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Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System (VICON-SPINE)

U

University Hospital, Rouen

Status

Completed

Conditions

Kyphosis

Treatments

Radiation: EOS X-rays
Other: 8-meters walk test

Study type

Interventional

Funder types

Other

Identifiers

NCT03536403
2016/066/HP

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

healthy volunteers
Experimental group
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
Treatment:
Other: 8-meters walk test
Radiation: EOS X-rays

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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