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临床试验/NCT02921295
NCT02921295已完成不适用

A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis

Angela DeCandia1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2016年9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
发起方
入组人数
1
试验地点
1
主要终点
Average Speed for 10 Meter Walk Test

研究概览

简要总结

The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •bilateral transfemoral amputee
  • •own a pair of conventional stubby prosthesis with standard adaptation

排除标准

  • •dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)
  • •use of prosthesis that do not allow change of feet with standard adapters
  • •any medical condition that may put an individual in greater risk of injury than normal daily activity.

研究组 & 干预措施

Sidekick Stubbies

Active Comparator

Conventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses ("Sidekick" manufactured by College Park Ind.) were used as intervention

干预措施: Sidekick Stubbies (Device)

结局指标

主要结局

Average Speed for 10 Meter Walk Test

时间窗: 2 times throughout study completion (every 1 hour during the 2 hour protocol)

The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.

次要结局

  • Timed up and go Test Time(6 times throughout study completion (3 every 1 hour during the 2 hour protocol))
  • Gait Symmetry Index(2 times throughout study completion (every 1 hour during the 2 hour protocol))

研究者

发起方
Angela DeCandia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Angela DeCandia

Prosthetic & Orthotic Resident

University of Pittsburgh

研究点 (1)

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