跳至主要内容
临床试验/NCT05593991
NCT05593991已完成不适用

Immediate Repercussions on the Spine Posture From Passive Elevation of the Heels in Healthy Subjects: a Cross-sectional Study

Manusapiens2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
pelvic tilt angle

研究概览

简要总结

The goal of this cross-sectional study is to evaluate the immediate effect of heels elevation on the spine posture in a group of 100 healthy subjects (50 males, 50 females). The main question it aims to answer is weather high heels immediately affects spinal posture and pelvic position in the sagittal plane.

Participants will undergo an elevation of 3cm and then 7cm of both heels, while their spine posture will be examined by means of a rasterstereography device.

详细描述

The data collected by the rasterstereography device will be:

  1. pelvic tilt angle (PI), the angle determined by the vertical and the tangent to lumbosacral junction (ILS);
  2. ITL-ILS lordotic angle, measured between the tangents of the thoracolumbar junction (ITL) and the lumbosacral junction (ILS);
  3. ICT-ITL kyphotic angle, measured between the tangents of the cervicothoracic junction (ICT) and the thoracolumbar junction (ITL); see fig. 1;
  4. lumbar arrow (FL) horizontal distance in millimeters from the vertical line that passes through the kyphotic apex in the lumbar spine;
  5. cervical arrow (FC) (horizontal distance in millimeters from the virtual vertical plumb line that passes through the kyphotic apex in the cervical spine);
  6. antero-posterior flexion of the trunk (Trunk Inclination-TI) measured as the angle between the vertical line and the line passing through the prominent cervical vertebra (VP) to the line connecting the two dimples (DM); see fig. 2.

Participants will provide information on age, height and weight. A questionnaire will be administered to standardize the types of high-heeled shoes used and to verify their frequency of use.

Evaluation Protocol

  1. sample 1: barefoot neutral position;
  2. sample 2: barefoot neutral position;
  3. sample 3: 3 cm rise under both heels;
  4. sample 4: 7 cm rise under both heels.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All healthy subjects.

排除标准

  • structural or neurological abnormalities that would prevent standing for 5 seconds with their heels on a 7 cm high plinth;
  • regular users of shoes with 7 cm high heels (or more), with a frequency of more than twice a week and / or more than 3 hours / week;
  • low back pain in the past 30 days.

结局指标

主要结局

pelvic tilt angle

时间窗: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

the angle between the vertical and the tangent to the lumbosacral junction

lordotic angle

时间窗: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

measured between the tangents of the thoracolumbar junction and the lumbosacral junction;

kyphotic angle

时间窗: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

measured between the tangents of the cervicothoracic junction and the thoracolumbar junction;

lumbar arrow

时间窗: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

horizontal distance in millimeters of the lumbar spine from the virtual vertical line that passes through the kyphotic apex;

cervical arrow

时间窗: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

horizontal distance in millimeters of the cervical spine from the virtual vertical line that passes through the kyphotic apex;

anteroposterior trunk flexion

时间窗: 5 seconds for each measured condition (barefoot, 3 cm heels elevation, 7 cm heels elevation)

measured as the angle between the vertical and the line that passes through the prominent cervical vertebra and the line connecting the two dimples.

次要结局

未报告次要终点

研究者

发起方
Manusapiens
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验