Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices
NCT ID: NCT02366702
Last Updated: 2019-04-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
3 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-02-28
Study Completion Date
2020-02-29
Brief Summary
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The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.
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Detailed Description
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Conditions
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Amputation
Artificial Limbs
Energy Expenditure
Kinetics
Study Design
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Observational Model Type
CASE_CROSSOVER
Study Time Perspective
PROSPECTIVE
Study Groups
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Individuals with Bilateral Transfemoral Amputation
Lower Limb Powered Knee-Ankle Prosthesis
Intervention Type
DEVICE
Interventions
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Lower Limb Powered Knee-Ankle Prosthesis
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Male or female
* All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
* All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
* Subjects currently walk with entirely passive type prostheses daily.
* Subjects walk without assistive devices OR with single point cane.
* High-activity level walkers
* All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
* All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
* Subjects currently walk with entirely passive type prostheses daily.
* Subjects walk without assistive devices OR with single point cane.
* High-activity level walkers
Exclusion Criteria
* Ages \< 18 or \> 45 years
* Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
* Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
* Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
* Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.
* Low-activity level walkers
* Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
* Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
* Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
* Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.
* Low-activity level walkers
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Vanderbilt University
OTHER
Sponsor Role
collaborator
Southern California Institute for Research and Education
OTHER
Sponsor Role
lead
Responsible Party
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Dana Craig
Health System Specialist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Michael Goldfarb, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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VA Long Beach Healthcare System
Long Beach, California, United States
Site Status
Countries
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United States
References
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Other Identifiers
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01329
Identifier Type: -
Identifier Source: org_study_id
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