Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04599530 |
| Other study ID # |
VUB-Axiles |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Vrije Universiteit Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Talaris Demonstrator is developed in continuation of previous prototypes called the
AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of
TD during daily activities.
Description:
A within study design will be conducted in order to evaluate four different prosthetic
devices (current, non-propulsive TDF, propulsive TDF and Cyberlegs) with ten participants.
Prior to the baseline test, a familiarization trial aimed to accustom participants to the
experimental protocol, to get used to the measurements and interface of the measurement
devices. The baseline experimental trial is implemented to evaluate the current prosthesis
during the different tests. The same tests will be performed during the evaluation of the
other devices. Participants are asked to perform the following consecutive tasks with ten
minutes of rest in between each task. The first task is a stair climbing test where
participants' will be asked to ascend and descend a staircase. Participants start in front of
the staircase and are asked to ascend and descend as fast as possible. Bilateral handrails
are required to allow support when needed. The ascending phase is initiated with the
prosthetic side, while the first step of the descending phase is performed with the
non-involved leg. The second task is the L-test, where participants are asked to rise from a
chair, walk through an office door, turn 90 degrees, walk down a hallway, turn 180 degrees
and then return in the same way to the seated position. A total distance of 20 meter will be
covered. The slope walking test assesses the participants' ability to ascend and descend an
inclined ramp as fast as possible. For safety reasons bilateral handrails are warranted.
Participants start the test in an upright position in front of the ramp and are asked to
ascend the ramp, turn around on the platform, descend the ramp and return to the starting
position. During a two-minute walk test, participants are asked to respond as fast as
possible to a stimulus visualized on a computer screen one meter in front of the treadmill.
Finally, a hallway six-minute walk test will be performed on a hallway at a self-selected
walking speed, which closely relates to the most efficient walking speed.
In between each test with a novel device, participants need accustom to the novel device to
ensure a good alignment and fitting. Participants will be fitted and aligned to the novel
device by a physiotherapist and prosthetist.
