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
  Purpose

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.


Condition Intervention
Parkinson's Disease
Other: Osteopathic Manipulative Medicine Treatment
Other: Light Touch sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Osteopathic Manipulative Medicine on Pulmonary Function and Speech in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by New York Institute of Technology:

Primary Outcome Measures:
  • Pulmonary Function tests [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: February 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636011

Contacts
Contact: Sheldon Yao, DO 516-686-3754 syao@nyit.edu

Locations
United States, New York
NYIT NYCOM Academic Health Care Center Recruiting
Old Westbury, New York, United States, 11568
Principal Investigator: Sheldon Yao, DO         
Sponsors and Collaborators
New York Institute of Technology
Investigators
Principal Investigator: Sheldon Yao, DO NYIT
  More Information

Publications:

Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT01636011     History of Changes
Other Study ID Numbers: BHS-808
Study First Received: July 5, 2012
Last Updated: September 23, 2014
Health Authority: United States: Department of Health and Human Services
United States: Institutional Review Board

Keywords provided by New York Institute of Technology:
Parkinson's Disease
Osteopathic Manipulative Medicine
Speech
Pulmonary Function

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 01, 2014