Back to resultsStudy of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System (VICON-SPINE)
Primary Purpose
Kyphosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOS X-rays
8-meters walk test
Sponsored by
About this trial
This is an interventional other trial for Kyphosis
Eligibility Criteria
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.
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
healthy volunteers
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT03536403
First Posted
April 26, 2018
Last Updated
June 26, 2020
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT03536403
Brief Title
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
Acronym
VICON-SPINE
Official Title
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy volunteers
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
EOS X-rays
Intervention Description
EOS X-rays is done with et without a kyphosis induced corset
Intervention Type
Other
Intervention Name(s)
8-meters walk test
Intervention Description
8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset
Primary Outcome Measure Information:
Title
Variations in spino-pelvic sagittal balance measured by EOS X-ray
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Position of the ground point projection of the center of mass
Description
Position of the ground point projection of the center of mass with and without corset
Time Frame
1 hour
Title
vertical deceleration of the center of mass during the second part of the oscillating phase
Description
vertical deceleration of the center of mass during the second part of the oscillating phase with and without corset.
Time Frame
1 hour
Title
Velocity of the center of mass during the second part of the oscillating phase
Description
Velocity of the center of mass during the second part of the oscillating phase with and without corset.
Time Frame
1 hour
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mourad OULD SLIMANE, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
We'll reach out to this number within 24 hrs