Prosthetic Components and Stability in Amputee Gait

NCT00167778 | Completed Results

• 1 other identifier: A3611-R
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Leg Injuries; Traumatic Amputation

Keywords

Amputation; Amputee; Artificial limbs; Gait; Locomotion; Walking

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Secondary Outcomes (14)

• Peak External Rotation Moment of the Outside Hip While Turning

  Measurements were taken after wearing the study prostheses for three weeks.

• Peak External Rotation Moment of the Outside Knee While Turning

  Measurements were taken after wearing the study prostheses for three weeks.

• Peak External Rotation Moment of the Outside Ankle While Turning

  Measurements were taken after wearing the study prostheses for three weeks.

• Peak External Rotation Moment of the Inside Hip While Turning

  Measurements were taken after wearing the study prostheses for three weeks.

• Peak External Rotation Moment of the Inside Knee While Turning

  Measurements were taken after wearing the study prostheses for three weeks.

Study Arms (2)

Arm 1

EXPERIMENTAL

Novel prosthetic pylon

Device: Transverse plane rotation adaptor pylon

Arm 2

ACTIVE COMPARATOR

rigid pylon

Device: Rigid pylon

Interventions

Transverse plane rotation adaptor pylon DEVICE

Potential future practice

Arm 1

Rigid pylon DEVICE

Current clinical practice

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Leg Injuries; Amputation, Traumatic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Wounds and Injuries

Limitations and Caveats

Our sample population consisted of community ambulators whose results may not generalize to all lower limb amputees.

Results Point of Contact

• Title: Glenn K. Klute, PhD
• Organization: Dept. of Veterans Affairs, Rehabilitation Research & Development Service

Glenn.Klute@va.gov

206-277-6724

Study Officials

• Glenn K. Klute, PhD

  VA Puget Sound Health Care System, Seattle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: September 14, 2005
• Study Start: January 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

US (1)