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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York Institute of Technology
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT01636011
First received: July 5, 2012
Last updated: September 23, 2014
Last verified: September 2014

July 5, 2012
September 23, 2014
February 2013
May 2015   (final data collection date for primary outcome measure)
Pulmonary Function tests [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01636011 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effect of Osteopathic Manipulative Medicine (OMM) on Pulmonary Function and Speech in Parkinson's Disease
Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Parkinson's Disease
  • Other: Osteopathic Manipulative Medicine Treatment
    Osteopathic Manipulative Medicine Treatment
  • Other: Light Touch sham
    Light Touch sham
  • Experimental: OMM Treatment
    In this group the subjects are given 5 different OMM treatments addressing the thoracic cage.
    Intervention: Other: 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.
    Intervention: Other: Light Touch sham

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
May 2016
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sheldon Yao, DO 516-686-3754 syao@nyit.edu
United States
 
NCT01636011
BHS-808
Not Provided
New York Institute of Technology
New York Institute of Technology
Not Provided
Principal Investigator: Sheldon Yao, DO NYIT
New York Institute of Technology
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP