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临床试验/NCT02383446
NCT02383446已完成不适用

Evaluation of the Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees

Sheba Medical Center0 个研究点目标入组 13 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
状态
已完成
入组人数
13
主要终点
Center of pressure movement

研究概览

简要总结

Background:

Trauma is the second most common factor for transtibial amputations, just after vascular background. Traumatic amputees generally function better than amputees due to vascular background. The type of prosthetic foot fitted to the patient depends on his mobility and functional level, and significantly influences his stability and gait symmetry. A prosthetic foot with a hydraulic ankle provides significant advantages for high level functioning amputees: decrease of loads in the residuum, improvement in symmetry and generally gait pattern that is closer to natural. The hydraulic prosthetic foot has recently been upgraded to include computerized control over the ankle movement, using input from an array of sensors inside the foot. Studies have demonstrated decrease in energy consumption and gait pattern that is more similar to healthy people. However, hydraulic feet with and without computer control have not been compared. Furthermore, the effects of a computerized foot on various important factors have not been investigated yet, e.g. loads in the residuum, the movement of the center of pressure and the patient's satisfaction.

Research objectives:

To compare between hydraulic prosthetic feet, with and without computerized control. The comparison will be made while walking on flat or inclined surfaces (positive or negative inclination). Differences in gait parameters, loads inside the residuum, center of mass movement and patient's satisfaction will be quantified.

Research hypothesis: Using a computerized prosthetic foot will provide better mobility performances: improved gait factors and center of pressure movement, decrease internal loads in the residuum and increase patient's satisfaction.

Research design:

Clinical controlled research with research group(amputees) and control group (healthy).

详细描述

The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age: 20 to 70 years old
  • Traumatic unilateral Transtibial Amputee
  • Using Echelon foot prosthesis for at least 6 months
  • K level 3 or 4

排除标准

  • Injury of the sound limb that compromises the gait of the amputee.

结局指标

主要结局

Center of pressure movement

时间窗: 2 to 6 weeks

次要结局

  • Pressure on the skin and internal loads in the residuum (measured by a surface pressure mapping technology).(2 to 6 weeks)
  • Grade in questionnaire for prosthetic evaluation.(2 to 6 weeks)

研究者

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

Dr. Itzhak Siev-Ner

Head of The Department of Orthopedic Rehabilitation

Sheba Medical Center

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