跳至主要内容
临床试验/NCT02960984
NCT02960984Unknown不适用

Effects of Neurorehabilitation on Upper Limb Performance and on Fatigue in People With Multiple Sclerosis

Fondazione Don Carlo Gnocchi Onlus2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Change from Baseline in Heart Rate at 2 and 4 months

研究概览

简要总结

In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life.

Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training.

The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Multiple Sclerosis
  • no relapses in the last three months
  • Expanded Disability Status Scale (EDSS) ≤ 8;

排除标准

  • subjects with relapses
  • worsening of the pathology in the last three months
  • subjects with cognitive and psychiatric disturbances
  • subjects with cardiovascular disease

结局指标

主要结局

Change from Baseline in Heart Rate at 2 and 4 months

时间窗: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol

Change from Baseline in 9-hole peg test at 2 and 4 months

时间窗: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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