Healthy VolunteersNDMSNCT03125434
Normative Dynamic & Magnetic Spine
A study testing EOS full-spine, MRI, gait analysis in people with Healthy Volunteers and Dynamic Stability Margin, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Dynamic Stability Margin, Gait
- What is being tested?
- EOS full-spine, MRI, gait analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2017to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
APHP Hopital raymond Poincaré
Garches, Île-de-France Region, 92380
About this study
Official title: Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject
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.
Read the 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.
- Conditions
- Healthy Volunteers, Dynamic Stability Margin, Gait, Paraspinal Muscles
- Being tested
- EOS full-spine, MRI, gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS full-spine, MRI, gait analysisOther
full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | EOS full-spine, MRI, gait analysis Receives: Other: EOS full-spine, MRI, gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours
Secondary outcomes (2)
number of rotatores muscles
counting every rotatore muscle (from MRI data), no unit
Measured: 2 hours
volume of back muscles
from segmentation of each muscle group, unit = voxel
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start27 Apr 2017
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Why it stopped: funding problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125434
- Sponsor's protocol ID
- 2016-A01825-46
- Acronym
- NDMS
- Status last verified
- Jan 2021
- First submitted
- 21 Mar 2017
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject
- ClinicalTrials.gov ID
- NCT03125434
- Acronym / sponsor ID
- NDMS / 2016-A01825-46
- Conditions
- Healthy Volunteers, Dynamic Stability Margin, Gait, Paraspinal Muscles
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding problems
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: EOS full-spine, MRI, gait analysisEOS full-spine, MRI, gait analysis |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Refuse to participate to the study
- Patient under guardianship or curatorship
- Inability to cooperate
- Pregnant woman
- Non affiliation to social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOS full-spine, MRI, gait analysisfull-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed | Other | healthy volunteers |
Primary outcome
Normal dynamic stability margin (DSM) in children and adults
Time frame: 2 hours
DSM= xCoM (extrapolated center of mass)- BoS (Base of Support). Unit = meters Normalized on body height (m)
2 secondary outcomes
number of rotatores muscles
Time frame: 2 hours
volume of back muscles
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: funding problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS full-spine, MRI, gait analysis in people with Healthy Volunteers and Dynamic Stability Margin, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal dynamic stability margin (DSM) in children and adults (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.