Muscle Weakness | PatientNCT07336810
Whole-Body Vibration Versus Neuro Muscular Electrical Stimulation on Patients With ICU Acquired Weakness
A study testing whole body VIBRATION Viberation and Neuro muscular electrical stimulation in people with Muscle Weakness | Patient and Intensive Care (ICU) Myopathy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Weakness | Patient, Intensive Care (ICU) Myopathy, Intensive Care (ICU)
- What is being tested?
- whole body VIBRATION Viberation and Neuro muscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2026to 30 Apr 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
critical care department (DR. Sherief Mokhtar unit) in kasr Al-Ainy medical school, Cairo, Egypt.
Cairo, Cairo Governorate, 12345
About this study
Official title: Effect of Whole-Body Vibration Versus Neuro Muscular Electrical Stimulation on Patients With Intensive Care Acquired Weakness
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
Read the detailed description
- Procedure for evaluation:
The practical section of the study will be undertaken in 2 weeks (two sessions per day). Measurements will be taken before the start of the training program then after the end of the 2-week training program in the following manner:
- Manual muscle test (MMT) and medical research council score (MRC): will be used to assess muscle strength.
- Laboratory investigations for CPK: Blood serum samples will be collected. For each sample, 5 mL of blood will be drawn for laboratory analyses to detect damage in skeletal muscle.
- Strength Testing with Dynamometry: A Handheld Dynamometer will be used to assess the skeletal muscle strength objectively.
- Skeletal muscle ultrasonography: will be used to assess the size and thickness of muscles.
- Training procedures:
All patients in both groups will receive their plan of treatment in addition to the training program for each group as follows:
Group (A) patients in this group will participate in Whole Body Vibration (WBV) training for 2 weeks, two sessions per day (total 14 sessions) in addition to their plan of treatment.
Group (B) patients in this group will participate in neuromuscular electrical stimulation (NMES) training for 2 weeks, two sessions per day ( total 14 sessions), in addition to their plan of treatment.
- The statistical analysis will be conducted by using the SPSS statistical package program version 25 for Windows (SPSS, Inc., Chicago, IL). Quantitative descriptive statistics data, including the mean and standard deviation, will be used to describe the data. Multivariate analysis of variance (MANOVA) will be used to compare the tested major dependent variables of interest. A mixed-design 2 x 2 MANOVA test will be used to detect within-group changes and between-group differences. The Bonferroni correction test will be used for pairwise comparison within and between groups of the tested dependent variables, whose P-value will be significant from the MANOVA test. The significance level for all statistical analyses will be set at p<0.05.
- Being tested
- whole body VIBRATION Viberation, Neuro muscular electrical stimulation
- Keywords
- Intensive Care Unit Acquired Weakness, NEURO MUSCULAR ELECTRICAL STIMULATION
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body VIBRATION ViberationDevice
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
Neuro muscular electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Neuro muscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual muscle test (MMT) and Medical Research Council (MRC)
Manual muscle testing will be assessed bilaterally, including tibialis anterior, triceps surae, 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.
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
Measured: At baseline and post two weeks
Secondary outcomes (3)
change of Creatine phosphokinase (CPK-MM)
Description: The Beckman Unicel DxC800 method will be used for measuring serum CPK-MM
Measured: Time Frame: change from baseline CPK-MM level at 2 weeks
muscle strength
A handheld dynamometer 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.
Measured: at baseline and post two weeks
muscle thickness
skeletal muscle ultrasonography will be used to assess muscle thickness
Measured: at baseline and post two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start10 Jan 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Weakness | PatientStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED REFAAT ABD EL AZIZ TAHA MALIK, Cairo University
- Investigators
- Heba A. Abd El Ghafar,, A. Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336810
- Sponsor's protocol ID
- P.T.REC/012/005115
- Other IDs
- P.T.REC/012/005115
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-Body Vibration Versus Neuro Muscular Electrical Stimulation on Patients With Intensive Care Acquired Weakness
- ClinicalTrials.gov ID
- NCT07336810
- Acronym / sponsor ID
- P.T.REC/012/005115
- Keywords
- Intensive Care Unit Acquired Weakness, NEURO MUSCULAR ELECTRICAL STIMULATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 13 Jan 2026 (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.
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
Detailed description
- Procedure for evaluation:
The practical section of the study will be undertaken in 2 weeks (two sessions per day). Measurements will be taken before the start of the training program then after the end of the 2-week training program in the following manner:
- Manual muscle test (MMT) and medical research council score (MRC): will be used to assess muscle strength.
- Laboratory investigations for CPK: Blood serum samples will be collected. For each sample, 5 mL of blood will be drawn for laboratory analyses to detect damage in skeletal muscle.
- Strength Testing with Dynamometry: A Handheld Dynamometer will be used to assess the skeletal muscle strength objectively.
- Skeletal muscle ultrasonography: will be used to assess the size and thickness of muscles.
- Training procedures:
All patients in both groups will receive their plan of treatment in addition to the training program for each group as follows:
Group (A) patients in this group will participate in Whole Body Vibration (WBV) training for 2 weeks, two sessions per day (total 14 sessions) in addition to their plan of treatment.
Group (B) patients in this group will participate in neuromuscular electrical stimulation (NMES) training for 2 weeks, two sessions per day ( total 14 sessions), in addition to their plan of treatment.
- The statistical analysis will be conducted by using the SPSS statistical package program version 25 for Windows (SPSS, Inc., Chicago, IL). Quantitative descriptive statistics data, including the mean and standard deviation, will be used to describe the data. Multivariate analysis of variance (MANOVA) will be used to compare the tested major dependent variables of interest. A mixed-design 2 x 2 MANOVA test will be used to detect within-group changes and between-group differences. The Bonferroni correction test will be used for pairwise comparison within and between groups of the tested dependent variables, whose P-value will be significant from the MANOVA test. The significance level for all statistical analyses will be set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ( Whole body vibration) | Active comparator | Device: whole body VIBRATION Viberationeach patient who will practice Whole body vibration for two weeks twice daily in addition to their plan of treatment. |
| Group B (NEURO MUSCULAR ELECTRICAL STIMULATION B ) | Active comparator | Device: Neuro muscular electrical stimulationEach patient will receive neuromuscular electrical stimulation for two weeks, twice daily, in addition to their plan of treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| whole body VIBRATION ViberationWhole 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 | Device | Group A ( Whole body vibration) |
| Neuro muscular electrical stimulationNeuromuscular 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. | Device | Group B (NEURO MUSCULAR ELECTRICAL STIMULATION B ) |
Primary outcome
Manual muscle test (MMT) and Medical Research Council (MRC)
Time frame: At baseline and post two weeks
Manual muscle testing will be assessed bilaterally, including tibialis anterior, triceps surae, 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. 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
3 secondary outcomes
change of Creatine phosphokinase (CPK-MM)
Time frame: Time Frame: change from baseline CPK-MM level at 2 weeks
muscle strength
Time frame: at baseline and post two weeks
muscle thickness
Time frame: at baseline and post two weeks
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 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Heba A. Abd El Ghafar,, A. Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body VIBRATION Viberation and Neuro muscular electrical stimulation in people with Muscle Weakness | Patient and Intensive Care (ICU) Myopathy, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 8 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 24 Jul 2026. 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 Egypt. 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?
Manual muscle test (MMT) and Medical Research Council (MRC) (time frame: At baseline and post two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.