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Proprioceptive Postural Control and Diaphragm Paresis

This study is not yet open for participant recruitment.
Verified January 2012 by Katholieke Universiteit Leuven
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01505556
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance.

The aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with diaphragm paresis.


Condition
Proprioceptive Postural Control
Respiratory Disorders
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Proprioceptive postural control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Center of pressure displacement (force plate) in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diaphragm paresis
Healthy controls

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients from the University Hospital Leuven - Respiratory Disvision

Criteria

Inclusion Criteria individuals with diaphragm paresis:

  • Age: 18-70 years old
  • Unilateral or bilateral diaphragm paresis following paresis of phrenic nerve
  • Willingness to sign the informed consent

Inclusion Criteria healthy controls:

  • Age: 18-70 years old
  • Spirometry: FEV1/FVC ≥ 0.7 and FEV1 > 80%
  • Willingness to sign the informed consent

Exclusion Criteria:

  • History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
  • One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder
  • Respiratory disorder other than diaphragm paresis
  • Recent diagnosis of cancer
  • Significant cardiovascular comorbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505556

Contacts
Contact: Lotte Janssens, PhD student 003216329082 lotte.janssens@faber.kuleuven.be
Contact: Simon Brumagne, PhD 003216329121 simon.brumagne@faber.kuleuven.be

Locations
Belgium
Katholieke Universiteit Leuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Lotte Janssens, PhD student     003216329082     lotte.janssens@faber.kuleuven.be    
Contact: Simon Brumagne, PhD     003216329121     simon.brumagne@faber.kuleuven.be    
Sub-Investigator: Lotte Janssens, PhD student            
Principal Investigator: Simon Brumagne, PhD            
Principal Investigator: Thierry Troosters, PhD            
Sponsors and Collaborators
Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Simon Brumagne, PhD Katholieke Universiteit Leuven
Principal Investigator: Thierry Troosters, PhD Katholieke Universiteit Leuven
Principal Investigator: Wim Janssens, MD, PhD Katholieke Universiteit Leuven
Principal Investigator: Marc Decramer, MD, PhD Katholieke Universiteit Leuven
  More Information

Publications:

Responsible Party: Simon Brumagne, Prof. dr. Simon Brumagne, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01505556     History of Changes
Other Study ID Numbers: 2012_SBrumagne_DiaphParesis, 1.5.104.03, G.0674.09
Study First Received: January 4, 2012
Last Updated: January 5, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 23, 2013