Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease
|Parkinson's Disease||Other: Osteopathic Manipulative Medicine Treatment Other: Light Touch sham|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease|
- Pulmonary Function tests [ Time Frame: 1 day ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||May 2016|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: OMM Treatment
In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.
Other: Osteopathic Manipulative Medicine Treatment
Osteopathic Manipulative Medicine Treatment
Sham Comparator: Light Touch sham
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.
Other: Light Touch sham
Light Touch sham
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636011
|United States, New York|
|NYIT NYCOM Academic Health Care Center|
|Old Westbury, New York, United States, 11568|
|Principal Investigator:||Sheldon Yao, DO||NYIT|