Clinical trial NCT02366702: Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices
Official title: Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Artificial Limbs
Energy Expenditure
Kinetics
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2015-02-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with bilateral transfemoral amputation who are community level ambulators. Individuals are ambulatory with non-powered prosthetic devices.

Brief summary: 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Sagittal Plane Hip Moment
timeFrame: During the stance phase of the gait cycle after two weeks of training with powered device.
measure: Metabolic Cost of Transport
timeFrame: 5 minutes of steady state walking after two weeks of training with powered device.
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: Vanderbilt University
name: Michael Goldfarb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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