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Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02366702
Enrollment
3
Registered
2015-02-19
Start date
2015-02-28
Completion date
2020-02-29
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Artificial Limbs, Energy Expenditure, Kinetics

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.

Interventions

DEVICELower Limb Powered Knee-Ankle Prosthesis

Sponsors

Vanderbilt University
CollaboratorOTHER
Southern California Institute for Research and Education
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sagittal Plane Hip MomentDuring the stance phase of the gait cycle after two weeks of training with powered device.
Metabolic Cost of Transport5 minutes of steady state walking after two weeks of training with powered device.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026