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

Kyphosis Clinical Trial

— VICON-SPINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536403
• Other study ID #: 2016/066/HP
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: January 16, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kyphosis

Intervention

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

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour
Secondary	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	1 hour
Secondary	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.	1 hour
Secondary	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.	1 hour