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临床试验/NCT02542761
NCT02542761已完成不适用

Comparative Performance of Dynamic Elastic Response Feet

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
10
试验地点
2
主要终点
Peak Ankle Dorsiflexion During Stance

研究概览

简要总结

The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite.

详细描述

Recently, a new type of prosthetic foot has appeared on the market. This device is composed of a fiberglass composite material. Knowledge is lacking regarding the performance characteristics of this new device. Comprehensive studies are needed to form a solid basis for prosthetic prescription. The current study sought to understand the experience of community-living, transtibial amputees using this prosthetic foot. Specifically, the biomechanical performance of this device were compared to existing conventional dynamic elastic response (DER) technology in a controlled laboratory setting. The investigators hypothesized that the fiberglass composite material provided more energy return and improved ankle kinematics performance.

The study design was a repeated measures cross-over trial whereby only the prosthetic foot was changed. Each subject was tested using their current carbon-fiber energy storage and return prosthetic foot (CFPF) and the fiberglass composite energy storage and return prosthetic foot (Rush, Ability Dynamics) (FPF). Half of the subjects began the study on the CFPF while the other half began on the FPF. All types of CFPF were used in this study. Each subject was given an acclimation period (about 4 weeks) before testing, which was consistent with other similar studies. The same socket and suspension were used throughout the study in order to eliminate these confounding variables.

A 10 camera, high resolution motion capture system with a set of 51 reflective markers was used to capture whole-body motion. Three-dimensional marker trajectory data was collected at 120 Hz and filtered using a fourth-order Butterworth low-pass filter with a cutoff frequency of 8 Hz. The standard Helen Hayes marker set and some additional markers were applied to the subject. Additional markers included an anterior pylon marker, medial pylon marker, lateral pylon marker, right and left medial calcaneus markers, and right and left lateral calcaneus markers. In addition, left and right medial knee markers were used for establishing the knee joint centers and were then removed for the walking trails. Subjects wore standard laboratory athletic shoes for all walking trials. All of the markers associated with the foot were placed on the outside of the subject's shoes.

Following the application of the reflective marker set, the subject performed tests while walking over level ground at a self-selected and normalized speed as well as up and down a 10 degree inclined ramp. The normalized speed controlled for leg length by normalizing to a Froude (Fr) number of 0.25 where Fr = v^2/gl, and v is the walking speed, g is the gravitational constant, and l is the leg length using the greater trochanter height as leg length. Timing gates were used to control the walking speed. Simultaneously, ground reaction force data was collected from force plates at a sampling rate of 600 Hz. Data from these force plates was time-synchronized with the motion cameras. The ramp had a force plate embedded within the ramp.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Unilateral transtibial amputee
  • Currently using a carbon fiber prosthetic (DER) foot for at least the last 6 months
  • Stable stump volume over the past 6 months
  • Medicare Functional Classification Level K3 or K4

排除标准

  • Neuromuscular problems such as previous stroke or contralateral amputation
  • Use of gait aids for ambulation
  • Undergoing dialysis
  • Poor prosthetic socket fit or stump problems (e.g., skin breakdown)

研究组 & 干预措施

CFPF first, then FPF

Experimental

After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF).

干预措施: Fiberglass Composite foot (Device)

CFPF first, then FPF

Experimental

After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF).

干预措施: Carbon Fiber Composite Foot (Device)

FPF first, then CFPF

Experimental

After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF).

干预措施: Fiberglass Composite foot (Device)

FPF first, then CFPF

Experimental

After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF).

干预措施: Carbon Fiber Composite Foot (Device)

结局指标

主要结局

Peak Ankle Dorsiflexion During Stance

时间窗: After approximate 4 week acclimation period

The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.

次要结局

  • Peak Knee Flexion During Swing(After approximate 4 week acclimation period)
  • Peak Ankle Plantar Flexor Moment During Stance(After approximate 4 week acclimation period)
  • Peak Ankle Power Generation(After approximate 4 week acclimation period)
  • Time of Peak Knee Flexion During Swing(After approximate 4 week acclimation period)
  • Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)(After approximate 4 week acclimation period)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenton R. Kaufman, Ph.D.

PI

Mayo Clinic

研究点 (2)

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