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Postural Balance of the Adult (POSTURADULT)

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ClinicalTrials.gov Identifier: NCT00926432
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
EOS imaging Inc.
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Description of the geometrical configuration of the skeleton with regard to gravity line by patients suffering from spinal disorders that may induce postural troubles

Condition or disease Intervention/treatment Phase
Postural Balance Device: EOS™ Acquisition Not Applicable

Detailed Description:
In clinical routine, 3D analysis of postural balance is only made using clinical examination. When dealing with specific pathologies, in particular spine disorders, a better understanding of the balance could help better treat and prevent late complications. This prospective study aims at describing the pathologies of the musculoskeletal system using 3D reconstruction of the spine, the pelvis and the inferior limbs with regard to gravity line by patients suffering from postural trouble and defining new parameters to assess postural balance

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3D Evaluation of Postural Balance of the Adult Affected by Postural Trouble, Using EOS™ Images and 3D-reconstructions With Regard to Gravity Line.
Study Start Date : July 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Healthy volunteers
Small group of aged healthy volunteers
Device: EOS™ Acquisition
Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.

Patients
Patients consulting for spine disorders that may or may not have postural troubles
Device: EOS™ Acquisition
Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.




Primary Outcome Measures :
  1. To assess the three-dimensional geometrical configuration of the skeleton with respect to the gravity line on a large population of patient presenting a broad spectrum of pathologies inducing postural imbalance. [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. 3D Position of the middle of acoustic meati, of each vertebral body, of the center of both acetabula and the barycentre of the four condyles with respect to the gravity line. [ Time Frame: 1 day ]
  2. Morphologic and positioning parameters of the pelvis (pelvic incidence, pelvic version, sacral slope & pelvic radius) [ Time Frame: 1 day ]
  3. Kyphosis, lordosis and sinopelvic balance [ Time Frame: 1 day ]
  4. To validate the measure of femoral and tibial torsion using EOS™ images [ Time Frame: 1 day ]
  5. influence of position change on the evaluation of changes in postural balance following surgery [ Time Frame: After surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Affiliated to social insurance
  • Informed of the benefits, the risks and the conduction of the study and have given their free informed consent.

For Patients

  • Medical prescription for an EOS™ exam, or for Frontal AND Lateral full-spine radiographs or for a pangonogram.

For Healthy Volunteers

  • 50 years old

Exclusion Criteria:

For Patients

  • Patients that neither need any EOS™ exam, nor Face & Lateral full-spine radiographs, nor pangonogram.

For Healthy Volunteers

  • Children or young adults (<50)
  • Psychiatric or neurologic deficit.
  • Anterior Surgery of Spine or inferior Member
  • Chronic back pain
  • Recent acute back Pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926432


Locations
France
Unité de Pathologie Rachidienne Tripode CHU Pellegrin, Place Amélie Raba-Léon
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
EOS imaging Inc.
Investigators
Principal Investigator: Jean-Marc VITAL, Professor Hospital University, Bordeaux
Study Director: Wafa SKALLI, PhD, Pr Laboratoire de Biomécanique Arts et Metiers ParisTech-CNRS UMR 8005

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00926432     History of Changes
Other Study ID Numbers: CHUBX 2008/32
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by University Hospital, Bordeaux:
Balance
Spine disorders
equilibrium