Prosthetic Components and Stability in Amputee Gait
Prosthetic Components and Stability in Amputee Gait
ClinicalTrials.gov
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, May 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00167778
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
MedlinePlus related topics: Amputees Diabetes Leg Injuries and Disorders
U.S. FDA Resources
Study Type:
Interventional
Study Design:
Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study
Official Title:
Turning Corners: Prosthetic Components and Stability in Amputee Gait
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
* Transverse plane torque [ Time Frame: Measurements will occur following a three week acclimation period for each intervention ] [ Designated as safety issue: No ]
Estimated Enrollment:
40
Study Start Date:
January 2005
Estimated Study Completion Date:
September 2008
Estimated Primary Completion Date:
September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Novel prosthetic pylon
Device: Transverse plane rotation adaptor pylon
Potential future practice
2: Active Comparator
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:
25 Years to 55 Years
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
Yes
Criteria
Inclusion Criteria:
*
Amputee Subjects:
1. be a unilateral trans-tibial amputee between the ages of 25 and 55,
2. wear a patellar-tendon bearing socket and gel liner with a distal locking pin suspension,
3. been a prosthetic user for at least one year,
4. wear the prosthesis at least 6 hours per day and be moderately active,
5. ambulate without upper extremity aids,
6. have no history of injurious falls within the previous six months,
7. must be a community ambulatory (Medicare activity level 3), and
8. must not utilize any prosthetic foot/ankle or pylon components that include rotation adapters,
9. must not have a significant neurological deficit that might impact gait characteristics,
10. must not have an underlying musculoskeletal disorder that might alter gait characteristics,
11. must not have a history of skin breakdown on the residual limb, and
12. exhibit no diabetic changes to the sound limb.
* Non-amputee subjects participating in this investigation will meet similar inclusion criteria except for those related to prosthesis use.
Exclusion Criteria:
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167778
Contacts
Contact: Janice A Pecoraro, RN (206) 764-2962
Contact: Wesley Edmundson (206) 277-2991 wesley.edmundson@va.gov
Locations
United States, Washington
VA Puget Sound Health Care System, Seattle Recruiting
Seattle, Washington, United States, 98108
Contact: Ricardo Gonzalez 202-254-0196 ricardo.gonzalez@va.gov
Principal Investigator: Glenn K. Klute, PhD
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Glenn K. Klute, PhD VA Puget Sound Health Care System, Seattle
More Information
Click here for more information about this study: Turning Corners: Prosthetic Components and Stability in Amputee Gait This link exits the ClinicalTrials.gov site
Responsible Party:
Department of Veterans Affairs ( Klute, Glenn - Principal Investigator )
Study ID Numbers:
A3611R
First Received:
July 1, 2005
Last Updated:
May 6, 2008
ClinicalTrials.gov Identifier:
NCT00167778 [history]
Health Authority:
United States: Federal Government
Keywords provided by Department of Veterans Affairs:
Amputation
Amputee
Artificial limbs
Gait
Locomotion
Walking
Study placed in the following topic categories:
Metabolic Diseases
Wounds and Injuries
Diabetes Mellitus
Endocrine System Diseases
Disorders of Environmental Origin
Leg Injuries
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Amputation, Traumatic
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