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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Configuration A (Kinnex) | Active Comparator |
| |
| Configuration B (Pacifica LP) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinnex | Device | The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | 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. | 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. | Collection at baseline |
| 2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Orthotic Prosthetic User Survey (OPUS) | The OPUS is a self-reported questionnaire that asks about satisfaction with device | Collection after 4 weeks |
| Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD | Hagerstown | Maryland | 21740 | United States | ||
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 21, 2019 | |
| Reset | Sep 10, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 21, 2019 | Sep 10, 2019 |
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| Pacifica LP | Device | The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA) |
|
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.
| Collection at baseline |
| 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. | 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. | 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. | 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. | 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. | 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. | Collection after 4 weeks |
The PEQ-MS is a self-reported questionnaire that measures perceived difficulty ambulating on a variety of environmental barriers
| 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. | 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. | 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. | Collection at baseline and after 4 weeks |
| Ability Prosthetics and Orthotics, Inc. - Charlotte, NC |
| Charlotte |
| North Carolina |
| 28211 |
| United States |
| Ability Prosthetics and Orthotics, Inc. - York, PA | York | Pennsylvania | 17403 | United States |