Diabetes MellitusNCT00167778
Prosthetic Components and Stability in Amputee Gait
A study testing Transverse plane rotation adaptor pylon and Rigid pylon in people with Diabetes Mellitus and Leg Injuries, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Leg Injuries, Traumatic Amputation
- What is being tested?
- Transverse plane rotation adaptor pylon and Rigid pylon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
About this study
Official title: Turning Corners: Prosthetic Components and Stability in Amputee Gait
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Leg Injuries, Traumatic Amputation
- Being tested
- Transverse plane rotation adaptor pylon, Rigid pylon
- Keywords
- Amputation, Amputee, Artificial limbs, Gait, Locomotion, Walking
- Medical subject headings
- Diabetes Mellitus, Leg Injuries, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse plane rotation adaptor pylonDevice
Potential future practice
Rigid pylonDevice
Current clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Novel prosthetic pylon Receives: Device: Transverse plane rotation adaptor pylon |
| Arm 2 | Active comparator | rigid pylon Receives: Device: Rigid pylon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurements were taken after wearing the study prostheses for three weeks.
Secondary outcomes (14)
Peak External Rotation Moment of the Outside Hip While Turning
Measured: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Outside Knee While Turning
Measured: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Outside Ankle While Turning
Measured: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Inside Hip While Turning
Measured: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Inside Knee While Turning
Measured: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Inside Ankle While Turning
Measured: 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)
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Measurements were taken after wearing the study prostheses for four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Glenn K. Klute, PhD, Principal investigator, VA Puget Sound Health Care System, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167778
- Sponsor's protocol ID
- A3611-R
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2005
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turning Corners: Prosthetic Components and Stability in Amputee Gait
- ClinicalTrials.gov ID
- NCT00167778
- Acronym / sponsor ID
- A3611-R
- Conditions
- Diabetes Mellitus, Leg Injuries, Traumatic Amputation
- Keywords
- Amputation, Amputee, Artificial limbs, Gait, Locomotion, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Transverse plane rotation adaptor pylonNovel prosthetic pylon |
| Arm 2 | Active comparator | Device: Rigid pylonrigid pylon |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Amputee Subjects:
- Non-amputee subjects participating in this investigation will meet similar inclusion criteria except for those related to prosthesis use.
Key exclusion criteria (4 listed)
- Amputee Subjects:
- Non-amputee subjects participating in this investigation will meet similar exclusion criteria except for those related to cause of amputation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse plane rotation adaptor pylonPotential future practice | Device | Arm 1 |
| Rigid pylonCurrent clinical practice | Device | Arm 2 |
Primary outcome
Local Dynamic Stability (Hip During Straight Walking)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
14 secondary outcomes
Peak External Rotation Moment of the Outside Hip While Turning
Time frame: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Outside Knee While Turning
Time frame: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Outside Ankle While Turning
Time frame: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Inside Hip While Turning
Time frame: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Inside Knee While Turning
Time frame: Measurements were taken after wearing the study prostheses for three weeks.
Peak External Rotation Moment of the Inside Ankle While Turning
Time frame: Measurements were taken after wearing the study prostheses for three weeks.
Activity Level
Time frame: One week
Six-minute Walk Distance
Time frame: Six minutes after wearing the study prostheses for four weeks.
Residual Limb Pain at Present?
Time frame: Measurements were taken after wearing the study prostheses for four weeks
Average Residual Limb Pain?
Time frame: Measurements were taken after wearing the study prostheses for four weeks.
Worst Residual Limb Pain?
Time frame: Measurements were taken after wearing the study prostheses for four weeks.
Least Residual Limb Pain?
Time frame: Measurements were taken after wearing the study prostheses for four weeks.
Pain Interference With Activities?
Time frame: Measurements were taken after wearing the study prostheses for four weeks.
How Bothersome Was Your Pain?
Time frame: Measurements were taken after wearing the study prostheses for four weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn K. Klute, PhD principal investigator
VA Puget Sound Health Care System, Seattle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse plane rotation adaptor pylon and Rigid pylon in people with Diabetes Mellitus and Leg Injuries, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Dynamic Stability (Hip During Straight Walking) (time frame: Measurements were taken after wearing the study prostheses for three weeks.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.