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Completed

NCT Number: NCT03536403

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

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

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Key information

Conditions

Kyphosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EOS X-rays

Radiation

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

8-meters walk test

Other

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

Primary outcomes

  1. Variations in spino-pelvic sagittal balance measured by EOS X-ray

    Time frame: 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 outcomes

  1. Position of the ground point projection of the center of mass

    Time frame: 1 hour

    Position of the ground point projection of the center of mass with and without corset

  2. vertical deceleration of the center of mass during the second part of the oscillating phase

    Time frame: 1 hour

    vertical deceleration of the center of mass during the second part of the oscillating phase with and without corset.

  3. Velocity of the center of mass during the second part of the oscillating phase

    Time frame: 1 hour

    Velocity of the center of mass during the second part of the oscillating phase with and without corset.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: VICON-SPINE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 24, 2018
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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