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

Not Applicable

Completed

• Conditions: Kyphosis

• Registration Number: NCT03536403
• Lead Sponsor: University Hospital, Rouen

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2018-12-17
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-16
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variations in spino-pelvic sagittal balance measured by EOS X-ray	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.

Secondary Outcome Measures

Name	Time	Method
Position of the ground point projection of the center of mass	1 hour	Position 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 phase	1 hour	vertical 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 phase	1 hour	Velocity of the center of mass during the second part of the oscillating phase with and without corset.

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France