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临床试验/NCT01636011
NCT01636011已完成不适用

Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease

New York Institute of Technology2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Pulmonary Function tests

研究概览

简要总结

The purpose of this study is to investigate the effect of selected Osteopathic Manipulative Medicine (OMM) techniques on the respiratory system of people with Parkinson's Disease (PD) in comparison to light touch. Effectiveness will be measured through pulmonary function tests, chest wall expansion, and voice analysis. Selected subjects will be randomly assigned to one of the two groups: OMM treatment group or light touch group. Although OMM treatment has been used on PD patients, a randomized controlled study has not been done to establish its effect on PD respiratory function. The authors believe that this study will show OMM's effectiveness.

详细描述

Osteopathic Manipulative Medicine (OMM) on the thoracic cage and diaphragm is commonly used in clinical practice to address myofascial imbalances, including muscle spasms to improve thoracic cage excursion. Prior research has demonstrated that manual approaches applied to the thoracic cage have positive results with lung function and reducing inflammation.

Parkinson's disease (PD) is a common disabling and progressive neuro-degenerative disorder. Morbidity and mortality are frequently associated with pulmonary dysfunction in patients with PD. Pulmonary function tests (PFT) have been utilized to document respiratory impairment in PD patients. Researchers estimate that 89% of people with PD have speech and voice disorders including disorders of laryngeal, respiratory and articulatory function.

These authors hypothesize that performing OMM on the thoracic cage of PD subjects will show improvement in PFT, chest expansion, and speech production. Subjects with PD meeting the criteria for the study will be randomly assigned to either an OMM treatment or light touch control group. Each subject will be involved in one treatment visit. During this visit, the following will be measured before and after OMM or light touch procedures: maximal and minimal chest circumference; sound pressure, duration, and perceptual measures during sustained vowel phonation and Rainbow Reading; Forced Vital Capacity (FVC), Forced Expiratory Volume/1 second (FEV1), Peak Expiratory Flow (PEF), Forced Expiratory Flow 25%-75% (FEF25-75%), and Maximal Voluntary Ventilation (MVV). Data analysis will be performed with SPSS using Analysis of Covariance to measure significance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, 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

  • Medically diagnosed with Parkinson's Disease
  • on a stable medication dose
  • over the age of 18

排除标准

  • no clinical diagnosis of Parkinson's Disease
  • - medication that might cause pulmonary dysfunction
  • inability to perform PFT because of anatomical abnormalities
  • clinical signs of dementia
  • pacemaker that interferes with pectoral traction
  • metastatic cancer

研究组 & 干预措施

OMM Treatment

Experimental

In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.

干预措施: Osteopathic Manipulative Medicine Treatment (Other)

Light Touch sham

Sham Comparator

In this group the physician uses the dorsum of his hand to the same areas and for the same time that the OMM treatment arm receives.

干预措施: Light Touch sham (Other)

结局指标

主要结局

Pulmonary Function tests

时间窗: 1 day

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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