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临床试验/NCT03938558
NCT03938558已完成不适用

Art for MS - Effects of a 10 Week Multimodal Dance and Art Intervention Program on Fatigue, Fatigability, and Their Related Factors - A Controlled Pilot-trial

Hasselt University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
motor fatigability

研究概览

简要总结

This study is a controlled pilot study with 17 participants with Multiple Sclerosis (MS). The primary goal of this study is to objectively examine the effects of a multimodal dance intervention on walking-related performance fatigability. The secondary aim is to investigate the effects of a multimodal dance intervention on other MS symptoms related to fatigue and fatigability.

The following research questions will be addressed:

  1. Does a multimodal dance intervention have positive effects on walking-related fatigability?
  2. Does a multimodal dance intervention have positive effects on other MS symptoms related to fatigue and fatigability?

详细描述

This study distinguish two groups contributing to a dance and art production. The experimental group will perform 10 weeks of dance training, while the other group will contribute to the production in various ways (e.g. word art, photography, painting, ...).

Measures will be taken before and after the training or assistance in the production.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age between 18 - 70 years
  • Confirmed diagnosis according to the McDonald criteria
  • Able to walk independently or with bilateral support for 6 minutes
  • Signed the informed consent

排除标准

  • Exacerbation or relapse within last 3 months before onset study
  • Other medical conditions interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis, fibromyalgia, Parkinson and stroke)

结局指标

主要结局

motor fatigability

时间窗: week 20

Performance motor fatigability: Calculating the Distance Walked Index (DWI) during 6MWT. Formula for walking-related performance fatigability: DWI = (\[Distance walked at minute 6 - Distance walked at minute 1\]/Distance walked at minute 1) × 100

Trait motor fatigue

时间窗: week 20

Modified Fatigue Impact Scale (MFIS)

次要结局

  • Perceived motor fatigability(week 20)
  • Coördination test with lower limbs(week 20)
  • Performance cognitive fatigability and cognitive capacity(week 20)
  • Trait fatigue(week 20)
  • MSIS-29 Questionnaire(week 20)
  • SF-36 Questionnaire(week 20)
  • T25FW test(week 20)
  • NHPT (Nine hole peck test)(week 20)
  • DGI (Dynamic gait index)(week 20)
  • EmNSA(week 20)
  • ABC scale(week 20)
  • MSWS-12 Questionnaire(week 20)
  • 5xSTS T25FW(week 20)
  • CMI (Cognitive motor interference)(week 20)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Feys

Principal Investigator

Hasselt University

研究点 (2)

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