跳至主要内容
临床试验/NCT04836650
NCT04836650已完成不适用

Effect of Postural Metatarsal Bar Orthotic Element on Stability and Leg Muscular Activity. A Randomized Clinical Trial

Universidad de Extremadura1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月6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
40
试验地点
1
主要终点
Change of postural balance

研究概览

简要总结

Posturology allows to treat postural problems by using postural insoles, which will have an effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to stimulate specific receptors located on the sole of the foot, which will affect the muscular proprioception and modify the activation of the ascending muscle chains.

The hypothesis of this work is based on the fact that the use of postural insoles with a 2 millimeters metatarsal bar will influence the displacement of the center of pressure and the muscle activity of the leg when compared with a placebo insoles.

Participants will be healthy subjects and will be divided into two groups, control and experimental. Subjects in the control group will be given a pair of flat insoles (placebo insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal head.

Postural stability analysis will be performed with the force platform of the Biomechanics Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes open and closed under two situations, with footwear and with footwear and insoles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy subjects with no discomfort in gait
  • •Subjects with not muscle and skeletal diseases

排除标准

  • •Subjects with balance disorders, pain at legs
  • •Subjects with loss of balance

研究组 & 干预措施

Flat Insole (no metatarsal bar)

Placebo Comparator

Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles.

干预措施: Postural stability assessment with a force platform. (Diagnostic Test)

Flat Insole (no metatarsal bar)

Placebo Comparator

Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles.

干预措施: Muscular assessment with a electromyograph (Diagnostic Test)

Flat Insole (with 2 millimeters metatarsal bar)

Experimental

Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles with a 2 millimeters polyester resin metatarsal bar.

干预措施: Postural stability assessment with a force platform. (Diagnostic Test)

Flat Insole (with 2 millimeters metatarsal bar)

Experimental

Postural stability and electromyographic activity in the dominant leg will be assessed with the subject shod (closed clog) and with 1.2 millimeters flat polyester resin insoles with a 2 millimeters polyester resin metatarsal bar.

干预措施: Muscular assessment with a electromyograph (Diagnostic Test)

结局指标

主要结局

Change of postural balance

时间窗: From baseline to 10 minutes

The mediolateral and anteroposterior excursion of centre of pressures will be measured in millimeters with a force platform with and without the insoles

Change of muscular activity

时间窗: From baseline to 10 minutes

The muscular activity in gastrocnemius, soleus and tibialis anterioris will be measured as a percentage (%) with a surface electromyograph in one leg with and without the insoles

次要结局

未报告次要终点

研究者

发起方
Universidad de Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfonso Martínez Nova

Clinical Professor

Universidad de Extremadura

研究点 (1)

Loading locations...

相似试验

Effect of Postural Insoles on Stability and Leg... | 临床试验