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

NCT03536403 | Completed

• 1 other identifier: 2016/066/HP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Kyphosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Position of the ground point projection of the center of mass

  1 hour

• vertical deceleration 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

  1 hour

Study Arms (1)

healthy volunteers

EXPERIMENTAL

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; Other: 8-meters walk test

Interventions

EOS X-rays RADIATION

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

healthy volunteers

8-meters walk test OTHER

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

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

• Ould-Slimane M, Latrobe C, Michelin P, Chastan N, Dujardin F, Roussignol X, Gauthe R. Noninvasive Optoelectronic Assessment of Induced Sagittal Imbalance Using the Vicon System. World Neurosurg. 2017 Jun;102:425-433. doi: 10.1016/j.wneu.2017.03.099. Epub 2017 Mar 30.

  PMID: 28366752 RESULT

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mourad OULD SLIMANE, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 24, 2018
• Study Start: December 17, 2018
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

FR (1)