Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kennesaw State University | OTHER |
Not provided
Not provided
Not provided
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Layered Low Profile Foot (LPF) vs. Prescribed Ankle | Experimental | In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle. |
|
| Prescribed Ankle vs. Layered Low Profile Foot (LPF) | Experimental | In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Layered Low Profile Foot | Device | The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Energy Stored (TES) | 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. | through study completion, an average of 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Quasi-Stiffness (AQS) | AQS 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. | through study completion, an average of 1 day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennesaw State University | Kennesaw | Georgia | 30144 | United States |
6 of 6 patients completed this crossover study.
6 subjects were enrolled between 3/21/2024 and 7/16/2024 at Kennesaw State University.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Energy Stored (TES) | 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. | Posted | Mean | Standard Deviation | Joules | through study completion, an average of 1 day |
|
For each intervention, the period of time for adverse event monitoring was the 3 to 4 hour period during which the device was worn for the in-lab gait sessions. The participants did not wear the experimental intervention for home or daily use in this study.
The risks associated with study participation are no greater than minimal risk as defined in 45 CFR 46.102(i): "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prescribed Ankle | Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Geil | Kennesaw State University | (470) 578-4805 | mgeil@kennesaw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 13, 2025 | Aug 13, 2025 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The control prosthesis and the experimental prosthesis are covered by a sock to prevent the participant from knowing which has been fit.
|
| Prescribed Ankle | Device | The prescribed ankle is the prosthetic ankle that the subject wears for daily use. |
|
|
| Walking Speed | This is the linear rate of change of position when a person walks, typically given in m/s. | through study completion, an average of 1 day |
| Likert Scale Rating of Device Satisfaction | A 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. | through study completion, an average of 1 day |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Ankle Quasi-Stiffness (AQS) | AQS 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. | Posted | Mean | Standard Deviation | Newton meters per degree | through study completion, an average of 1 day |
|
|
|
| Secondary | Walking Speed | This is the linear rate of change of position when a person walks, typically given in m/s. | Posted | Mean | Standard Deviation | Meters per second | through study completion, an average of 1 day |
|
|
|
| Secondary | Likert Scale Rating of Device Satisfaction | A 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. | Posted | Mean | Standard Deviation | units on a scale | through study completion, an average of 1 day |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Layered Low Profile Foot (LPF) | Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided