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NCT Number: NCT01636011

Effect of Osteopathic Manipulative Medicine (OMM) 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Communication Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Speech Synucleinopathies Verbal Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYIT NYCOM Academic Health Care Center

Old Westbury, New York, 11568, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Medicine Treatment

Other

Osteopathic Manipulative Medicine Treatment

Light Touch sham

Other

Light Touch sham

Primary outcomes

  1. Pulmonary Function tests

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Jul 10, 2012
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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