Normative Dynamic & Magnetic Spine

NCT03125434 | Terminated

• 1 other identifier: 2016-A01825-46
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe normal spinal musculoskeletal patterns in healthy adolescents and young adults by using static and dynamic measures. Static informations are obtained from full-spine stereoradiography for skeletal measures and from high-resolution spine muscle MRI for muscular data. Dynamics stability is calculated from 3D gait analysis.

Conditions

Healthy Volunteers; Dynamic Stability Margin; Gait; Paraspinal Muscles

Outcome Measures

Primary Outcomes (1)

• Normal dynamic stability margin (DSM) in children and adults

  DSM= xCoM (extrapolated center of mass)- BoS (Base of Support). Unit = meters Normalized on body height (m)

  2 hours

Secondary Outcomes (2)

• number of rotatores muscles

  2 hours

• volume of back muscles

  2 hours

Study Arms (1)

healthy volunteers

EXPERIMENTAL

EOS full-spine, MRI, gait analysis

Other: EOS full-spine, MRI, gait analysis

Interventions

EOS full-spine, MRI, gait analysis OTHER

full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed

healthy volunteers

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent signed by adult or by the holders of parental authority for the children and adolescents
• Child or teenager, male or female, aged from 8 years to 17 years inclusive
• Adult, male or female, aged from 18 years to 40 years inclusive
• Realization of a preliminary medical examination

You may not qualify if:

• Refuse to participate to the study
• Patient under guardianship or curatorship
• Inability to cooperate
• Pregnant woman
• Non affiliation to social security
• Subject with spinal and/or lower limbs affection
• Subject with antecedent of spinal and/or lower limbs surgery
• Subject with contraindication to MRI
• Refusal of the parent or the subject to be informed about a fortuitous discovery during the examinations of the exams

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

APHP Hopital raymond Poincaré

Garches, Île-de-France Region, 92380, France

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Gait Analysis

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 24, 2017
• Study Start: April 27, 2017
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)