Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction
NCT ID: NCT03204513
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
15 participants
INTERVENTIONAL
2016-12-31
2025-12-31
Brief Summary
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Detailed Description
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The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using a powered knee-ankle prosthesis, identify task-specific training strategies for every-day device use, and quantify functional performance and quality of life changes at home and in the community. The hypothesis is that the powered knee-ankle prosthesis will demonstrate a significant improvement in function over existing technology. Furthermore, the hypothesis is that incorporating neural control information will provide enhanced, intuitive control of this device. Thus the approach is to directly compare the powered device with current state-of-art passive microprocessor controlled (MP) prostheses using a randomized cross-over study to control for subject-specific variation.
1.1 Aim 1: Perform in-laboratory training and testing to compare gait biomechanics and clinical performance over several ambulation modes using either a passive prosthesis or a powered prosthesis. The expectation is the PKA prosthesis to enable gait kinetics and kinematics that more closely resemble those of individuals with intact limbs, therefore lowering the biomechanical and metabolic effects of ambulation.
1.2 Aim 2: Perform home trials to evaluate community mobility and social interaction when using a powered knee-ankle prosthesis or a passive device. The expectation is that participants will choose to complete more diverse functional, occupational, and recreational activities when using the PKA prosthesis.
1.3 Aim 3: Quantify performance with the PKA device when using a novel intent recognition algorithm that allows for seamless transitioning between activities compared to a standard control method. The expectation is that pattern recognition- based control will further improve mobility and decrease the physiological costs of ambulation compared to using the standard control method.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
NONE
Study Groups
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Vanderbilt Powered Knee-Ankle Prosthesis
Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using the Vanderbilt Powered Knee-Ankle (PKA) Prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions using the Vanderbilt Powered Knee-Ankle (PKA) Prosthesis. The device participants begin with will be randomly selected but there will be an equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.
Vanderbilt Powered Knee-Ankle Prosthesis
The Vanderbilt powered prosthesis is a transfemoral prosthesis with powered and coordinated knee and ankle joints. The Generation 3 prosthesis is actuated by two brushless direct current (DC) motors, providing up to 100 Nm of torque at the knee joint, and with the assistance of a parallel stiffness, up to 200 Nm in plantar flexion at the ankle. Sensors measure knee and ankle joint angles, axial load in the shank, and position and orientation of the prosthesis in space (via a 6-axis inertial measurement unit). An onboard lithium-ion battery provides sufficient energy for approximately 10,000 steps between battery charges. The prosthesis prototype weighs approximately 4.3 kg (9.5 lb), the mass of which is approximately equivalent to the intact limb of a 48 kg (105 lb) person.
Microprocessor (MP) Knee Prosthesis
Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using their own Microprocessor (MP) Knee Prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions using the Microprocessor (MP) Knee Prosthesis. The device participants begin with will be randomly selected but there will be an equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.
Microprocessor (MP) Knee Prosthesis
Participants enrolled will already have their own microprocessor controlled (MP) non-powered knee prostheses as per inclusion criteria. Examples: OttoBock's C-Leg, Ossur's Rheo, Freedom Plie, Endolite Orion,etc.
Interventions
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Vanderbilt Powered Knee-Ankle Prosthesis
The Vanderbilt powered prosthesis is a transfemoral prosthesis with powered and coordinated knee and ankle joints. The Generation 3 prosthesis is actuated by two brushless direct current (DC) motors, providing up to 100 Nm of torque at the knee joint, and with the assistance of a parallel stiffness, up to 200 Nm in plantar flexion at the ankle. Sensors measure knee and ankle joint angles, axial load in the shank, and position and orientation of the prosthesis in space (via a 6-axis inertial measurement unit). An onboard lithium-ion battery provides sufficient energy for approximately 10,000 steps between battery charges. The prosthesis prototype weighs approximately 4.3 kg (9.5 lb), the mass of which is approximately equivalent to the intact limb of a 48 kg (105 lb) person.
Microprocessor (MP) Knee Prosthesis
Participants enrolled will already have their own microprocessor controlled (MP) non-powered knee prostheses as per inclusion criteria. Examples: OttoBock's C-Leg, Ossur's Rheo, Freedom Plie, Endolite Orion,etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* K2/K3/K4 level ambulators
* Required to use a microprocessor knee on their prosthesis
Exclusion Criteria
* Inactive, physically unfit
* Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
* Pregnant women
* Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)
18 Years
80 Years
ALL
No
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Principal Investigator
Principal Investigators
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Arun Jayaraman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00200842
Identifier Type: -
Identifier Source: org_study_id
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