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临床试验/NCT01684501
NCT01684501已完成不适用

Comparing Active and Passive Ankle-foot Prostheses

Spaulding Rehabilitation Hospital1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
1
主要终点
Ankle power generation

研究概览

简要总结

The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

详细描述

Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • weigh more than 200 lbs
  • are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
  • have the ability to follow multi-step commands.

排除标准

  • score level D on the SIGAM mobility grade
  • have experienced 1 or more falls in the last month before the study
  • have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
  • the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
  • the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
  • Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation

结局指标

主要结局

Ankle power generation

时间窗: During the session trial (approx 10 minutes)

Ankle power derived using a camera-based motion capture system during walking

次要结局

  • Metabolic cost of ambulation(During the session trial (approx 10 minutes))

研究者

发起方
Spaulding Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Bonato

Director, Motion Analysis Laboratory

Spaulding Rehabilitation Hospital

研究点 (1)

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Comparing Active and Passive Ankle-foot Prostheses | 临床试验