Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04468828 |
Other study ID # |
STUDY 14951 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 2021 |
Est. completion date |
January 2022 |
Study information
Verified date |
November 2021 |
Source |
Milton S. Hershey Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The analysis of human motion using radar has become an increasingly active topic of study due
to the diverse applications offered by such an analysis (Lai et al., 2008; Fairchild &
Narayanan, 2016; Narayanan et al., 2014). Information about human motion has important
applications for urban military operations, search-and-rescue missions, surveillance, and
hospital patient monitoring. The micro-motions of human movement in the presence of radar
illumination creates unique modulations in the received signal known as the micro-Doppler
effect. By analyzing these frequency modulations, one can infer the type of movement being
performed. This micro-motion associated with human movement produces a nonlinear and
non-stationary signal that can be characterized using time-frequency domain analysis. Such
signals will be used to identify high injury risk versus low injury risk athletes, which
creates an opportunity to direct limited prevention resources to these high-risk athletes;
identify individuals at risk of falls; and, may even be useful in diagnosing conditions such
as Parkinson's where asymmetrical movement patterns occur as an early indicator.
Traditional methods of movement analysis involve the use of expensive video motion capture
systems that accurately measure the 3-dimensional position of passive reflective markers
affixed to human body landmarks such as joints and body segments, and while motion capture
systems are used to effectively estimate movement dynamics, they are generally not portable,
they are expensive, and they can be cumbersome when the reflective markers are applied to
older persons or persons with movement deficiencies. Drs. Narayanan and Onks have
successfully tested a novel use of Doppler radar that is portable, less expensive, and
eliminates the need for affixing cumbersome reflective markers to participants. In addition,
preliminary testing has demonstrated the ability to discriminate between certain movement
conditions at a level of precision we feel are not obtainable with video motion capture.
Description:
Each subject will report for their scheduled data collection in the biomechanics laboratory.
Boney landmarks (shoulder, hip, knee, ankle, etc.) will be used to place small reflective
markers for use with motion capture analysis. The radar will be positioned so that the MDS
data can be captured simultaneously with the motion capture data. Each volunteer will
complete the following activities: • Walk with athletic shoes
- Walk with bilateral heel lifts in shoes
- Walk with unilateral heel lift
- Squat jump with athletic shoes
- Squat jump with bilateral heel lifts in shoes
- Squat Jump with unilateral heel lift
- Stationary standing posture with athletic shoes
- Stationary standing posture with bilateral heel lifts in shoes
- Stationary standing posture with unilateral heel lift Each activity will be performed
three times toward the radar in order to assess repeatability and reliability, and also
for maintaining adequate statistical training and testing datasets for confirming the
use of previous established classification algorithms. These algorithms will again be
used to calculate prediction accuracy for the different activities (walking, jumping,
and stationary posture) and different footwear conditions (shoes without inserts, shoes
with bilateral inserts, shoes with unilateral inserts). The biomechanical motion capture
data will be processed similarly to the MDS data to compare to accuracy between the two
methods for the same observed task-specific differences. Our goal is to determine if MDS
can achieve the same measurement accuracy as motion capture for the same task. Since
biomechanical motion capture is the "gold standard" of human movement measurement, the
successful completion of this aim will establish the validity of MDS as an effective
clinical measure of human movement.