跳至主要内容
临床试验/NCT02366702
NCT02366702Unknown不适用

Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Southern California Institute for Research and Education1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3
试验地点
1
主要终点
Sagittal Plane Hip Moment

研究概览

简要总结

The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
  • All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
  • Subjects currently walk with entirely passive type prostheses daily.
  • Subjects walk without assistive devices OR with single point cane.
  • High-activity level walkers

排除标准

  • Ages < 18 or > 45 years
  • Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
  • Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
  • Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
  • Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.
  • Low-activity level walkers

结局指标

主要结局

Sagittal Plane Hip Moment

时间窗: During the stance phase of the gait cycle after two weeks of training with powered device.

Metabolic Cost of Transport

时间窗: 5 minutes of steady state walking after two weeks of training with powered device.

次要结局

未报告次要终点

研究者

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

Dana Craig

Health System Specialist

Southern California Institute for Research and Education

研究点 (1)

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