Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05365594 |
Other study ID # |
IRB202102519 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 18, 2022 |
Est. completion date |
February 8, 2025 |
Study information
Verified date |
November 2023 |
Source |
University of Florida |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Walking boots are a common form of durable medical equipment Orthopaedic surgeons prescribe
both post-operatively and in the treatment of lower extremity injuries. Walking boots create
a limb length discrepancy (LLD) which effects joint angles and moment arms in the lower
extremities and the spine. These altered mechanics lead to reported back, hip, and knee pain
in patients who are prescribed walking boots. Current walking boot literature evaluates gait
and ground reaction forces (GRF), focusing primarily on the lower extremities, neglecting the
remainder of the kinetic chain including the spine. Alternatively, there is a body of
literature evaluating the effects of congenital LLD on spine and posture. However, there is
paucity in the literature reporting both the effects of a walking boot on the entire
kinematic chain and the subsequent effects of a corrective foot lift. The investigators seek
to evaluate lower extremity and spinal kinematics using a motion analysis capture system with
healthy subjects undergoing walking trials while wearing normal shoes, a walking boot, and a
walking boot with contralateral foot lift. The investigators hypothesize a corrective foot
lift will decrease the asymmetrical effects of a walking boot, recreating the kinematics of a
more normal gait.
Description:
The goal of this study is to understand the kinematic effects of a walking boot on joint
angles, moment arms and ground reaction forces in the spine and lower extremities.
Additionally, the investigators will examine the effects a corrective foot lift, EVENup, has
on these variables. This goal will be accomplished through (2) aims:
Aim 1. Compare the differences in kinetics and kinematics of the spine and lower extremities
during normal gait and wearing a walking boot.
Aim 2. Compare spine and lower extremity kinetics and kinematics differences in a walking
boot with and without the use of a corrective foot lift on contralateral leg.
Hypothesis: A contralateral foot lift will significantly reduce the altered mechanics created
by a walking boot. These results would encourage physicians to recommend a contralateral foot
lift when prescribing a walking boot to decrease secondary site pain.
Methodology: All subjects will participate in a gait analysis session in which their joint
kinematics and kinetics will be recorded using skin-marker motion capture and treadmill force
plates. Skin-marker motion capture involves placing reflective markers on palpable bony
landmarks, such as the medial and lateral malleoli. These reflective markers are secured to
the subject's skin using adhesive tape. Specialized, infrared cameras are then used to record
the location of these markers as the subject walks at a self-selected speed and a specified
speed denoted as faster pace. A self-selected speed will be determined by slowing increasing
the speed of the treadmill until the subject feels like they are walking at a comfortable
everyday speed. The faster pace will be determined by having the subject walk as if they are
speed walking.
Participants will complete two trials with 3 different scenarios in each trial : 1) treadmill
walking with regular shoes, 2) treadmill with walking boot and 3) treadmill with walking boot
and corrective lift. Each participant's trial order will be randomized.