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临床试验/NCT03536403
NCT03536403已完成不适用

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

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Variations in spino-pelvic sagittal balance measured by EOS X-ray

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

healthy volunteers

Experimental

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

干预措施: EOS X-rays (Radiation)

healthy volunteers

Experimental

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

干预措施: 8-meters walk test (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Position of the ground point projection of the center of mass(1 hour)
  • vertical deceleration of the center of mass during the second part of the oscillating phase(1 hour)
  • Velocity of the center of mass during the second part of the oscillating phase(1 hour)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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