Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in metabolic cost of transport
研究概览
简要总结
The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic foot offers a reduction of the amount of oxygen used while walking, if stability is improved over current prosthetic feet, and whether the experimental device actually increases activity in amputees.
详细描述
Tensegrity Prosthetics' objectives are to test whether the K3 Promoter prosthetic foot affects walking efficiency or stability in trans-tibial unilateral amputees when compared to their current prostheses. The primary objectives are to determine if the experimental foot changes Cost of Transport (ml O2/kg/meter) or Stride Time Variability compared to an amputee's current prosthesis. Cost of Transport is an indicator of metabolic efficiency and Stride Time Variability indicates how likely a person is to fall. Oxygen consumption and stride time will be collected on a treadmill at the Gait and Motion Lab at the University of Colorado in Boulder.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •K2 or K3 classification based on current prosthetic device.
- •Males and females ≥ 18 years of age
- •Willing and able to sign informed consent
- •Able to read, write, and speak English
- •Documented to have a unilateral trans-tibial amputation
- •Actively utilizing a definitive prosthesis for at least 12 months
- •Utilizing current prosthetic foot for at least 3 months
- •Cognitively functional, in the opinion of the prosthetists'
- •Able to maintain a good gait on their existing limb for approximately 45 minutes
- •have a healthy residual limb in good condition
- •have a socket with a good, trouble-free fit on their residual limb
排除标准
- •Significant ulcers or infections associated with a compromised circulation of the other lower limb
- •Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
- •K0, K1or K4 Classification
- •Irreducible, pronounced knee or hip flexion contractures
- •Bilateral amputations
- •Use of a walker for ambulation
- •Severe arthritis that would limit the ability to stand without pain or discomfort or the subject's ability to ambulate is limited by symptoms other than the prothesis (e.g., shortness of breath, fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their ability to ambulate from the K3 Promoter to the extent that his or her walking would then be limited by a symptom other than the prothesis, the subject should not be enrolled
- •Any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial
- •Advanced neurologic disorder
- •Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
- •Use of medication that causes impaired balance or judgment
结局指标
主要结局
Change in metabolic cost of transport
时间窗: 30 and 60 days after the beginning of the protocol
Stride time variability
时间窗: 30 and 60 days after beginning of protocol
次要结局
- Amputee Mobility Predictor Questionnaire(Beginning and end of protocol)
- Actual change in activity as measured by a step counter(throughout protocol (60 days))