Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System (NCT03536403) | Clinical Trial Compass
CompletedNot Applicable
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
France36 participantsStarted 2018-12-17
Plain-language 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
Who can participate
Age range
18 Years – 40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variations in spino-pelvic sagittal balance measured by EOS X-ray