Postural Balance of the Adult (POSTURADULT)

This study has been completed.
Sponsor:
Collaborator:
Biospace Med
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00926432
First received: June 18, 2009
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention
Postural Balance
Device: EOS™ Acquisition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Morphologic and positioning parameters of the pelvis (pelvic incidence, pelvic version, sacral slope & pelvic radius) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Kyphosis, lordosis and sinopelvic balance [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • To validate the measure of femoral and tibial torsion using EOS™ images [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • influence of position change on the evaluation of changes in postural balance following surgery [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926432

Locations
France
Unité de Pathologie Rachidienne Tripode CHU Pellegrin, Place Amélie Raba-Léon
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Biospace Med
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
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00926432     History of Changes
Other Study ID Numbers: CHUBX 2008/32
Study First Received: June 18, 2009
Last Updated: May 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 18, 2014