Healthy Volunteers Clinical Trial
— NDMSOfficial title:
Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject
Verified date | January 2021 |
Source | Centre d'Investigation Clinique et Technologique 805 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 48 |
Est. completion date | October 23, 2020 |
Est. primary completion date | October 23, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | APHP Hopital raymond Poincaré | Garches | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Centre d'Investigation Clinique et Technologique 805 |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | number of rotatores muscles | counting every rotatore muscle (from MRI data), no unit | 2 hours | |
Secondary | volume of back muscles | from segmentation of each muscle group, unit = voxel | 2 hours |
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