Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System (VICON-SPINE)

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

Study Overview

• Status: Completed
• Conditions: Kyphosis
• Intervention / Treatment: Radiation: EOS X-rays; Other: 8-meters walk test

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: healthy volunteers; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Mourad OULD SLIMANE, MD, Rouen university hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2018
• Primary Completion (ACTUAL): January 16, 2020
• Study Completion (ACTUAL): January 16, 2020

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (ACTUAL): May 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Kyphosis
• Other Study ID Numbers: 2016/066/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No