Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05425810 |
| Other study ID # |
23949 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2021 |
| Est. completion date |
August 30, 2024 |
Study information
| Verified date |
June 2022 |
| Source |
North Carolina State University |
| Contact |
Ming Liu, PhD |
| Phone |
9195158541 |
| Email |
mliu10[@]ncsu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an
independent life. For most LLAs, a well-fitted prosthetic socket is the only option to
interface with their prosthetic leg, however, it is a real challenge to make a prosthetic
socket to interface with residual limbs accurately. One of the reasons is that there lack of
accurate approaches to evaluate the pressure distribution on the residual limb accurately and
effectively. To overcome this issue, the research team will develop an innovative sensing
system, which permits the prosthetists to track the pressure distribution on the residual
limb visually. The capability of the new sensing system will be demonstrated on lower limb
amputees.
Description:
A novel pressure sensing pad will be tested in the project. The purpose of these tests is to
collect the safety and efficacy of the sensing pad. The research team would like to seek a
Non-significant Risk claim from Institutional Review Board (IRB).
The pad will be made of materials similar to the normal liner with embedded nanotubes. The
nanotubes are filled with gallium alloys, of which resistance will change based on loaded
pressure. When constant current passes these tubes, the change of pressure leads to a change
in temperatures around, which will excite thermal-sensitive dyes to change color. So the
research team could estimate the pressure at a given area based on the color around it.
The experimental procedure includes three sets and requires 3-4 visits from each subject.
Set I procedure includes a standard socket construction, which requires 2-3 visits for the
subjects to the office of a local prosthetic company. Then, a certified prosthetist will
build a test socket and a customized liner to maximize the socket fit and comfort and conduct
the needed alignment of the prosthetic leg. Unless it is necessary, all testing sockets will
be duplications of amputees' everyday sockets.
Set II will test the accuracy of the constructed prototype on amputee subjects compared to a
commercially available sensor pad, which serves as a reference. First, the research team will
mount both sensing systems on the subjects. The reference sensor grid will be mounted on the
residual limb directly using medical tape. After the subject dons the ENABLE sensing pad, the
research team will register two sensing systems. In the end, the subjects are required to don
the testing socket and walk continuously, so the measurement of the developed prototype could
be stabilized. Pictures of the ENABLE will be taken and compared with the recorded pressure
signals from the reference grid.
Although the reference grid and ENABLE system are designed to be put on easily, brief
assistance from experimenters will be needed to ensure that the mounting procedure can be
conducted appropriately.
Set III will test whether information from the ENABLE leads to appropriated
socket-fit-assessments based on the response of experienced prosthetists when the
prosthetists are shown the pressure distribution measured by the ENABLE under different fit
conditions. All subjects will be exposed to five socket fit conditions: good and additional
foam pads at four different areas shown in a random sequence. The size of the pad at each
location is selected by the prosthetists based on the shape and size of the residual limbs.
Under each fitting condition, each subject will go through three trials. In each trial, the
subject will walk continuously until the color of the sensing pad is stabilized. After taking
high-resolution digital pictures, which cover most of the sensing area of the ENABLE, the
research team will let the subject rest until the optical pattern of the ENABLE fades
completely before starting a new trial.
After the experiments are finished, the subject will need to fill out a survey about the
comfort of the ENABLE system. The survey will be conducted just after the experimental
procedure on paper. During Set II and III, a fall prevention harness is available for the
participants if it is needed. The participants are requested to self-monitor the pressure and
thermal conditions on their residual limbs and encouraged to request the early termination of
the experimental procedure.
