ClinicalTrials.gg
CompletedNCT03536403VICON-SPINEUpdated Apr 17, 2026

Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System

An interventional study of EOS X-rays and 8-meters walk test in Kyphosis, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Male
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Study summary

Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain, radicular pain, neurologic complications, or spinal deformities. However, radiography does not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait remain largely unexplored. This prospective and controlled study try to assess the Vicon system for detecting sagittal spinopelvic imbalance and to determine the modification induced by ant induced anterior sagittal imbalance on the kinetics walking parameters

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Conditions studied

  • Kyphosis

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In context

Kyphosis

132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.

This study's enrollment of 36 is below the median of 44 across 82 interventional studies indexed under Kyphosis.

Browse Kyphosis studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male subjects
  • Aged between 20 to 40 years
  • Height between 165 to 190 centimeters
  • Asymptomatic subjects from spinal point of view
  • \< 30 kg/m²
  • Affiliated to French Social Security
  • Subjects having read the information note and signed

Exclusion criteria

Exclusion Criteria:

  • Subjects with neurological, vestibular, rheumatological or orthopedic pathology which can influence walking and balance
  • Subjects with known spinal pathology
  • Subjects with visible morphologic spinal deformity
  • Subjects with significant visual impairment (visual acuity \< 6/10) despite an optical correction port
  • Subjects unable to walk without help
  • Person placed under the safeguard of justice, guardianship or curatorship
  • Subjects involved in other biomedical research during this study
  • Subjects presenting an asymptomatic spinal pathology discovered at the inclusion on the spinal EOS images.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    healthy volunteers

    EOS X-rays is done with et without a kyphosis induced corset and 8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset

    Radiation: EOS X-rays · Other: 8-meters walk test

Interventions

  • RadiationEOS X-rays

    EOS X-rays is done with et without a kyphosis induced corset

  • Other8-meters walk test

    8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset

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What researchers measure

Primary outcomes

  1. Variations in spino-pelvic sagittal balance measured by EOS X-ray

    Variations in spino-pelvic sagittal balances measured with et without a kyphosis induced corset measured by the GSC7 on EOS X-rays and by the C7-T10-Sacrum angle on optoelectronic Vicon system.

    Time frame: 1 hour

Secondary outcomes

  1. Position of the ground point projection of the center of mass

    Position of the ground point projection of the center of mass with and without corset

    Time frame: 1 hour

  2. vertical deceleration of the center of mass during the second part of the oscillating phase

    vertical deceleration of the center of mass during the second part of the oscillating phase with and without corset.

    Time frame: 1 hour

  3. Velocity of the center of mass during the second part of the oscillating phase

    Velocity of the center of mass during the second part of the oscillating phase with and without corset.

    Time frame: 1 hour

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Study locations

1 site
  • Rouen University Hospital
    Rouen, France
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References and documents

Publications

  • Ould-Slimane M, Latrobe C, Michelin P, Chastan N, Dujardin F, Roussignol X, Gauthe R. Noninvasive Optoelectronic Assessment of Induced Sagittal Imbalance Using the Vicon System. World Neurosurg. 2017 Jun;102:425-433. doi: 10.1016/j.wneu.2017.03.099. Epub 2017 Mar 30. PubMed 28366752 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Jan 2020, 12 months.

Of 56 non-industry interventional studies with no phase under Kyphosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 12 months is above that.

Counting every sponsor, half of 58 studies reached it within 9 months; a quarter within 4 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2018
First posted
May 24, 2018
StartActual
Dec 17, 2018
Primary completionActual
Jan 16, 2020
CompletionActual
Jan 16, 2020
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03536403
Responsible party
Sponsor
First posted
May 24, 2018
Start date
Dec 17, 2018
Primary completion
Jan 16, 2020
Completion
Jan 16, 2020
Last update
Apr 17, 2026

Study contacts

Mourad OULD SLIMANE, MD
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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