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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.
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:
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.
The second set of hypotheses seeks to identify whether trans-tibial amputees with a rigid pylon are more unstable during a turning task than non-amputees and whether or not the rotation adaptors enhance stability. We will conduct experiments to calculate an index of dynamic stability that measures the rate at which a person can respond to a perturbation and return to a stable gait pattern.
The third set of hypotheses addresses how the rotational properties of the prosthetic pylon can influence comfort and mobility during daily activities. To measure comfort and mobility, we will solicit questionnaire responses and step count measures from amputees after a one-month period of wearing a rigid pylon and after a one-month period of wearing a transverse plane rotation adaptor (within-subject comparison). In addition to these field measurements, we will also compare the distance traveled during a six-minute walk. Patient opinions about their prosthesis and mobility measures over long periods of time can play a significant role in prosthesis evaluation.
For veteran amputees who experience discomfort and increased risk for residual limb skin problems, it seems reasonable to suppose that these problems might occur when walking along a curved trajectory rather than just a straight line. The joint forces and moments of turning may differ significantly from those exhibited while walking in a straight line. The proposed research will create a new knowledge base with which to understand prosthetic intervention effectiveness. The immediate clinical impact for the trans-tibial amputee is the determination if transverse plane rotational adapter pylons can improve their comfort, mobility, and stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Novel prosthetic pylon |
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| Arm 2 | Active Comparator | rigid pylon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transverse plane rotation adaptor pylon | Device | Potential future practice |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Local Dynamic Stability (Hip During Straight Walking) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Knee During Straight Walking) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Ankle During Straight Walking) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Amputee Subjects:
Non-amputee subjects participating in this investigation will meet similar inclusion criteria except for those related to prosthesis use.
Exclusion Criteria:
Amputee Subjects:
Non-amputee subjects participating in this investigation will meet similar exclusion criteria except for those related to cause of amputation.
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| Name | Affiliation | Role |
|---|---|---|
| Glenn K. Klute, PhD | VA Puget Sound Health Care System, Seattle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System, Seattle | Seattle | Washington | 98108 | United States |
The prostheses used in this study were built and aligned by a certified and licensed prosthetist prior to beginning starting the protocol. 12 individuals provided informed consent. 1 withdrew prior to starting for personal reasons. 1 withdrew due to unrelated back pain after being fit with both study prostheses and starting with the rigid pylon.
Recruitment for this study was conducted at the VA Puget Sound Health Care System (Seattle VA hospital). Recruitment began on May 18, 2006. The study was closed to enrollment on April 24, 2008.
Data was not collected on the order in which participants received each study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amputee | This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Amputee | Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Dynamic Stability (Hip During Straight Walking) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amputee | Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol. |
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Our sample population consisted of community ambulators whose results may not generalize to all lower limb amputees.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn K. Klute, PhD | Dept. of Veterans Affairs, Rehabilitation Research & Development Service | 206-277-6724 | Glenn.Klute@va.gov |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007869 | Leg Injuries |
| D000673 | Amputation, Traumatic |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Rigid pylon |
| Device |
Current clinical practice |
|
| Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn) | 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. | Measurements were taken after wearing the study prostheses for three weeks. |
| 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. |
| 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. |
| Activity Level | Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter) | One week |
| Six-minute Walk Distance | Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps. | Six minutes after wearing the study prostheses for four weeks. |
| Residual Limb Pain at Present? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | Measurements were taken after wearing the study prostheses for four weeks |
| Average Residual Limb Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | Measurements were taken after wearing the study prostheses for four weeks. |
| Worst Residual Limb Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | Measurements were taken after wearing the study prostheses for four weeks. |
| Least Residual Limb Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | Measurements were taken after wearing the study prostheses for four weeks. |
| Pain Interference With Activities? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | Measurements were taken after wearing the study prostheses for four weeks. |
| How Bothersome Was Your Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | Measurements were taken after wearing the study prostheses for four weeks. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Amputation Etiology | Number | participants |
|
| Torsion adapter stiffness | Settings on the torsion adapter ranged from -5 to 5 in integer increments, where 5 was the stiffest possible setting. | Mean | Standard Deviation | units on a scale |
|
| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | m |
|
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
| OG001 | Torsion Adapter Pylon | A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface. |
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| Primary | Local Dynamic Stability (Knee During Straight Walking) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Ankle During Straight Walking) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Primary | Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn) | 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. | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | dimensionless | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Peak External Rotation Moment of the Outside Hip While Turning | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | N*mm/kg | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Peak External Rotation Moment of the Outside Knee While Turning | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | N*mm/kg | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Peak External Rotation Moment of the Outside Ankle While Turning | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | N*mm/kg | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Peak External Rotation Moment of the Inside Hip While Turning | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | N*mm/kg | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Peak External Rotation Moment of the Inside Knee While Turning | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | N*mm/kg | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Peak External Rotation Moment of the Inside Ankle While Turning | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | N*mm/kg | Measurements were taken after wearing the study prostheses for three weeks. |
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| Secondary | Activity Level | Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter) | Each participant wore both study prostheses. | Posted | Mean | Standard Error | Steps/day | One week |
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| Secondary | Six-minute Walk Distance | Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps. | Each participant wore both study prostheses. | Posted | Mean | Standard Error | m | Six minutes after wearing the study prostheses for four weeks. |
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| Secondary | Residual Limb Pain at Present? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | 10 participants wore both study prostheses but only 7 participants presented with pain. | Posted | Mean | Standard Error | units on a scale | Measurements were taken after wearing the study prostheses for four weeks |
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| Secondary | Average Residual Limb Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | 10 participants wore both study prostheses but only 7 participants presented with pain. | Posted | Mean | Standard Error | units on a scale | Measurements were taken after wearing the study prostheses for four weeks. |
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| Secondary | Worst Residual Limb Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | 10 participants wore both study prostheses but only 7 participants presented with pain. | Posted | Mean | Standard Error | units on a scale | Measurements were taken after wearing the study prostheses for four weeks. |
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| Secondary | Least Residual Limb Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | 10 participants wore both study prostheses but only 7 participants presented with pain. | Posted | Mean | Standard Error | units on a scale | Measurements were taken after wearing the study prostheses for four weeks. |
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| Secondary | Pain Interference With Activities? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | 10 participants wore both study prostheses but only 7 participants presented with pain. | Posted | Mean | Standard Error | units on a scale | Measurements were taken after wearing the study prostheses for four weeks. |
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| Secondary | How Bothersome Was Your Pain? | The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference." | 10 participants wore both study prostheses but only 7 participants presented with pain. | Posted | Mean | Standard Error | units on a scale | Measurements were taken after wearing the study prostheses for four weeks. |
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| 0 |
| 12 |
| 0 |
| 12 |
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| D014947 | Wounds and Injuries |