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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01505556
Other study ID # 2012_SBrumagne_DiaphParesis
Secondary ID 1.5.104.03, G.06
Status Withdrawn
Phase
First received
Last updated
Start date January 2014
Est. completion date January 2015

Study information

Verified date February 2019
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Locations

Country Name City State
Belgium Katholieke Universiteit Leuven Leuven Vlaams-Brabant

Sponsors (2)

Lead Sponsor Collaborator
KU Leuven Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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