Study Stopped
Problems to recruit individuals with diaphragm paresis.
Proprioceptive Postural Control and Diaphragm Paresis
2 other identifiers
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 8, 2019
February 1, 2019
11 months
January 4, 2012
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Proprioceptive postural control
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.
1 year
Study Arms (2)
Diaphragm paresis
Healthy controls
Eligibility Criteria
patients from the University Hospital Leuven - Respiratory Disvision
You may qualify if:
- Age: 18-70 years old
- Unilateral or bilateral diaphragm paresis following paresis of phrenic nerve
- Willingness to sign the informed consent
- Age: 18-70 years old
- Spirometry: FEV1/FVC ≥ 0.7 and FEV1 \> 80%
- Willingness to sign the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- Universitaire Ziekenhuizen KU Leuvencollaborator
Study Sites (1)
Katholieke Universiteit Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Related Publications (1)
Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
PMID: 20393397BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Brumagne, PhD
KU Leuven
- PRINCIPAL INVESTIGATOR
Thierry Troosters, PhD
KU Leuven
- PRINCIPAL INVESTIGATOR
Wim Janssens, MD, PhD
KU Leuven
- PRINCIPAL INVESTIGATOR
Marc Decramer, MD, PhD
KU Leuven
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Simon Brumagne
Study Record Dates
First Submitted
January 4, 2012
First Posted
January 6, 2012
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
February 8, 2019
Record last verified: 2019-02