Amputation
Conditions
Keywords
Microprocessor Controlled Ankle, Transtibial Amputee, Pacifica LP, Kinnex
Brief summary
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.
Detailed description
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.
Interventions
DEVICEKinnex
The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
DEVICEPacifica LP
The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)
Sponsors
Ability Prosthetics and Orthotics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral transtibial amputation * Age 18-99 years old * Body weight below 275 lbs * Non-pregnant * English speaking * Current user of prosthesis for at least one year * Wear time 8 hrs/day or more * MFCL ≥ K-3 * Well-fitting and functioning prosthesis * No use of ambulatory aide * Able to tolerate testing protocol * Able to walk on slopes * Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments
Exclusion criteria
* Amputation level other than unilateral transtibial * Age \<18 or \>99 years old * Body weight above 275 lbs * Pregnant * Non-English speaking * Not current user of prosthesis * Less than one year use of prosthesis * Wear time less than 8 hr/day * MFCL \<K3 * Poor fitting and functioning prosthesis * Indicating that the socket fit is painful, or unacceptable * Use of ambulatory aide * Unable to tolerate testing protocol * Unable to walk on slopes * Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study * Any neurologic impairments known to cause gait and/or balance dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks | Collection 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. |
| L-Functional Test (L-Test) after 4 weeks | Collection 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. |
| 5 times Sit-to-Stand (5 times STS) after 4 weeks | Collection 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. |
| 6 minute Timed Walk Test (6m TWT) after 4 weeks | Collection after 4 weeks | The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes. |
| Physiological Cost Index (PCI) after 4 weeks | Collection 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. |
| Hill Assessment Index (HAI) after 4 weeks | Collection after 4 weeks | The HAI is a functional test that measures quality of walking up and down a sloped ramp. |
| Amputee Mobility Predictor with Prosthesis (AMPPRO) | Collection at baseline | The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability |
| L-Functional Test (L-Test) Baseline | Collection at 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. |
| 5 times Sit-to-Stand (5 times STS) Baseline | Collection at 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. |
| 6 minute Timed Walk Test (6m TWT) Baseline | Collection at baseline | The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes. |
| Physiological Cost Index (PCI) Baseline | Collection at 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. |
| Hill Assessment Index (HAI) Baseline | Collection at baseline | The HAI is a functional test that measures quality of walking up and down a sloped ramp. |
| 2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline | Collection at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) | Collection after 4 weeks | The PEQ-MS is a self-reported questionnaire that measures perceived difficulty ambulating on a variety of environmental barriers |
| Prosthesis Limb User Survey of Mobility (PLUS-M) | Collection after 4 weeks | The PLUS-M is a self-reported questionnaire that measures perceived mobility with a prosthesis in different environments. |
| Activities-Specific Balance Confidence Scale (ABC) | Collection after 4 weeks | The ABC is a self-reported questionnaire that measures confidence in balance while performing various activities in different environments. |
| Socket Comfort Score (SCS) | Collection at baseline and after 4 weeks | 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. |
| Orthotic Prosthetic User Survey (OPUS) | Collection after 4 weeks | The OPUS is a self-reported questionnaire that asks about satisfaction with device |
Countries
United States
Outcome results
None listed