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Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

2008年3月21日 更新者:US Department of Veterans Affairs
The purpose of this study is to determine whether individuals with diabetic peripheral neuropathy can learn to change the way they walk in order to reduce the pressures underneath the feet, which may lead to a reduced risk of foot ulceration.

研究概览

详细说明

This study suggests that teaching a new strategy is beneficial to decrease the forefoot peak plantar pressure in individuals who are susceptible to plantar ulcerations. It has not, however, been studied whether these changes would be maintained long-term or if they had any effect on the ulceration rate. Additionally, no analysis of the amount of visual feedback necessary to elicit the desired motor pattern was discussed. It has been suggested that proprioception plays an integral role in the use of feedback to develop error-detection mechanisms by integrating visual feedback and kinesthetic variables. In the diabetic peripheral neuropathy subject population, proprioception and kinesthesia may be compromised. This may have effects on the ability of this population to maintain changes in inappropriate movement patterns. A significant portion of patients continue to develop plantar ulcers even with prescriptive footwear compliance, so gait training to change inappropriate patterns which result in the high plantar pressures may be critical to prevent ulceration.

Comparisons: Two groups of subjects will receive gait training, one group will receive feedback of performance while the other will only receive training, and one control group. Comparisons will include whether plantar pressures are decreased in the training groups, and if those changes are maintained long-term.

研究类型

介入性

注册 (预期的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • West Los Angeles、California、美国、90073
        • VA Greater Los Angeles Healthcare System, West LA

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Diagnosis of diabetes for at least one year.
  2. Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested (31;32)
  3. Age 50-80 years old
  4. Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
  5. No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions

Exclusion Criteria:

  1. Other non-diabetic causes of neuropathy by history
  2. Symptomatic peripheral vascular disease
  3. Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
  4. Visual problems not correctable with glasses or contact lens
  5. Passive range of motion limitations are described as:

    1. Hip flexion < 1000;
    2. Hip extension < 200;
    3. Knee flexion < 1250;
    4. Knee extension < 00 (unable to obtain full extension);
    5. Ankle plantar flexion < 250;
    6. Ankle dorsiflexion < 150
  6. Other systemic or local diseases that could interfere with walking assessment
  7. Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance
  8. Amputation in the lower extremities
  9. Terminal illness
  10. Severe obesity: BMI>30 kg/m2 (33)
  11. Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)
  12. Mini-mental status of <27 or diagnosis of dementia
  13. History of alcohol or drug abuse

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:1个

研究衡量的是什么?

主要结果指标

结果测量
Plantar Pressure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Karen Perell, PhD RKT、VA Greater Los Angeles Healthcare System, West LA

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年5月1日

初级完成 (实际的)

2006年9月1日

研究完成 (实际的)

2006年9月1日

研究注册日期

首次提交

2005年9月14日

首先提交符合 QC 标准的

2005年9月14日

首次发布 (估计)

2005年9月22日

研究记录更新

最后更新发布 (估计)

2008年3月24日

上次提交的符合 QC 标准的更新

2008年3月21日

最后验证

2008年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • A3117R

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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