Effect of Whole-Body Vibration Versus Neuro Muscular Electrical Stimulation on Patients With Intensive Care Acquired Weakness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Manual muscle test (MMT) and Medical Research Council (MRC)
研究概览
简要总结
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
详细描述
A) 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.
B) Training procedures:
All patients in both groups will receive their plan of treatment in addition to the training program for each group as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients who were aged ≥ 18 and <
- •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/
- •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
排除标准
- •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
- •Implanted pacemaker or defibrillator.
- •Pregnancy.
- •Unhealed fractures or recently attached implants in the body region to be stimulated.
- •Acute venous thrombosis.
研究组 & 干预措施
Group B (NEURO MUSCULAR ELECTRICAL STIMULATION B )
Each patient will receive neuromuscular electrical stimulation for two weeks, twice daily, in addition to their plan of treatment
干预措施: Neuro muscular electrical stimulation (Device)
Group A ( Whole body vibration)
each patient who will practice Whole body vibration for two weeks twice daily in addition to their plan of treatment.
干预措施: whole body VIBRATION Viberation (Device)
结局指标
主要结局
Manual muscle test (MMT) and Medical Research Council (MRC)
时间窗: 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
Medical Research Council (MRC)
时间窗: At baseline and post two weeks
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
Manual muscle test (MMT)
时间窗: At baseline and post two weeks
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
change of Creatine phosphokinase (CPK-MM)
时间窗: change from baseline CPK-MM level at 2 weeks
The Beckman Unicel DxC800 method will be used for measuring serum CPK-MM
muscle strength
时间窗: At baseline and post two weeks
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.
Muscle thickness
时间窗: at baseline and post 2 weeks
Skeletal muscle ultrasonography will be used to assess muscle thickness
次要结局
- change of Creatine phosphokinase (CPK-MM)(Time Frame: change from baseline CPK-MM level at 2 weeks)
- muscle strength(at baseline and post two weeks)
- muscle thickness(at baseline and post two weeks)
研究者
AHMED REFAAT ABD EL AZIZ TAHA MALIK
Principle investigator
Cairo University