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临床试验/NCT02891928
NCT02891928已完成4 期

Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
25
试验地点
2
主要终点
Anteroposterior displacement amount of the center of pressure with regard to the center of mass.

研究概览

简要总结

The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

详细描述

Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with Type 2 Diabetes
  • Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand
  • Can walk without technical assistance
  • Age from 18 to 75
  • Having made his non-opposition

排除标准

  • Presence of ulceration of the foot (or a history of this type)
  • History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.

结局指标

主要结局

Anteroposterior displacement amount of the center of pressure with regard to the center of mass.

时间窗: Inclusion

Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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