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临床试验/NCT01803256
NCT01803256已完成不适用

The Measurement of Spine Dynamics During Gait for the Quantification of Intervention Outcomes in Patients With Different Pathologies

University Children's Hospital Basel1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).

研究概览

简要总结

The full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during gait in adolescents with and without structural spine deformities.

It has been hypothesized that the enhance trunk marker set:

  1. is a valid method for the measurement of spine deformations in the sagittal, frontal and indirectly transverse planes.
  2. is an applicable and reliable method for the measurement of spine dynamics during gait in healthy adolescents and in patients with structural deformities such as seen in scoliosis.
  3. is sensitive enough to distinguish the spinal movement pattern during gait measured in scoliosis patients from the one measured in healthy adolescents.

To verify the hypotheses, the following measurements will be carried out:

  • Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients.
  • Instrumented gait analysis with a standard full body marker set and the enhanced trunk marker set in scoliosis patients and healthy controls.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent idiopathic scoliosis
  • Able to walk a distance of minimum 50 meters barefoot and without any assistive device

排除标准

  • Other types of scoliosis (e.g. of neurological origin)
  • Previous treatment of scoliosis (conservative or surgery)
  • Injuries of the locomotor system which led to persistent deformities
  • Healthy controls:
  • Exclusion Criteria:
  • Any pathologies or diseases affecting the locomotor system
  • Injuries to the locomotor system which led to persistent deformities
  • Obesity (> 95th BMI-per-age percentile)
  • Leg length discrepancy (more than 1% of body height)

结局指标

主要结局

Validity of the enhanced trunk marker set for a static measurement of spinal kinematics (radiographic vs. motion analysis measurements).

时间窗: Data will be collected between April 2013 and June 2014. For each scoliosis patient, the radiographic measurements will be conducted immediately after inclusion and the motion analysis measurements within 48 hours of the radiographic measurements.

This primary endpoint will only be evaluated in scoliosis patients since healthy adolescents do not undergo radiographic measurements. Parameters include lumbar and thoracic spine curvature angles in the sagittal and frontal planes.

Reliability of the enhanced trunk marker set for the measurement of spinal kinematics in scoliosis patients and healthy adolescents during gait.

时间窗: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.

Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.

Differences in spinal kinematics between scoliosis patients and healthy adolescents during gait.

时间窗: Data will be collected between April 2013 and June 2014. Spinal kinematics during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.

Parameters include lumbar, thoracic and cervical spine curvature angles in the sagittal and frontal planes and segmental rotation angles in the transverse plane.

次要结局

  • Differences in spatio-temporal gait parameters and kinematics and kinetics of peripheral joints between scoliosis patients and healthy adolescents during gait.(Data will be collected between April 2013 and June 2014. Parameters during gait will be measured in each scoliosis patient / healthy adolescent within 48 hours of the radiographic examination.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Reinald Brunner, MD

Doctor in Charge, Neuro-Orthopedics

University Children's Hospital Basel

研究点 (1)

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