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Normative Dynamic & Magnetic Spine

Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125434
Acronym
NDMS
Enrollment
48
Registered
2017-04-24
Start date
2017-04-27
Completion date
2020-10-23
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dynamic Stability Margin, Gait, Healthy Volunteers, Paraspinal Muscles

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.

Detailed description

Spinal diseases and deformities in adults (degenerative or traumatic) and children (scoliosis and kyphosis) are major public health issues. Postural imbalance due to spinal deformity is usually measured on static radiographs, using standard X-rays. However, bipedal walk is characteristic from human being and the trunk is the main stabilizer. Pathogenesis of spinal deformities remains undefined. To understand the different mechanisms involved in the pathological field, normal musculoskeletal performances of the spine, in static and dynamic conditions must be identified. Ultra-low doses stereoradiography using the EOS system allows the acquisition of full-spine images in standing position. Furthermore, 3D reconstruction can also be create from both anteroom-posterior and lateral side view. Stereoradiography is used in clinical routine especially in children spinal deformities. High resolution muscular MRI is the only device that can provide a detailed muscular analysis, with detection of abnormalities at an early stage. No mapping of normal paraspinal muscles has been yet realized, particularly regarding to rotatores muscles. Motion analysis is the reference exam to analyse dynamic stability during gait. Several parameters reflecting stability during gait can be collected in different conditions. Recently, the Dynamic Stability Margin has been developed but no standard values especially in healthy children has been published.

Interventions

OTHEREOS full-spine, MRI, gait analysis

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

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Normal dynamic stability margin (DSM) in children and adults2 hoursDSM= xCoM (extrapolated center of mass)- BoS (Base of Support). Unit = meters Normalized on body height (m)

Secondary

MeasureTime frameDescription
number of rotatores muscles2 hourscounting every rotatore muscle (from MRI data), no unit
volume of back muscles2 hoursfrom segmentation of each muscle group, unit = voxel

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026