Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
- Conditions
- Amputation
- Registration Number
- NCT02864693
- Lead Sponsor
- Ability Prosthetics and Orthotics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
Orthotic Prosthetic User Survey (OPUS) Collection after 4 weeks The OPUS is a self-reported questionnaire that asks about satisfaction with device
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
Trial Locations
- Locations (3)
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
Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD🇺🇸Hagerstown, Maryland, United States