Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Measuring Nerve Conduction Velocity
研究概览
简要总结
The purpose of the study is to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.
详细描述
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys, and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn't make enough insulin.
Diabetic neuropathies (DNs) are nerve damaging disorders associated with diabetes mellitus. These conditions are thought to result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum) in addition to macrovascular conditions that can culminate in diabetic neuropathy.
The most common characteristics of diabetic neuropathy (DN) are a distal, symmetrical, primarily sensory polyneuropathy affecting the feet and legs in a chronic, slowly progressive manner. The incidence and prevalence of DN associated with duration of diabetes affect up to 50% of diabetic patients. Although DN is known as the most common complications of diabetes. Diabetic neuropathy is estimated that 40% to 50% of people with diabetes will have DN within 10 years of diagnosis.
High tone power therapy (Hi Top) is the percutaneous electrical stimulation of skeletal muscles using alternative frequencies between 4.096 and 32.768 hertz to produce a muscle contraction and the treatment of diabetic neuropathy. The therapy frequency is scanned with a defined frequency. This method is called SimulFAM for Simultaneous Frequency Amplitude Modulation.
High tone power therapy (Hi Top) is a new quantum leap in the field of electro therapy. It is Electrotherapy with sinusoidal alternating currents. The high tone power therapy provides a therapy with medium frequency sine waves. The therapy is free of direct current (D.C.) components. The amplitude and the frequency are modulated simultaneously. The higher the frequency, the more energy can be introduced corresponding to the individual threshold curve of the patient's electrosensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forty type II referred diabetic neuropathy patients from both genders their ages will be ranged from 40-60 years old.
- •All patients with diabetic neuropathy > 10 years having diabetes (will be examined according to the general and specific neurological evaluation sheet for diabetic neuropathy).
- •All patients in the study should be ambulant independently.
- •All patients should be medically stable.
- •The body mass index (BMI) ranged from 20:30 Kg/m
- •All patients will approve and sign a consent form.
排除标准
- •Patients < 10 years having diabetes.
- •Patients with musculoskeletal deformities and disorders.
- •Patients with psychiatric disorders or seizures.
- •Patients with visual and auditory impairment or tremors influencing balance.
- •Patients with other neuromuscular disorders.
- •Patients with BMI more than 30 kg/m
- •Patients with foot deformities and ulcers.
- •Patients with cognitive impairment using mini-mental state examination (MMSE).
- •Patients with lower limb operations.
结局指标
主要结局
Measuring Nerve Conduction Velocity
时间窗: Up to 30 days
Neuro pack M1 EP/EMG measuring system MEB-9200/9300
次要结局
未报告次要终点
研究者
Ahmed Magdy Alshimy
Assistant Lecturer in Neurological Physical Therapy
October 6 University