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

Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03536403
Acronym
VICON-SPINE
Enrollment
36
Registered
2018-05-24
Start date
2018-12-17
Completion date
2020-01-16
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kyphosis

Brief 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

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

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Variations in spino-pelvic sagittal balance measured by EOS X-ray1 hourVariations 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.

Secondary

MeasureTime frameDescription
Position of the ground point projection of the center of mass1 hourPosition of the ground point projection of the center of mass with and without corset
vertical deceleration of the center of mass during the second part of the oscillating phase1 hourvertical deceleration of the center of mass during the second part of the oscillating phase with and without corset.
Velocity of the center of mass during the second part of the oscillating phase1 hourVelocity of the center of mass during the second part of the oscillating phase with and without corset.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMourad OULD SLIMANE, MD

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026