Healthy Clinical Trial
Official title:
Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design
Soldiers and recreational backpackers are often required to carry heavy loads on their body
during military operations or hiking. Despite the advances in backpack design, the loads
carried by soldiers still impose an extreme physiological strain (soft tissue deformation)
which frequently results in discomfort, pain,musculoskeletal injuries, and loss sensorimotor
function.
In the current study, characterization of the pressures, evaluation of the deformations of
the soft tissues, specifically the fat, muscles, Brachial plexus and subclavian vessels
applied on the shoulder while sitting with a heavy backpack will performed. The data
acquired in the current trials will be used for development of a finite element (FE) 3D
shoulder model. The purpose is to better understand the mechanical loads that are being
transferred to the underlying tissue below the shoulder straps during walking/marching with
a backpack. During the 2nd phase of this project, data collected during this research will
be used to develop gear that will alleviate the strain on the shoulders, prevent injury, and
enhance performance.
Hypothesis
- High focal strain (hot-spots) on the shoulder tissue that are observed with the
pressure mapping will be observed also in the MR scans.
- The strain at those hot-spots can be reduced by personal-geometry adjusted straps.
Volunteers
Five young (18-30 yrs), healthy, and fit males will participate in this study.
Trials design
1. MR Scans- The scan will be performed for analysis of personal shoulder anatomy, and
will be used for developing a 3D FE model. The sagittal view will be used to develop
the 3D model. The coronal and axial sectional views will be used to assess the
deformations applied on the shoulder tissue. The scan will then be repeated while
carrying a 25 kg standard commercial backpack while sitting in the same position, for
the assessment of shoulder girdle tissues deformations. Time estimation for each scan
is 40 min (80 min total). The subjects are not required to carry the backpack prior to
those scans.
2. Static pressure measurement- each volunteer will be asked to sit for 30 seconds while
carrying the 25 kg backpack. During this session, pressure will be measured using a
pressure mapping pad (Sensor Products Inc., USA) placed between the shoulder strap and
the underlying tissue.
The maximal total participation time of each volunteer will be 2 hours total (inside and
outside the MR).
Data acquired in the current trials will be used for the development of a FE (finite
element) 3D shoulder model. MR scans will be utilized for composing geometry and for the
boundary conditions assessment (strain magnitude). Pressure measurements will be used as
boundary conditions (stress magnitude).
MR scans and pressure measurements will be performed in the Sheba medical center facilities.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |