跳至主要内容
临床试验/NCT06276972
NCT06276972进行中(未招募)不适用

The Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical Parameters in Scoliotic Adolescents. A Cross Sectional Study

Delta University for Science and Technology1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2023年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
89
试验地点
1
主要终点
Coronal balance

研究概览

简要总结

To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

详细描述

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. Numerous studies deal with the aetiology of the disease, X-ray morphology and classification of curvatures and how the disorder disrupts the spinal biomechanical balance, however the disorder is a complex three-dimensional deformity that affects the body as a whole, and these effects must not be overlooked. No cross-section studies were found assessing the connection between sagittal or coronal balance and the biomechanical parameters of the lower extremity.

HYPOTHESES:

Null hypothesis There are no statistically significant relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents.

RESEARCH QUESTION:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adolescents with age 10-18 years
  • complaining of dorsolumbar scoliosis
  • curves (apex lies between D10 and L4)
  • curve magnitudes greater than 15 degrees and less than 90
  • using or not using brace
  • all maturity levels (Risser = 0-5)

排除标准

  • Other types of scoliosis ; congenital or neuromuscular
  • Current physical therapy or medical treatment for scoliosis,
  • Contracture or surgery affecting the lumbar spine or lower limbs
  • Pathologies such as inflammatory diseases
  • congenital anomalies
  • Neurological disorders like cerebral palsy or ataxia
  • dislocations
  • visual or auditory problems

结局指标

主要结局

Coronal balance

时间窗: at the enrollment

Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )

length of the the tibia and femur

时间窗: at the enrollment

The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)

lower limb mechanical axis; and mechanical axis deviation

时间窗: at the enrollment

The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).

Cobb's angle

时间窗: at the enrollment

Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)

tibiofemoral angle

时间窗: at the enrollment

The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)

knee joint line convergence angle

时间窗: at the enrollment

The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)

次要结局

未报告次要终点

研究者

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

Omar Mohamed Ali Elabd

Lecturer of Orthopedic Physical Tehrapy

Delta University for Science and Technology

研究点 (1)

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