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临床试验/NCT02989831
NCT02989831已完成不适用

The Effects of Random Vibrations on the Vibratory Perception Threshold of the Foot and Standing Balance in People With Diabetic Neuropathy

University Medical Center Groningen0 个研究点目标入组 40 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Difference in center of pressure displacement (balance) between the two conditions.

研究概览

简要总结

The purpose of this study is to investigate the effects of vibrating insoles on vibration perception threshold (VPT) and balance of people with diabetic neuropathy.

详细描述

Rationale: People with diabetes mellitus often suffer from polyneuropathy. Reduced somatosensation of the feet due to polyneuropathy is one of the major risk factors for ulceration at the plantar side of the feet and may often cause problems in balance. It has been shown that the application of a mechanical noise signal to the feet (a vibration with a random frequency) can reduce the sensation threshold and improve standing balance. However, techniques used in research so far have several problems that limit applicability in daily practice. New vibrating insoles have been developed that overcome these problems, but it is unknown if these insoles have the same effects.

Study population: Two samples of 20 consecutive patients with diabetes mellitus will be included. Patients will be included if their VPT is between 25 and 45V. Patients with a history of ulceration on MTP, halllux or heel region will be included in the first sample group. In the second sample group patients with no history of ulceration will be included. Patients with an ulceration or (a history of) amputation will be excluded in both groups.

Intervention: First, participants will be standing on vibrating insoles placed on a platform for the measurement of VPT. Secondly, participants will be standing on a force platform while wearing standardized shoes in which vibrating insoles are placed. The insoles are either turned on (i.e. random vibrations applied) or off (i.e. no random vibrations applied).

Main study parameters: Vibration perception threshold and centre of pressure displacements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Diabetes mellitus, type I or type II
  • Aged 18 years or older
  • Diagnosed with neuropathy
  • VPT between 25-45V
  • Understand Dutch or English
  • Is able to detect the stimulus at full power

排除标准

  • A history of neuropathic conditions other than diabetes mellitus
  • Problems with the somatosensory or motor system that affect balance or plantar sensation, not related to DM (for example: CVA)
  • Severe visual problems
  • Current ulcer
  • (a history of) amputation

结局指标

主要结局

Difference in center of pressure displacement (balance) between the two conditions.

时间窗: 1 minute

Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles

时间窗: One minute

次要结局

  • Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').(1 minute)
  • Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')(1 minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juha M Hijmans

PhD

University Medical Center Groningen

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