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临床试验/NCT04192786
NCT04192786Unknown不适用

The Effect of Local Vibration Applied to Spastic Gastrocnemius on Muscle Architecture and Functional Properties in Multiple Sclerosis Patients

Hacettepe University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography

研究概览

简要总结

Gastrocnemius spasticity is one of the main complaints in Multiple Sclerosis patients.Local muscle vibration is a method used for spasticity inhibition. However, when the studies in the literature are examined; It is noted that local vibration applications for spasticity are usually single sessions and evaluate the acute effect, do not produce functional outputs, there is no consensus on frequency and amplitude and the changes in muscle architecture are not examined. In this study, we aimed to investigate the effect of local vibration applied on spastic gastrocnemius on muscle architectural and functional properties in Multiple Sclerosis patients in addition to the standard physiotherapy program. The study was planned to include 3 groups, 2 treatment and 1 control group. The control group will receive standard physiotherapy, one of the treatment groups will receive 50 Hz local vibration in addition to standard physiotherapy, and other treatment group will receive 100 Hz local vibration in addition to standard physiotherapy. Disease severity, gastrocnemius spasticity, architectural and viscoelastic properties of muscle, ankle proprioception, balance and gait skills will be evaluated before and after 8 weeks treatment program. As a result; effectiveness of local vibration in addition to standard physiotherapy program and whether there is a difference between applications at different frequencies will be examined.

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 (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

入选标准

  • > 18 years
  • EDSS<5,5
  • Gastrocnemius spasticity<2

排除标准

  • having any injury or surgery of the lower extremity
  • having systemic and metabolic disease
  • having behavioral and cognitive problems that prevent consistence to guidelines given

结局指标

主要结局

Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography

时间窗: 3 minutes

Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Muscle Thickness and Fascicle Length would be expressed as centimeters.

Evaluation of Pennation Angle with Ultrasonography

时间窗: 2 minutes

Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Pennation Angle would be angularly indicated.

次要结局

  • Assessment of single leg balance(3 minutes)
  • Assessment of balance(10 minutes)
  • Assessment of spasticity(5 minutes)
  • Assessment of viscoelastic properties of muscle(5 minutes)
  • Assessment of ankle proprioception(5 minutes)
  • Assessment of gait characterictics(5 minutes)

研究者

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

Fatma Ayvat

Research Assistant

Hacettepe University

研究点 (2)

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