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

NCT02366702 | Unknown

• 1 other identifier: 01329
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Artificial Limbs; Energy Expenditure; Kinetics

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Individuals with Bilateral Transfemoral Amputation

Device: Lower Limb Powered Knee-Ankle Prosthesis

Interventions

Lower Limb Powered Knee-Ankle Prosthesis DEVICE

Individuals with Bilateral Transfemoral Amputation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• Vanderbilt University: collaborator

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

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Study Officials

• Michael Goldfarb, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health System Specialist

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

US (1)