Turning Corners: Prosthetic Components and Stability in Amputee Gait
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Local Dynamic Stability (Hip During Straight Walking)
研究概览
简要总结
The biomechanics of changing direction while walking has been largely neglected despite its relevancy to functional mobility. In addition, an increased risk of injury can be associated with turning due to a decrease in stability. The objective of this study is to understand the biomechanics of turning gait in sample populations of intact and trans-tibial amputees and the capacity of prosthetic components to facilitate transverse plane movement. The clinical impact of this investigation is the development of interventions that increase functional mobility, stability and safety while turning.
The researchers propose to investigate three sets of hypotheses. The first set addresses the fundamental biomechanical mechanisms associated with walking along a circular trajectory, how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second set of hypotheses addresses dynamic stability and the potential influence of prosthetic interventions. The third set of hypotheses addresses how the rotational properties of the prosthetic pylon can influence comfort and mobility during daily activities.
详细描述
Most of what is known about how amputees walk and how the properties of prosthetic components affect their gait has been discovered through sagittal plane observations while amputees walk back and forth along a straight line. Abnormal limb loading, thought to be a principal factor in the occurrence of residual limb pain which in turn may cause instability and limit mobility, can certainly occur while walking in a straight line. However, the incidence of abnormal limb loading is likely amplified when performing more complex gait activities, such as turning or avoiding obstacles; activities that are so very common in everyday life.
The specific aims of this investigation are to:
- discover the biomechanical strategies used and the stability of both intact individuals and trans-tibial amputees walking along a circular trajectory and
- explore the effects of a prosthetic intervention on turning biomechanics, stability, comfort, and mobility.
We propose to investigate three sets of hypotheses:
The first set of hypotheses addresses the fundamental biomechanical mechanisms associated with walking along a circular trajectory, how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. We will conduct experiments to test three hypotheses related to achieving a change of heading, orientation, and balancing of centripetal forces necessary to walk along a circular trajectory.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Amputee Subjects:
- •be a unilateral trans-tibial amputee between the ages of 18 and 70,
- •weigh 220 pounds or less,
- •have been fit with a prosthesis and using a prosthesis for at least two years,
- •wear the prosthesis for at least 8 hours per day,
- •walk without crutches or a walker,
- •able to walk outside the home and in the community,
- •have not fallin within the last six months,
- •Non-amputee subjects participating in this investigation will meet similar inclusion criteria except for those related to prosthesis use.
排除标准
- •Amputee Subjects:
- •amputation due to tumor, have an active tumor, or are undergoing treatment of a tumor,
- •have pain in legs or any condition that interferes with walking.
- •Non-amputee subjects participating in this investigation will meet similar exclusion criteria except for those related to cause of amputation.
研究组 & 干预措施
Arm 1
Novel prosthetic pylon
干预措施: Transverse plane rotation adaptor pylon (Device)
Arm 2
rigid pylon
干预措施: Rigid pylon (Device)
结局指标
主要结局
Local Dynamic Stability (Hip During Straight Walking)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Knee During Straight Walking)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Ankle During Straight Walking)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)
时间窗: Measurements were taken after wearing the study prostheses for three weeks.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
次要结局
- Peak External Rotation Moment of the Outside Ankle While Turning(Measurements were taken after wearing the study prostheses for three weeks.)
- Peak External Rotation Moment of the Inside Hip While Turning(Measurements were taken after wearing the study prostheses for three weeks.)
- Least Residual Limb Pain?(Measurements were taken after wearing the study prostheses for four weeks.)
- Peak External Rotation Moment of the Inside Knee While Turning(Measurements were taken after wearing the study prostheses for three weeks.)
- Peak External Rotation Moment of the Inside Ankle While Turning(Measurements were taken after wearing the study prostheses for three weeks.)
- Six-minute Walk Distance(Six minutes after wearing the study prostheses for four weeks.)
- Pain Interference With Activities?(Measurements were taken after wearing the study prostheses for four weeks.)
- Peak External Rotation Moment of the Outside Hip While Turning(Measurements were taken after wearing the study prostheses for three weeks.)
- Peak External Rotation Moment of the Outside Knee While Turning(Measurements were taken after wearing the study prostheses for three weeks.)
- Activity Level(One week)
- Worst Residual Limb Pain?(Measurements were taken after wearing the study prostheses for four weeks.)
- Average Residual Limb Pain?(Measurements were taken after wearing the study prostheses for four weeks.)
- How Bothersome Was Your Pain?(Measurements were taken after wearing the study prostheses for four weeks.)
- Residual Limb Pain at Present?(Measurements were taken after wearing the study prostheses for four weeks)