Prosthetic Components and Stability in Amputee Gait

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00167778
First received: July 1, 2005
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Leg Injuries
Traumatic Amputation
Device: Transverse plane rotation adaptor pylon
Device: Rigid pylon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Turning Corners: Prosthetic Components and Stability in Amputee Gait

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Local Dynamic Stability (Hip During Straight Walking) [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
  • Peak External Rotation Moment of the Outside Knee While Turning [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
  • Peak External Rotation Moment of the Outside Ankle While Turning [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
  • Peak External Rotation Moment of the Inside Hip While Turning [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
  • Peak External Rotation Moment of the Inside Knee While Turning [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
  • Peak External Rotation Moment of the Inside Ankle While Turning [ Time Frame: Measurements were taken after wearing the study prostheses for three weeks. ] [ Designated as safety issue: No ]
  • Activity Level [ Time Frame: One week ] [ Designated as safety issue: No ]
    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 [ Time Frame: Six minutes after wearing the study prostheses for four weeks. ] [ Designated as safety issue: No ]
    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? [ Time Frame: Measurements were taken after wearing the study prostheses for four weeks ] [ Designated as safety issue: No ]
    The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."

  • Average Residual Limb Pain? [ Time Frame: Measurements were taken after wearing the study prostheses for four weeks. ] [ Designated as safety issue: No ]
    The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."

  • Worst Residual Limb Pain? [ Time Frame: Measurements were taken after wearing the study prostheses for four weeks. ] [ Designated as safety issue: No ]
    The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."

  • Least Residual Limb Pain? [ Time Frame: Measurements were taken after wearing the study prostheses for four weeks. ] [ Designated as safety issue: No ]
    The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."

  • Pain Interference With Activities? [ Time Frame: Measurements were taken after wearing the study prostheses for four weeks. ] [ Designated as safety issue: No ]
    The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."

  • How Bothersome Was Your Pain? [ Time Frame: Measurements were taken after wearing the study prostheses for four weeks. ] [ Designated as safety issue: No ]
    The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."


Enrollment: 12
Study Start Date: January 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Novel prosthetic pylon
Device: Transverse plane rotation adaptor pylon
Potential future practice
Active Comparator: Arm 2
rigid pylon
Device: Rigid pylon
Current clinical practice

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167778

Locations
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: Glenn K. Klute, PhD VA Puget Sound Health Care System, Seattle
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00167778     History of Changes
Other Study ID Numbers: A3611-R
Study First Received: July 1, 2005
Results First Received: October 25, 2013
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Amputation
Amputee
Artificial limbs
Gait
Locomotion
Walking

Additional relevant MeSH terms:
Amputation, Traumatic
Diabetes Mellitus
Leg Injuries
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014