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临床试验/NCT06793865
NCT06793865招募中不适用

Effect of Russian Current Stimulation for Anterior Tibial Group on Postural Stability and Risk of Falling in Patients With Stroke

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Static postural stability overall stability index (OST)

研究概览

简要总结

This study aimed to examine the effect of Russian current stimulation on Anterior tibial group on postural stability and risk of falling in patients with stroke.

详细描述

Stroke is the second leading cause of death globally and the main cause of disability, with ischemic strokes accounting for about 87% of cases. In 2010, over 11 million ischemic strokes occurred, predominantly in low and middle-income countries, leading to approximately three million deaths. Hemorrhagic strokes account for 13% of cases.

Egypt, with an estimated population of 85.5 million, has a high stroke prevalence of 963 per 100,000 inhabitants. Postural imbalance is a common limitation, affecting 83% of acute stroke patients, and falls are frequent across all stages of recovery, with rates as high as 73% within six months post-discharge. Even in chronic stroke patients, the fall risk remains elevated compared to age-matched controls. Postural imbalance impacts quality of life, and rehabilitation is vital for regaining independence in daily activities.

Up to 30% of stroke survivors experience significant permanent disabilities, and 20% require rehabilitation. Motor impairments, particularly in the lower limbs, limit daily activities, community participation, and quality of life. Poor lower-limb muscle performance affects balance, gait, and functionality, but interventions like Russian current have shown effectiveness in improving walking performance and motor recovery in chronic stroke survivors.

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)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Forty patient with stroke manifest with weakness of anterior tibial group.
  • •Patients with moderate spasticity,
  • •Patient's ages ranged from 40-55 years.
  • •Patients BMI not exceed 30 kg/m².
  • •Medically and clinically stable patients.

排除标准

  • •Patients suffering from psychological, cognitive, or emotional disturbance.
  • •Patients with severe spasticity (3 or more by the modified Ashworth scale).
  • •Patients with atrial fibrillation.
  • •Patients with infectious processes.
  • •Patients with impaired pain sensitivity.
  • •Patients with epilepsy.
  • •Patients with lower limb joint endoprosthetics.

研究组 & 干预措施

Russian Current Stimulation + selected physical therapy exercise

Experimental

Patients received Russian current stimulation for 20 minutes and physical therapy for 40 minutes, 3 times/week for 6 weeks.

干预措施: Selected physical therapy exercise for both limbs (Other)

Placebo Russian Current Stimulation + selected physical therapy exercise

Placebo Comparator

All patients in this group received Russian current for 20 minutes as placebo in addition to the same selected physical therapy exercise for both limbs for 40 minutes.

干预措施: Placebo Russian Current Stimulation for Anterior Tibial Group (Other)

Russian Current Stimulation + selected physical therapy exercise

Experimental

Patients received Russian current stimulation for 20 minutes and physical therapy for 40 minutes, 3 times/week for 6 weeks.

干预措施: Russian Current Stimulation for Anterior Tibial Group (Other)

Placebo Russian Current Stimulation + selected physical therapy exercise

Placebo Comparator

All patients in this group received Russian current for 20 minutes as placebo in addition to the same selected physical therapy exercise for both limbs for 40 minutes.

干预措施: Selected physical therapy exercise for both limbs (Other)

结局指标

主要结局

Static postural stability overall stability index (OST)

时间窗: 6 weeks

It was assessed for both groups through Biodex balance system. A training test was given to each patient followed by three consecutive tests in static mode. Each one lasted for 20 seconds with 10 seconds rest between each, changes were recorded in relation to the center of the platform, and the mean of three tests showing the postural fluctuations of women was automatically calculated by the device, and displayed on the screen of device.

次要结局

  • Berg balance scale(6 weeks)
  • Risk of falls index(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrahman Refaat Mohamed

Principal Investigator

Cairo University

研究点 (1)

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