Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05420857 |
Other study ID # |
0902-19-EP |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2023 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
May 2024 |
Source |
University of Nebraska |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Stroke is the leading cause of serious long-term disability in the United States. Walking
speed is related to stroke severity and how well someone can return to community life.
Biofeedback is a useful method for increasing walking speed in persons post-stroke, however,
these methods are typically limited to laboratory settings. The objective of this research is
to determine the short-term response and training potential of a novel, wearable device that
provides visual feedback of hip extension during unconstrained over ground walking. The aims
of this study are to 1) determine short-term effects of visual biofeedback on biomechanical
outcomes, 2) determine the short-term effects of visual biofeedback on gait symmetry during
overground walking in individuals post-stroke. The investigators hypothesize that
biomechanical and spatiotemporal outcomes will improve following training with the wearable
biofeedback device. To assess these aims, participants' gait biomechanics will be assessed
pre- and post-training with the biofeedback device as well as 24-hours following the
training. Walking speed (primary outcome) as well as hip extension angle, propulsive force,
step width, step length, and step time will be assessed to determine changes in performance
with use of the device. By understanding short-term responses to this novel training
paradigm, research can begin assessing the potential of wearable biofeedback devices in
improving gait in persons post-stroke. Should this training prove successful, this study will
provide the necessary feasibility data to motivate a larger scale, case-control clinical
trial to determine efficacy of the device and training.
Description:
For all aims, participants will complete a first testing session where biomechanical
variables will be assessed pre- and post-training with the hip extension device. A second
testing session will be completed 24-hours following the first session where retention of
training will be assessed. Biomechanical assessments, control sessions and training sessions
are described as follows:
Biomechanical Assessments: Biomechanical Assessments will be performed to assess variables
including walking speed, hip extension angle, and propulsion. Retro-reflective markers will
be placed over anatomical landmarks using a lower-body marker set. Participants will be
instructed to walk in a straight line over a set of embedded force platforms (AMTI) while a
17-camera motion capture system (Motion Analysis Corp.) records lower-body kinematics and
kinetics. Participants will complete a total of three successful walking trials for each
assessment with a successful trial being defined as having at least one clean foot strike in
a force platform for each foot. No biofeedback will be provided during biomechanical
assessments. During the biomechanical assessments, subjects may wear a harness suspended from
the ceiling (no body-weight support) for safety. Control Session: Prior to training,
participants will undergo assessments without biofeedback. This session will be used as a
comparison for the effects of a single training session. Training: Participants will complete
three training bouts in a session. For these training bouts, participants will be instructed
to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait
biofeedback device and visual display glasses. The training bouts will each be 6 minutes in
duration with a 5-minute break in between bouts. The same training structure was successfully
used in a previous study10. The biofeedback will be intermittent, with one minute on and one
minute off, in order for the individual to not become dependent on the feedback and to
promote motor learning. Participants will be told that the device measures the angle their
paretic leg is at, and as they move their leg, the line on the screen will move. They will be
shown as they move their leg farther back, the line moves up, closer to the target.
Participants will not be given specific feedback on what walking strategies to use to
increase hip extension angle, to not bias the results. If the participant surpasses the
target hip extension angle, the target will blink green, indicating a successful trial. The
target hip extension angle is the average of the four greatest peak hip extension angles the
individual has achieves within the current training bout. Once the participant exceeds the
current target angle, a new target will be created at the new average value. This novel
feedback paradigm encourages the individual to progressively increase their peak hip
extension by providing a high, but previously achieved target goal that adapts to improved
performance in real-time. During training bouts, research personnel will follow the
participant for safety.
Clinical Assessment: Participants will complete a clinical assessment prior to biomechanical
assessments and training. Measurements from this assessment will include hip flexion and
extension range of motion, hip flexion and extension strength, plantarflexion strength, and
spasticity and will be used as covariates in analysis if significant effects are demonstrated
within a factor. Hip flexion and extension range of motion will be measured with a goniometer
while the participant is positioned on a patient table supine for flexion and prone for
extension. Research personnel will guide the limb being measured to end range of motion while
also bracing the pelvis to prevent extra motion not coming from the hip. Hip flexion and
extension and plantarflexion strength will be measured using an isokinetic dynamometer
(Biodex Medical Systems) where participants will complete three maximal voluntary
contractions in each direction for each limb with the maximum torque being recorded and used
for analysis. Spasticity will be assessed by asking participants to rate the frequency of
their spasms on a 5-point scale ranging from no spasms to spasms occurring more than 10 times
per hour, then severity of spasms will be assessed by a researcher using a 3-point scale
ranging from mild to severe.