Diabetes Mellitus Clinical Trial
Official title:
Turning Corners: Prosthetic Components and Stability in Amputee Gait
Verified date | July 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System, Seattle | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
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. | Measurements were taken after wearing the study prostheses for three weeks. | No |
Secondary | Peak External Rotation Moment of the Outside Hip While Turning | Measurements were taken after wearing the study prostheses for three weeks. | No | |
Secondary | Peak External Rotation Moment of the Outside Knee While Turning | Measurements were taken after wearing the study prostheses for three weeks. | No | |
Secondary | Peak External Rotation Moment of the Outside Ankle While Turning | Measurements were taken after wearing the study prostheses for three weeks. | No | |
Secondary | Peak External Rotation Moment of the Inside Hip While Turning | Measurements were taken after wearing the study prostheses for three weeks. | No | |
Secondary | Peak External Rotation Moment of the Inside Knee While Turning | Measurements were taken after wearing the study prostheses for three weeks. | No | |
Secondary | Peak External Rotation Moment of the Inside Ankle While Turning | Measurements were taken after wearing the study prostheses for three weeks. | No | |
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) | One week | No |
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. | Six minutes after wearing the study prostheses for four weeks. | No |
Secondary | 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 | No |
Secondary | 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. | No |
Secondary | 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. | No |
Secondary | 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. | No |
Secondary | 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. | No |
Secondary | 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. | No |
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