The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.
Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited. In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)
Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD
Hagerstown, Maryland, United States
Ability Prosthetics and Orthotics, Inc. - Charlotte, NC
Charlotte, North Carolina, United States
Ability Prosthetics and Orthotics, Inc. - York, PA
York, Pennsylvania, United States
Amputee Mobility Predictor with Prosthesis (AMPPRO)
The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability
Time frame: Collection at baseline
L-Functional Test (L-Test) Baseline
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
Time frame: Collection at baseline
5 times Sit-to-Stand (5 times STS) Baseline
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
Time frame: Collection at baseline
6 minute Timed Walk Test (6m TWT) Baseline
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Time frame: Collection at baseline
Physiological Cost Index (PCI) Baseline
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Time frame: Collection at baseline
Hill Assessment Index (HAI) Baseline
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
Time frame: Collection at baseline
2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
Time frame: Collection at baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
L-Functional Test (L-Test) after 4 weeks
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
Time frame: Collection after 4 weeks
5 times Sit-to-Stand (5 times STS) after 4 weeks
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
Time frame: Collection after 4 weeks
6 minute Timed Walk Test (6m TWT) after 4 weeks
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Time frame: Collection after 4 weeks
Physiological Cost Index (PCI) after 4 weeks
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Time frame: Collection after 4 weeks
Hill Assessment Index (HAI) after 4 weeks
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
Time frame: Collection after 4 weeks
2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
Time frame: Collection after 4 weeks
Orthotic Prosthetic User Survey (OPUS)
The OPUS is a self-reported questionnaire that asks about satisfaction with device
Time frame: Collection after 4 weeks
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)
The PEQ-MS is a self-reported questionnaire that measures perceived difficulty ambulating on a variety of environmental barriers
Time frame: Collection after 4 weeks
Prosthesis Limb User Survey of Mobility (PLUS-M)
The PLUS-M is a self-reported questionnaire that measures perceived mobility with a prosthesis in different environments.
Time frame: Collection after 4 weeks
Activities-Specific Balance Confidence Scale (ABC)
The ABC is a self-reported questionnaire that measures confidence in balance while performing various activities in different environments.
Time frame: Collection after 4 weeks
Socket Comfort Score (SCS)
The SCS is a self-reported questionnaire that asks the participant to rate their current socket comfort from 0-10, with 10 points representing the most comfortable socket they can imagine.
Time frame: Collection at baseline and after 4 weeks