Bio Leg: Advancing Mobility (BAM) (BAM)
Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg
研究概览
详细说明
Although microprocessor-controlled knees (MPK) such as the C-Leg have demonstrated clear benefits over non-microprocessor-controlled prosthetic knees, it remains unclear whether powered knee assistance provides additional advantages in movement quality, metabolic efficiency, and limb loading during walking adaptability tasks.
This study directly addresses this gap by comparing mobility using the Bio Leg to mobility with the C-Leg using outcome measures that reflect real-world mobility challenges.
By generating objective evidence on whether powered knee assistance improves biomechanics, efficiency, and stability beyond that achieved with an established MPK, this study will inform prosthetic prescription, rehabilitation strategies, and payer decision-making. Given the growing population of individuals living with transfemoral amputation, identifying technologies that support safe, efficient, and confident mobility has important implications for community participation, long-term musculoskeletal health, and quality of life.
This study uses a within-subject repeated-measures design in which each participant is assessed under two conditions: current prosthesis and the Bio Leg prosthesis. All primary and secondary outcomes will be analyzed as within-participant differences, with each participant serving as their own control.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Emily J Fox, PT, DPT, MHS, PhD
- 电话号码：904-742-2500
- 邮箱：ejfox@phhp.ufl.edu
研究联系人备份
- 姓名：Joshua C Encarnacion, BS
- 电话号码：904-345-8969
- 邮箱：Joshua.Encarnacion@brooksrehab.org
学习地点
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Florida
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Jacksonville、Florida、美国、32216
- 招聘中
- Brooks Rehabilitation
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults 40 to 70 years of age
- Unilateral transfemoral amputation > 1 year
- K3 or K4 ambulator (based on the K classification system) and able to walk with no greater assistances than a single point cane
- Current microprocessor-controlled prosthesis (C-leg) user with > 6 months experience and able to walk without a device of using a single point cane
- Able to give informed consent
Exclusion Criteria:
- Severe cardiovascular condition or other disease limiting study participation
- Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities
- Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation
- Pain that limits walking of participation in walking activities
- Current participation in rehabilitation to address walking function
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：C-Leg
The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.
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实验性的：Bio Leg
After the Bio Leg fitting, the participant will exclusively wear the Bio Leg knee component for an acclimation period that will be a minimum of 4 weeks and up to 6 depending on participant's schedule and comfort/ease of using the device.
Each participant will complete a minimum of 2 and up to 4 physical therapy sessions during the acclimation period.
These physical therapy sessions will involve standard physical therapy training for use of a prosthetic limb after amputation.
Following the acclimation period, the participant will complete the second assessment, which will mirror the first assessment.
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After completing biomechanics and clinical testing at Pre Assessment with their C-Leg, participants will be fitted with a Bio-Leg prosthesis at the prosthetist clinic.
The participant will train and use the Bio-Leg prosthesis during a 4-6 week acclimation period.
The participant will then complete the same biomechanics and clinical testing at Post Assessment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in 6-Minute Walk Test (6MWT)
大体时间：Baseline, 4-6 weeks
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The distance that a patient should walk based on their height, weight, age, and gender.
Performance assessment of walking endurance for 6 minutes.
An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
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Baseline, 4-6 weeks
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Change in Interlimb Symmetry (Ground Reaction Forces)
大体时间：Baseline, 4-6 weeks
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A direct measure of vertical ground reaction forces during the rising phase of a sit-to-stand task (measured in Newtons) using standard force plates embedded in the floor.
Increased symmetry in ground reaction forces between the lower limbs reflects improved equalization of weight distribution between the limbs.
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Baseline, 4-6 weeks
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Change in Metabolic Efficiency (O2/kg/m)
大体时间：Baseline, 4-6 weeks
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A direct measure assessed during the six-minute walk test.
Metabolic efficiency is determined by the energy cost of transport, defined as oxygen consumption per unit body weight and distance walked (O₂/kg/m), which accounts for the individual's weight and walking speed.
Improved metabolic efficiency reflects enhanced oxygen delivery and utilization during walking.
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Baseline, 4-6 weeks
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合作者和调查者
调查人员
- 首席研究员：Emily J Fox, PT, DPT, MHS, PhD、University of Florida & Brooks Rehabilitation
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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