Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease
This trial is active, not recruiting.
|Treatments||osteopathic manipulative medicine treatment, light touch sham|
|Sponsor||New York Institute of Technology|
|Start date||February 2013|
|End date||November 2015|
|Trial size||50 participants|
|Trial identifier||NCT01636011, BHS-808|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
|Primary purpose||supportive care|
Pulmonary Function tests
time frame: 1 day
Male or female participants at least 18 years old.
Inclusion Criteria: - Medically diagnosed with Parkinson's Disease - on a stable medication dose - over the age of 18 Exclusion Criteria: - 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
|Official title||Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease|
|Principal investigator||Sheldon Yao, DO|
|Description||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.|
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