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

NCT ID: NCT03536403

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2020-01-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

EOS X-rays

Intervention Type: RADIATION

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

8-meters walk test

Intervention Type: OTHER

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

Interventions

EOS X-rays

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

Intervention Type: RADIATION

8-meters walk test

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mourad OULD SLIMANE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2016/066/HP

Identifier Type: -

Identifier Source: org_study_id