NCT05831696招募中不适用
Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- VO2 uptake - level ground
研究概览
简要总结
The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
详细描述
The Procedures include:
Initial Visit:
- Informed consent
- HIPAA authorization
- Determine/verify ambulation potential
- Take and record body measurements (height, weight, circumferences)
- Activities-Specific Balance Confidence (ABC) scale
- L.A.S.A.R. Posture alignment assessment with RxPx
Second Visit
- Fit with heartrate monitor and metabolic analyzer mask
- Treadmill Test (level-ground) with RxPx
- Rest
- Treadmill Test (incline) with RxPx
- Fit subject with PMPK
- L.A.S.A.R. Posture alignment assessment with PMPK
- Subject uses PMPK for one week as their primary prosthesis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
- •a body mass greater than 49Kg and less than 117Kg
- •18-75 years of age
- •Have an ambulation potential of K3 or K4
- •Use a prosthesis daily for walking or sports activities
- •No less than six months of experience with a prosthesis
- •No socket issues or changes in the last six weeks
- •No residual limb pain affecting functional ability.
排除标准
- •Cannot walk at different speeds (MCFL K0-K2)
- •Limb-loss below the knee or through the hip
- •More than one amputation.
- •Uses an assistive device for walking
- •Uncontrolled edema in leg compartments
- •Compromised skin of the residual limb or contralateral foot
- •Are 180 days or less post-amputation
- •Pregnant (self-reported)
研究组 & 干预措施
Powered Microprocessor-controlled Knee (PMPK)
Experimental
the "Power Knee" is a commercially available PMPK.
干预措施: Powered Microprocessor-controlled Knee (PMPK) (Other)
结局指标
主要结局
VO2 uptake - level ground
时间窗: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)
VO2 uptake during ambulation on a treadmill - level ground
VO2 uptake - incline
时间窗: Visit 2 (3 weeks post-study enrollment)
VO2 uptake during ambulation on a treadmill - 5 degree incline
次要结局
- Balance confidence(At Baseline Visit (study enrollment))
- Exertion(Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment))
研究者
研究点 (1)
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