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临床试验/NCT00985881
NCT00985881已完成不适用

Mechanically-induced Stochastic Resonance to Improve Amputee Gait

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2007年4月1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
入组人数
17
试验地点
2
主要终点
Gait variability

研究概览

简要总结

The purpose of this study is to determine if subthreshold vibration, when applied to the residual limb of a lower limb amputee through their prosthetic socket, can sufficiently enhance peripheral sensation to result in an improved ability to balance and walk.

详细描述

One of the many complications of diabetes is the loss of sensation in the feet. This sensory deficit can negatively impact the postural stability and mobility of non-amputees, since without feedback, it is simply more difficult to stand and walk. For lower limb amputees, the problem is compounded. These patients often have difficulty with prosthetic limb placement during maneuvering tasks, exhibit dramatic increases in the movement of their center of pressure during quiet standing, and both clinical and observational gait analysis reveal significant changes in their gait pattern relative to non-amputees.

The investigators' work proposes to explore the use of a novel prosthetic intervention for diabetic lower limb amputees. The investigators hypothesize that the intervention will sufficiently enhance proprioception to result in measurably improved postural stability and locomotor function for these patients. The intervention is based on a phenomenon known as stochastic resonance, whereby the application of sub-threshold vibration enables mechano-receptors previously unable to respond to stimuli to become more susceptible to depolarization. For Veterans with neuropathic proprioceptive losses, stochastic resonance may facilitate a functional response from subtle stimuli where gross inputs were formerly required.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Amputee subjects:
  • unilateral transtibial amputee of diabetic etiology,
  • have been fit with a prosthesis and have used a prosthesis for at least one year,
  • wear the prosthesis at least 4 hours per day,
  • ambulate without upper extremity aids,
  • have no history of injurious falls within the previous six months, and
  • touch sensation measured by a 10 gauge Semmes-Weinstein Monofilament in the dermatomes of their residual limb.

排除标准

  • Subjects will be excluded if:
  • they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics,
  • their residual limb is ulcerated, or
  • are currently using anticonvulsant medications for the treatment of neuropathic pain.

研究组 & 干预措施

Arm 1: stochastic resonance

Experimental

Mechanical stochastic resonance

干预措施: Custom prosthetic socket with mechanical vibrators (stochastic resonance) (Device)

Arm 2: current clinical practice

Other

Current clinical practice

干预措施: Conventional prosthetic socket (current clinical practice) (Device)

结局指标

主要结局

Gait variability

时间窗: Testing with and without stochastic resonance will occur within a single laboratory visit on one day

Self-selected walking speed (mean and standard deviation) in meters/second

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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