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Clinical Trials/NCT01636011
NCT01636011
Completed
Not Applicable

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

New York Institute of Technology1 site in 1 country50 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
New York Institute of Technology
Enrollment
50
Locations
1
Primary Endpoint
Pulmonary Function tests
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pulmonary Function tests

Time Frame: 1 day

Study Sites (1)

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