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

Southern California Institute for Research and Education

Status: Unknown

Conditions: Artificial Limbs; Kinetics; Amputation; Energy Expenditure

Treatments: Device: Lower Limb Powered Knee-Ankle Prosthesis

Study type: Observational

Funder types: Other

Identifiers

NCT02366702

01329

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Individuals with Bilateral Transfemoral Amputation

Treatment:

Device: Lower Limb Powered Knee-Ankle Prosthesis