Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- sway index of sensory integration test
研究概览
简要总结
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.
详细描述
PURPOSE:
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.
BACKGROUND:
Diabetic polyneuropathy is the most prevalent chronic complication affecting 30% - 50% of diabetic patients. Diabetic polyneuropathy usually affect the peripheral, autonomic, and central nervous systems with several clinical symptoms .About 80% of the cases of DN manifest as distal symmetrical sensorimotor polyneuropathy which is responsible for cases of chronic pain; impaired sleep quality; increase of the falling risk associated with weakness and increase of the risk of extremities amputation. Transcranial direct current stimulation is neurophysiologic intervention that alters cortical excitability to enhance lower extremity somato-sensation and thus improve functional outcomes.
HYPOTHESES:
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
- Single (Participant)
盲法说明
single blind masking
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1 - Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes.
- •2-The age of the patients ranged from 35 to 55 years.
- •3-Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness
- •4-Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis.
排除标准
- •History of diabetic ulcer and amputation .
- •Osteoporosis.
- •Fractures of lower limbs.
- •Gross musculoskeletal problems eg:burn.
- •Significant Scar tissue or calluses on the feet.
- •Peripheral vascular diseases (PVD) or Microcirculation problems.
- •Balance disturbance rather than diabetic peripheral neuropathy as ear problems, labrynthinitis, stroke or cerebellar problems.
- •Visual disturbance.
- •Autonomic neuropathy.
- •Advanced Osteoarthritis of lower limbs.
- •Nerve root compression (Radicuolopathy) affecting lower limbs.
- •Patients with implanted devices for pain control such as deep brain
结局指标
主要结局
sway index of sensory integration test
时间窗: two months
sway index of sensory integration test will be measured by biodex balance system
次要结局
- risk of fall index(two months)
研究者
Sara Salah El-Din Abdel Megeed
principal investigator
MTI University