跳至主要内容
临床试验/NCT02821663
NCT02821663Unknown不适用

Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
MOS 36-Item Short Form Health Survey

研究概览

简要总结

Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.

详细描述

This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism

排除标准

  • affection of the vocal apparatus
  • dyspnea at rest
  • oxygen prescription

结局指标

主要结局

MOS 36-Item Short Form Health Survey

时间窗: up to 4 weeks

The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.

次要结局

  • Secretory immunoglobulin A; mg/l(up to 4 weeks)
  • 6-minutes walk test(up to 4 weeks)
  • Mouth open; in millimeter(up to 4 weeks)
  • Saliva cortisol; ng/ml(up to 4 weeks)

研究者

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

Michael Mickel

MD

Medical University of Vienna

研究点 (2)

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