- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536403
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System (VICON-SPINE)
June 26, 2020 updated by: University Hospital, Rouen
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rouen, France
- Rouen university hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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
|
EOS X-rays is done with et without a kyphosis induced corset
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
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.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 hour
|
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.
|
1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mourad OULD SLIMANE, MD, Rouen university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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