Metabolic and Biomechanical Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Obstacle Course Completion Time
研究概览
简要总结
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.
详细描述
Specific Aims
- Compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments.
- Compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups.
Hypotheses:
Prosthetic feet with shock absorbing and torsional features will perform better in field activities. Prosthetic feet with high energy return and low mass will perform better during treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects.
Relevance:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(Amputees):
- •Unilateral transtibial amputee ambulating on a K4 prosthesis for >1yr
- •K4 functional level
- •Currently active duty military or other uniformed service (e.g. police), recently separated Veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.)
- •Schedule availability and willingness to comply with study protocols
- •Aged < 45 years
- •Medical clearance, within the last 6 months, for participation in vigorous physical activities
- •Inclusion Criteria (Non-amputees)
- •Currently active duty military, ROTC, or other uniformed service (e.g. police) or recently separated Veteran, or highly accomplished recreational athlete (e.g. marathoner)
- •Schedule availability and willingness to comply with study protocols
- •Aged < 45 years
- •Medical clearance, within the last 6 months, for participation in vigorous physical activities
排除标准
- 未提供
研究组 & 干预措施
Prosthetic foot 1 (Ossur Variflex)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).
干预措施: Ossur Variflex prosthetic foot (Device)
Prosthetic foot 2 (Ossur Ceterus)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus).
干预措施: Ossur Ceterus prosthetic foot (Device)
Prosthetic foot 3 (Endolite Elite Blade)
This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade).
干预措施: Endolite Elite Blade prosthetic foot (Device)
Non-amputee controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
结局指标
主要结局
Obstacle Course Completion Time
时间窗: 21 days total (7days per prosthetic foot condition)
Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.
Bioenergetics Between Feet Components 21 Days After Fitting Prostheses
时间窗: 21 days total (7days per prosthetic foot condition)
Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.
次要结局
未报告次要终点
研究者
William Quillen
Associate Dean & Professor
University of South Florida