Trial Outcomes & Findings for Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot (NCT NCT06468059)
NCT ID: NCT06468059
Last Updated: 2025-09-17
Results Overview
TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
through study completion, an average of 1 day
Results posted on
2025-09-17
Participant Flow
6 subjects were enrolled between 3/21/2024 and 7/16/2024 at Kennesaw State University.
6 of 6 patients completed this crossover study.
Participant milestones
| Measure |
Layered Low Profile Foot (LPF) vs. Prescribed Ankle
In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Prescribed Ankle vs. Layered Low Profile Foot (LPF)
In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
Baseline characteristics by cohort
| Measure |
Layered Low Profile Foot (LPF) vs. Prescribed Ankle
n=3 Participants
In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Prescribed Ankle vs. Layered Low Profile Foot (LPF)
n=3 Participants
In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 dayTES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.
Outcome measures
| Measure |
Prescribed Ankle
n=6 Participants
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Layered Low Profile Foot (LPF)
n=6 Participants
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.
|
|---|---|---|
|
Total Energy Stored (TES)
|
20.1 Joules
Standard Deviation 11.2
|
13.3 Joules
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 dayAQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics. The ideal AQS varies from person to person, but in this study we were interested in seeing if the prostheses could achiever lower AQS.
Outcome measures
| Measure |
Prescribed Ankle
n=6 Participants
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Layered Low Profile Foot (LPF)
n=6 Participants
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.
|
|---|---|---|
|
Ankle Quasi-Stiffness (AQS)
|
9.8 Newton meters per degree
Standard Deviation 2.7
|
9.3 Newton meters per degree
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 dayThis is the linear rate of change of position when a person walks, typically given in m/s.
Outcome measures
| Measure |
Prescribed Ankle
n=6 Participants
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Layered Low Profile Foot (LPF)
n=6 Participants
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.
|
|---|---|---|
|
Walking Speed
|
1.27 Meters per second
Standard Deviation 0.2
|
1.28 Meters per second
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 dayA 1 to 10 rating of device satisfaction where the pre-trial perceived device satisfaction of the participant's prescribed ankle is defined as a 5 out of 10. 1 is defined as completely unacceptable, and 10 is defined as ideal performance.
Outcome measures
| Measure |
Prescribed Ankle
n=6 Participants
Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.
|
Layered Low Profile Foot (LPF)
n=6 Participants
Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.
|
|---|---|---|
|
Likert Scale Rating of Device Satisfaction
|
4.3 units on a scale
Standard Deviation 1.5
|
5.2 units on a scale
Standard Deviation 1.5
|
Adverse Events
Prescribed Ankle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Layered Low Profile Foot (LPF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place