NCT01505556

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

January 4, 2012

Last Update Submit

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

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

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

Respiration DisordersPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

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

Locations