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临床试验/NCT05075109
NCT05075109已完成不适用

Effects of Transcutaneous Electrical Nerve Stimulation on Upper Limb Spasticity, Strength and Functional Status in Stroke Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Modified Ashworth Scale (MAS)

研究概览

简要总结

study aims to evaluate the efficacy of high and low frequency TENS on spasticity, strength and functional status in stroke patients. It may provide further knowledge concerning the use of TENS for motor impairments in stroke patients and may clarify ambiguities to some extent.

详细描述

Despite the positive effects of electrical stimulation proved on motor impairments of affected limb, the evidence is still not conclusive. There still remains a question mark regarding the effectiveness and optimal stimulation parameters of TENS. there has been conflict regarding the TENS parameters (frequency, duration, intensity) among different studies. To date TENS parameters used in different studies to reduce spasticity range from frequency of 1.7-100 Hz, duration from 15-60 minutes and sessions from 1-30. The use of different parameters may account for the contradictory results related to effectiveness of TENS.

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
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both male and female aged 40-70 years
  • •Middle cerebral artery (MCA) stroke
  • •6 months after stroke
  • •Mini-mental state examination (MMSE)more than 24
  • •Modified Ashworth scale score between1 and 2

排除标准

  • •Patients with multiple sclerosis, spinal cord injury or with other pre-existing neurological disorders.
  • •Patients with orthopedic condition affecting upper extremity
  • •Patients with contraindication to TENS, like skin damaged etc.

研究组 & 干预措施

High Frequency TENS

Experimental

high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.

干预措施: High Frequency TENS (Device)

Low Frequency TENS

Experimental

low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks with task related training.

干预措施: Low Frequency TENS (Device)

Task Related Training

Active Comparator

postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns

干预措施: Task Related Training (Other)

结局指标

主要结局

Modified Ashworth Scale (MAS)

时间窗: 8 weeks

Modified Ashworth Scale (MAS) is a subjective method used clinically to measure spasticity. It has verified validity to test spasticity. MAS is six point scale (0,1,2,3,4,5) with a 0 indicating no resistance and 5 indicating rigidity. It has good intra and inter-rater reliability with inter-rater reliability of r= 0.92 and intra-rater reliability at r=0.86.

次要结局

  • Manual Muscle Testing (MMT)(8 weeks)
  • Action Research Arm Test (ARAT)(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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