Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167778
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2005-07-01
Brief Title:
Prosthetic Components and Stability in Amputee Gait
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Turning Corners Prosthetic Components and Stability in Amputee Gait
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1 discover the biomechanical strategies used and the stability of both intact individuals and trans-tibial amputees walking along a circular trajectory and
2 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
The specific aims of this investigation are to
1 discover the biomechanical strategies used and the stability of both intact individuals and trans-tibial amputees walking along a circular trajectory and
2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None