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临床试验/NCT06433648
NCT06433648招募中不适用

Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Amputee Mobility Predictor with Prosthesis (AMPRO) score

研究概览

简要总结

The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees.

Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.

Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.

Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).

Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.

详细描述

Amputation of the lower limb causes profound disability, significantly limiting mobility, independence, and the ability to pursue employment or leisure activities. Nearly 90% of all lower limb amputations in the United States occur in older persons, mostly due to vascular disease, and this population is expected to triple by 2050. After lower limb loss, individuals walk more slowly and more asymmetrically are less stable, and expend more metabolic energy during walking than persons with intact limbs. Even when using state-of-the-art microprocessor-controlled prostheses (typically a microprocessor knee with a passive ankle), persons with transfemoral amputations expend approximately 60% more energy than able-bodied individuals during ambulation. In addition to the physical limitations caused by the amputation, the increased energy requirements affect performance of everyday activities, including getting up out of a chair or off the toilet, or stepping up or down a curb.

Most commercially available prosthetic legs are passive. The movement of a passive prosthetic joint relies on the properties of its mechanical components, such as hydraulic or pneumatic valves or sliding joints, together with compensatory adjustments made by the user. Since these computerized prostheses are passive, the user cannot efficiently negotiate stairs, an incline, or the numerous other functions that require net knee and/or ankle power.

Powered prostheses can actively generate joint torque, allowing easy and efficient performance of more demanding activities, such as ascending stairs and hills. Powered knees and ankles, may allow for better outcomes in both older and younger individuals with transfemoral amputation; this powered componentry may enable more energy efficient walking, allow users to stand up from a seated position with ease, and enable them to walk across more challenging terrains-such as up and down hills, ramps, and stairs-safely and with more normal and symmetric gait kinematics and kinetics.

This study will demonstrate the functional benefits of adding power at an individual joint. This knowledge will be critical for prioritizing future device development and will provide valuable information for clinicians and individuals on selecting appropriate componentry for transfemoral K2 amputees.

研究设计

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

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-95
  • A unilateral transfemoral amputation
  • At least 6 months since definitive prosthesis fitting
  • Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.
  • Medically cleared by physician to participate in study
  • English speaking

排除标准

  • Weight greater than 250 pounds
  • Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
  • Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
  • Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.

结局指标

主要结局

Amputee Mobility Predictor with Prosthesis (AMPRO) score

时间窗: Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.

The AMPRO measures the ambulatory potential of lower limb amputees. It is used to assess functional mobility through a standardized sequence of mobility tests while using a prosthesis. Individual tasks are scored and combined, resulting in a total assessment score out of a possible 47; the minimum score is zero. Higher scores indicate better mobility. The AMPPRO is a reliable performance measure that has been validated for those with lower limb loss; it measures several functional mobility tasks that are needed during activities of daily living; it has been used to identify limitations in prosthetic mobility, including tasks that require both vertical mobility (sit/stand), horizontal mobility (walking), and balance. The AMPPRO scores have been shown to differentiate between Medicare K-levels and to provide information to guide therapeutic exercise techniques and document change after clinical instruction.

次要结局

  • Metabolic Testing(Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38)
  • Timed Up and Go (TUG)(Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.)
  • 6 Minute Walk Test (6MWT)(Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.)
  • Four Square Step Test (FSST)(Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.)

研究者

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

Levi Hargrove

Scientific Chair, Center for Bionic Medicine

Shirley Ryan AbilityLab

研究点 (2)

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