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

• Conditions: Amputation; Kinetics; Artificial Limbs; Energy Expenditure
• Interventions: Device: Lower Limb Powered Knee-Ankle Prosthesis

• Registration Number: NCT02366702
• Lead Sponsor: Southern California Institute for Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Primary Completion: 2017-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with Bilateral Transfemoral Amputation	Lower Limb Powered Knee-Ankle Prosthesis	-

Primary Outcome Measures

Name	Time	Method
Sagittal Plane Hip Moment	During the stance phase of the gait cycle after two weeks of training with powered device.
Metabolic Cost of Transport	5 minutes of steady state walking after two weeks of training with powered device.

Trial Locations

Locations (1)

VA Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States