear vibration time. The vibration frequency will be 25 HZ and the amplitude of 2 mm

Group A ( Whole body vibration)

Neuro muscular electrical stimulation DEVICE

Neuromuscular electrical stimulation will be applied twice daily for two weeks. 20 min per muscle group bilaterally on eight different muscle groups (triceps surau (calf muscle), Quadriceps, Hamstring, biceps brachii, triceps brachii, wrist extensors and shoulder abductors). We will never stimulate counteracting muscle groups at the same time. Electrical impulses of 350 μs duration will be applied at a frequency of 50 Hz. Electrical current will be increased until muscle contraction can be visible or palpable, which can be tolerable and does not cause pain or discomfort, and then it will be maintained at this level for the remainder of the session.

Group B (NEURO MUSCULAR ELECTRICAL STIMULATION B )

Eligibility Criteria

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

You may qualify if:

• ICU patients who were aged ≥ 18 and \<65.
• Sepsis-related Organ Failure assessments (SOFA) score ≥ 9 within the first 72 h after ICU admission.
• Patients with no central and peripheral nervous system injury.
• Expected to be treated in the ICU for more than 1 week.
• Medical Research Council (MRC) sum score of less than 36/60.
• Dominant-hand handgrip dynamometry scores of less than 11 kg (interquartile range (IQR) 10-40) in males and less than 7 kg (IQR 0-7.3) in females

You may not qualify if:

• Patients with comorbidities interfering with or compromising the training, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or unstable acute coronary syndrome.
• Patients are hemodynamically unstable.
• Patients who had a major neurological deficit (upper motor neuron lesion).
• Age \< 18 years and more than 65.
• Implanted pacemaker or defibrillator.
• Pregnancy.
• Unhealed fractures or recently attached implants in the body region to be stimulated.
• Acute venous thrombosis.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

critical care department (DR. Sherief Mokhtar unit) in kasr Al-Ainy medical school, Cairo, Egypt.

Cairo, Cairo Governorate, 12345, Egypt

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Heba A. Abd El Ghafar,, A. Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 13, 2026
• Study Start: January 10, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)