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Prosthetic Components and Stability in Amputee Gait

Primary Purpose

Diabetes Mellitus, Leg Injuries, Traumatic Amputation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transverse plane rotation adaptor pylon
Rigid pylon
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Amputation, Amputee, Artificial limbs, Gait, Locomotion, Walking

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • VA Puget Sound Health Care System, Seattle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Novel prosthetic pylon

rigid pylon

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Peak External Rotation Moment of the Outside Hip While Turning
Peak External Rotation Moment of the Outside Knee While Turning
Peak External Rotation Moment of the Outside Ankle While Turning
Peak External Rotation Moment of the Inside Hip While Turning
Peak External Rotation Moment of the Inside Knee While Turning
Peak External Rotation Moment of the Inside Ankle While Turning
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)
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.
Residual Limb Pain at Present?
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Average Residual Limb Pain?
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Worst Residual Limb Pain?
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Least Residual Limb Pain?
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Pain Interference With Activities?
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
How Bothersome Was Your Pain?
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."

Full Information

First Posted
July 1, 2005
Last Updated
July 28, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00167778
Brief Title
Prosthetic Components and Stability in Amputee Gait
Official Title
Turning Corners: Prosthetic Components and Stability in Amputee Gait
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Leg Injuries, Traumatic Amputation
Keywords
Amputation, Amputee, Artificial limbs, Gait, Locomotion, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Novel prosthetic pylon
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
rigid pylon
Intervention Type
Device
Intervention Name(s)
Transverse plane rotation adaptor pylon
Intervention Description
Potential future practice
Intervention Type
Device
Intervention Name(s)
Rigid pylon
Intervention Description
Current clinical practice
Primary Outcome Measure Information:
Title
Local Dynamic Stability (Hip During Straight Walking)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Knee During Straight Walking)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Ankle During Straight Walking)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)
Description
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.
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Secondary Outcome Measure Information:
Title
Peak External Rotation Moment of the Outside Hip While Turning
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Peak External Rotation Moment of the Outside Knee While Turning
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Peak External Rotation Moment of the Outside Ankle While Turning
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Peak External Rotation Moment of the Inside Hip While Turning
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Peak External Rotation Moment of the Inside Knee While Turning
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Peak External Rotation Moment of the Inside Ankle While Turning
Time Frame
Measurements were taken after wearing the study prostheses for three weeks.
Title
Activity Level
Description
Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter)
Time Frame
One week
Title
Six-minute Walk Distance
Description
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.
Time Frame
Six minutes after wearing the study prostheses for four weeks.
Title
Residual Limb Pain at Present?
Description
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Time Frame
Measurements were taken after wearing the study prostheses for four weeks
Title
Average Residual Limb Pain?
Description
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Time Frame
Measurements were taken after wearing the study prostheses for four weeks.
Title
Worst Residual Limb Pain?
Description
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Time Frame
Measurements were taken after wearing the study prostheses for four weeks.
Title
Least Residual Limb Pain?
Description
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Time Frame
Measurements were taken after wearing the study prostheses for four weeks.
Title
Pain Interference With Activities?
Description
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Time Frame
Measurements were taken after wearing the study prostheses for four weeks.
Title
How Bothersome Was Your Pain?
Description
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Time Frame
Measurements were taken after wearing the study prostheses for four weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn K. Klute, PhD
Organizational Affiliation
VA Puget Sound Health Care System, Seattle
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System, Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Prosthetic Components and Stability in Amputee Gait

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