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临床试验/NCT04190238
NCT04190238Unknown不适用

Efficiency of the Super Inductive System in Spasticity Treatment

Universitatea de Medicina si Farmacie Iuliu Hatieganu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
change in Barthel index

研究概览

简要总结

The aim of the study is to see whether a physical therapy program can relieve pain, decrease spasticity and increase muscle contraction force by using the super inductive system (high frequency electromagnetic field). It is a longitudinal, prospective study, of 60 patients with spasticity after stroke. No new treatment method is tested, as the Super inductive system is approved for physical therapy by the Ministry of Health.

详细描述

The 60 patients will be submitted to 2 treatment groups: 30 patients will receive 10 sessions of the superinductive system on the antagonist muscles, and 30 patients will receive 10 sessions the superinductive system on the agonist and antagonist muscles. All patients will also receive the standard kinetotherapy program for spasticity. The patients will be evaluated at the beginning of the treatment, at 10 days and at 30 days by using the functional MAS index and Barthel index.

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 (Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • spasticity after stroke

排除标准

  • spasticity of other causes

结局指标

主要结局

change in Barthel index

时间窗: day 0, day 10, day 30

measurement of activities of daily living

change in MAS functional index

时间窗: day 0, day 10, day 30

upper extremity functional index

次要结局

未报告次要终点

研究者

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

Ciubean Alina Deniza

Principal investigator

Universitatea de Medicina si Farmacie Iuliu Hatieganu

研究点 (1)

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