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临床试验/NCT04809441
NCT04809441已完成不适用

Baropodometric Parameters Variation With Body Weight Loss: a Prospective Cohort Study

Fundacion Podoactiva1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年6月10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
43
试验地点
1
主要终点
Cop change

研究概览

简要总结

Background: One of the major public health problems of the 21st century is obesity. Baropodometry is commonly used to determine specific loads on the plantar surface of the foot and the comportment of the body center of pressure (CoP). To evaluate the redistribution of the baropodometric parameters: static and dynamic plantar pressures and antero - posterior CoP, by decreasing body weight.

Methods: A sample of 43 overweight subjects (24 male, 19 female) would be recruited for the study. A hypocaloric diet would be designed with the aim to reduce participants body weight. The baropodometric exam would performed in two occasions: weight 1 - Session 1 and weight 2 - Session 2, when participants lost between 12 and 18 kg. The foot would be divided in 9 areas: heel, midfoot, 5 metatarsal heads (MTHs), Hallux, 2-5 toes. The Footwork® pressure platform would be used to carry out the evaluation.

详细描述

Scientific Background Obesity is in one of the major public health problems of the 21st century and its prevalence has tripled in many European countries in the last decades. It is a strongly problem associated with a lower quality of life, as well as with the development of serious chronic metabolic, cardiac and circulatory pathologies and musculoskeletal disorders. Quantitative data showed that excessive body weight negatively effects on standing and walking.

Plantar pressure measurement is commonly used to determine specific loads on the plantar surface of the foot. There are many case studies that assess pressures of the normal foot and try to establish patterns of pathological pressures. The CoP represents the average of all the weight that is in contact with the surface of the floor and is expressed as the point where the vector of the vertical reaction forces of the soil is located.

In the literature it can be found how body weight influences on plantar pressure data and on the position of the CoP. Excesses of body weight has shown to have negative structural consequences in the feet and lower limbs. Obesity is also related with an anterior displacement of the CoP, since the instability in obese people, associated to weight increasing, seems to be determinant with CoP in an anterior position.

Computerized baropodometry is helpful for foot diseases diagnosis, foot function evaluation and to follow-up the treatment. It has been practiced to determine specific weight parameters in obese adults, among others. Nonetheless, there are not in the literature specific studies that have analyzed by computerized baropodometry how plantar pressures and CoP improve by decreasing body weight in obese adults.

Objective The present research wanted to evaluate plantar pressures and antero - posterior CoP improvement by decreasing body weight in static and dynamic baropodometry data collection in obese adults.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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
否

入选标准

  • •Overweight subjects
  • •between 18 and 65 years old
  • •medical weight loss indicated
  • •no lower limb or spine pathology that might affect normal gait, nor structural or functional deformities in the feet.

排除标准

  • •not comply inclusion criteria
  • •reported pain in their feet within the previous 6 months
  • •had any previous foot surgery

研究组 & 干预措施

Weight loss group

Experimental

Participants were rigorously evaluated by the same endocrine doctor and podiatrist at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant had lost between 11-12% of its corporal weight. Therefore, we obtained 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.

干预措施: Diet change (Other)

结局指标

主要结局

Cop change

时间窗: baseline, before procedure and immediately after the procedure

Displacement from Session 1 to Session 2 position of the Center of pressures obteined with the pressure platform

Weight change

时间窗: baseline, before procedure and immediately after the procedure

Weight change would be measured at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant lost between 11-12 percent of its corporal weight. Therefore, we will obtain 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.

Static pressure change

时间窗: baseline, before procedure and immediately after the procedure

For the static pressure, participants would be asked to stand in the center of the plantar pressure platform for 5 seconds, with their arms on either side of the body in a natural position looking straight ahead. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean static pressures would be measured.

Dynamic pressure change

时间窗: baseline, before procedure and immediately after the procedure

For the dinamic pressure, participants would be asked to walk throught the plantar pressure platform at they preferred speed. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean dynamic pressures would be measured.

次要结局

未报告次要终点

研究者

发起方
Fundacion Podoactiva
申办方类型
Other
责任方
Sponsor

研究点 (1)

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