Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction
Overview
- Phase
- N/A
- Intervention
- Vanderbilt Powered Knee-Ankle Prosthesis
- Conditions
- Transfemoral Amputees
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Change in Biomechanical Assessment [Gait Parameters and Surface Electromyography (EMG) Activation] Between Devices
- Status
- Active, Not Recruiting
- Last Updated
- 10 days ago
Overview
Brief Summary
The overall goal of this research is to determine the efficacy of new powered prosthetic devices for individuals with transfemoral amputations. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using PKA prosthesis and quantify functional performance and quality of life changes.
Detailed Description
The overall goal of this research is to bring powered devices, with suitable advanced control systems, to the clinic and home. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. 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.
Investigators
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab
Eligibility Criteria
Inclusion Criteria
- •Unilateral transfemoral level limb loss or limb difference
- •K2/K3/K4 level ambulators
- •Required to use a microprocessor knee on their prosthesis
Exclusion Criteria
- •Over 250 lbs body weight
- •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.)
Arms & Interventions
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.
Intervention: Vanderbilt Powered Knee-Ankle Prosthesis
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.
Intervention: Microprocessor (MP) Knee Prosthesis
Outcomes
Primary Outcomes
Change in Biomechanical Assessment [Gait Parameters and Surface Electromyography (EMG) Activation] Between Devices
Time Frame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
Surface EMG recording of specific muscles will be recorded during walking. The EMG electrodes detect electrical signals of the muscles. Reflective markers will be placed at specific locations on the upper and lower extremity joint/bony landmarks to record the motion while walking. The locations of the markers in space will be recorded by an infrared based multi-camera system during walking indoors on tile and over force plates.
Change between devices of the Modified Graded Treadmill Test
Time Frame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
This test is used to determine participant's endurance while walking at different speeds on a motorized treadmill. Participants will be secured to an overhead safety harness during this test. Participants will walk for up to 2 minutes each at different speeds on the treadmill. The treadmill speeds will be varied between 0.2 meters/second up to 2.0 meters/second at increments of 0.2 meters/sec. Close to the end of every 2 minute walk period, the participant will be asked to rate the perceived exertion for the walking task. Before incrementing the speed and continuing with the test, participants will be asked if participants would like to continue to walk and if the speed can be incremented. Participants metabolic and heart rate will be monitored frequently and recorded during this test. A physical exertion rating scale will be used to record participant's perceived exertion during every 2 minutes throughout the trial.
Secondary Outcomes
- Hill Assessment Index (HAI)(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Stair Assessment Index (SAI)(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- GAITRite® Data Capture(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- 4-Square Step Test(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Change in Manual Muscle Test (MMT)(Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Change in Passive Range of Motion (PROM)(Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- 6 Minute Walk Test (6MWT) with COSMED K4B2 Metabolic unit(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Change in Active Range of Motion (AROM)(Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Amputee Mobility Predictor(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Outdoor Uneven Surfaces Test(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Mini Mental State Exam (MMSE)(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Cross Walk Blinking Signal Test(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- 5 Times Sit to Stand Test (5XSST)(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))
- Talks While Walking Test (TWWT- Dual task test)(Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment))