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

• Sponsor: Southern California Institute for Research and Education (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02366702
• Collaborator: Vanderbilt University (Other)
• Enrollment: 3
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation; Artificial Limbs; Energy Expenditure; Kinetics	Device: Lower Limb Powered Knee-Ankle Prosthesis

Study Design

• Study Type: Observational
• Actual Enrollment: 3 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2017
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Individuals with Bilateral Transfemoral Amputation	Device: Lower Limb Powered Knee-Ankle Prosthesis

Outcome Measures

Primary Outcome Measures

1. Sagittal Plane Hip Moment [During the stance phase of the gait cycle after two weeks of training with powered device.]

2. Metabolic Cost of Transport [5 minutes of steady state walking after two weeks of training with powered device.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Long Beach Healthcare System	Long Beach	California	United States	90822

Sponsors and Collaborators

• Southern California Institute for Research and Education
• Vanderbilt University

Investigators

• Principal Investigator: Michael Goldfarb, Ph.D., Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Dana Craig, Health System Specialist, Southern California Institute for Research and Education
• ClinicalTrials.gov Identifier: NCT02366702
• Other Study ID Numbers: 01329
• First Posted: Feb 19, 2015
• Last Update Posted: Apr 5, 2019
• Last Verified: Apr 1, 2019

Study Results

No Results Posted as of Apr 5, 2019