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临床试验/NCT03688750
NCT03688750Unknown不适用

Impact of Different Shoe Heel Heights on Spinal Configuration During Different Phases of Menstrual Cycle

Cairo University0 个研究点目标入组 90 人开始时间: 2019年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
主要终点
kyphotic angle

研究概览

简要总结

90 healthy female subjects with regular menstrual cycle ,their ages ranged from 19-25 years,their BMI ranged from 18-25 will be participated in this study.

Formetric Raster Stereography will be used to assess spinal configuration while each participant wear shoes of different heel heights 2.5 cm (low),4.5 cm (moderate) and 7 cm (height) during early follicular and mid luteal phases of menstrual cycle.

详细描述

  • this study will be conducted on healthy females to investigate effect of different heel heights footwear on spine posture and pelvic position by using formetric 4 D analysis system which is a light-optical scanning method based on Video-Raster-Stereography (VRS). Accordingly, the system consists of a light projector which projects a line grid on the back of the patient which is recorded by an imaging unit. A computer software analyzes the line curvature that generates from it. the formetric provides comprehensive information about the whole body statics and posture in only one measuring process, e.g. spine curvature (lateral and frontal), vertebral rotation, and pelvic position.
  • There is generally no need for reflecting markers, because the anatomical fixed points Vertebra prominens (VP), Sacrum Point (SP), Dimple Left (DL) Dimple Right (DR) as well as the spinal center line and spinal rotation are automatically detected by the system. That allows a very time-saving and reliable examination procedure.
  • shoe characteristics: standard shoes will be used and designed to fit females in sizes ranging from 37-41 and different heel heights (2.5 cm low, 4,5 cm moderate and 7 cm high).
  • Descriptive statistics including mean and standard deviation will be applied for dependent variables and participant demographics. repeated measures analysis of variance will be implemented to detect the difference in dependent measures among three heel condition.

研究设计

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

入排标准

年龄范围
19 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Their ages ranged from 19-
  • Their BMI ranged from 18-25
  • They wear high heeled shoes occasionally for less than 10 H/week or not at all
  • they are able to wear high heel without pain.

排除标准

  • any female with spinal deviation,previous spinal surgeries,leg length discrepancy or foot deformities
  • Joint stiffness, ankle sprain
  • any case with orthopedic or neurological problems
  • Females with irregular menstrual cycle

结局指标

主要结局

kyphotic angle

时间窗: from 9/2018 to 6/2019

this the maximum angle measured between surface tangents of the upper inflection point in the vicinity of the vertebra prominence and the thoracic lumbar inflection point

pelvic tilting

时间窗: from 9/2018 to 6/2019

pelvic tilt refers as the difference in the height of the lumbar dimple based on horizontal plane ( transverse section)

trunk imbalance

时间窗: from 9/2018 to 6/2019

trunk imbalance is defined as the lateral deviation of the vertebra prominence from the mid line dimple

trunk inclination

时间窗: from 9/2018 to 6/2019

trunk inclination refers to a difference in the height between vertebra prominence and dimple mid line based on a vertical plane (sagittal section)

Lordotic angle

时间窗: from 9/2018 to 6/2019

this the maximum angle measured between surface tangents of the thoracic lumbar inflection point and lower lumbar-sacral inflection point

pelvic inclination

时间窗: from 9/2018 to 6/2019

it is calculated as the mean torsion of the dimple left and dimple right surface normals

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

HAhmed

lecturer of biomechanics

Cairo University

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