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临床试验/NCT00223782
NCT00223782已完成不适用

Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2004年5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
150
试验地点
2
主要终点
Plantar Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of diabetes for at least one year.
  • 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)
  • Age 50-80 years old
  • Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
  • No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions

排除标准

  • Other non-diabetic causes of neuropathy by history
  • Symptomatic peripheral vascular disease
  • Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
  • Visual problems not correctable with glasses or contact lens
  • Passive range of motion limitations are described as:
  • Hip flexion < 1000;
  • Hip extension < 200;
  • Knee flexion < 1250;
  • Knee extension < 00 (unable to obtain full extension);
  • Ankle plantar flexion < 250;
  • Ankle dorsiflexion < 150
  • Other systemic or local diseases that could interfere with walking assessment
  • Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance
  • Amputation in the lower extremities
  • Terminal illness
  • Severe obesity: BMI>30 kg/m2 (33)
  • Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)
  • Mini-mental status of <27 or diagnosis of dementia
  • History of alcohol or drug abuse

结局指标

主要结局

Plantar Pressure

次要结局

未报告次要终点

研究者

申办方类型
Fed

研究点 (2)

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