KyphosisVICON-SPINENCT03536403
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
A study testing EOS X-rays and 8-meters walk test in people with Kyphosis, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Kyphosis
- What is being tested?
- EOS X-rays and 8-meters walk test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2018to 16 Jan 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects
- Aged between 20 to 40 years
- Height between 165 to 190 centimeters
- Asymptomatic subjects from spinal point of view
- BMI < 30 kg/m²
- Affiliated to French Social Security
- Subjects having read the information note and signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis
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
- Conditions
- Kyphosis
- Being tested
- EOS X-rays, 8-meters walk test
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS X-raysRadiation
EOS X-rays is done with et without a kyphosis induced corset
8-meters walk testOther
8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | 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 Receives: Radiation: EOS X-rays; Other: 8-meters walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (3)
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
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start17 Dec 2018
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KyphosisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mourad OULD SLIMANE, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536403
- Sponsor's protocol ID
- 2016/066/HP
- Acronym
- VICON-SPINE
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2018
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis
- ClinicalTrials.gov ID
- NCT03536403
- Acronym / sponsor ID
- VICON-SPINE / 2016/066/HP
- Conditions
- Kyphosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 24 May 2018 (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.
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
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 | Radiation: EOS X-rays, Other: 8-meters walk testEOS 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male subjects
- Aged between 20 to 40 years
- Height between 165 to 190 centimeters
- Asymptomatic subjects from spinal point of view
- BMI < 30 kg/m²
Key exclusion criteria (8 listed)
- 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
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 X-raysEOS X-rays is done with et without a kyphosis induced corset | Radiation | healthy volunteers |
| 8-meters walk test8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset | Other | healthy volunteers |
Primary outcome
Variations in spino-pelvic sagittal balance measured by EOS X-ray
Time frame: 1 hour
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.
3 secondary outcomes
Position of the ground point projection of the center of mass
Time frame: 1 hour
vertical deceleration of the center of mass during the second part of the oscillating phase
Time frame: 1 hour
Velocity of the center of mass during the second part of the oscillating phase
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 28366752Ould-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.
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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.
Mourad OULD SLIMANE, MD principal investigator
University Hospital, Rouen
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 X-rays and 8-meters walk test in people with Kyphosis, run by University Hospital, Rouen 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 17 Apr 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variations in spino-pelvic sagittal balance measured by EOS X-ray (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536403, which also lists 1 linked publication.
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 17 Apr 2026.