The primary objectives of this study are to: 1) create a database of WB and non-WB MRI scans from the feet of 20 healthy subjects, 2) evaluate the morphological differences in the human foot under WB and non-WB conditions to assess the impact of…
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Brief title
Condition
- Other condition
Synonym
Health condition
Voetdeformiteiten, maar niet in deze studie met gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are (1) a workflow that creates a database of WB and
non-WB MRI scans from the feet of 20 healthy subjects; (2) the difference in
foot morphology between WB and non-WB conditions; (3) validation of the FEM by
using the input of the healthy feet to match and compare the PP with empirical
data of a pressure plate.
Secondary outcome
Secondary study parameters are (1) a relatively simple initial SSM of the foot
that is developed by using the foot data of the 20 healthy subjects; (2) the
plantar pressure of the healthy foot.
Background summary
Foot deformities occur in multiple planes and cause pain and mobility issues in
patients. Surgeons currently freehandedly reconstruct such feet using 2D
X-rays. However, the patients optimal foot shape and the postoperative pressure
distribution of the foot are unknown preoperatively. Predicting this optimal
foot shape and pressure distribution could enhance surgical precision,
efficiency, and reduce complications like recurrence of ulcers and amputation.
A statistical shape model (SSM) of the healthy foot offers a potential solution
to predict the patients optimal foot shape, by capturing the mean foot shape
and its variations. An explorative and simplified SSM will be developed using
MRI data from 20 healthy participants in weight-bearing (WB) and
non-weight-bearing (non-WB) conditions. This database is yet to be created by
including 20 healthy subjects and scanning their feet in a WB and non-WB MRI
scanner. Current SSMs are based on supine MRI or CT scans and therefore do not
reflect real-life conditions influenced by gravity. WB MRI allows the
assessment of biomechanical and anatomical adaptations of the foot under
gravitational forces, addressing this gap. Although this study involves a
limited sample size, it lays the groundwork for future SSM development,
estimating the data needed for a proper functioning SSM. Additionally, the
study explores finite element modeling (FEM) based on WB MRI data and pressure
plate measurements of the subjects* feet to preoperatively simulate the plantar
pressure (PP) distribution of the foot.A validated FEM could predict pressure
points preoperatively, reducing the risk of ulcers and reoperations. The FEMs
accuracy is validated by comparing its PP predictions with actual pressure
plate measurements in healthy subjects. In the future, this simulation may help
in the preoperative prediction of the postoperative pressure distribution of
the foot.
Study objective
The primary objectives of this study are to: 1) create a database of WB and
non-WB MRI scans from the feet of 20 healthy subjects, 2) evaluate the
morphological differences in the human foot under WB and non-WB conditions to
assess the impact of gravitational loading on bone configuration, and 3) match
and validate a FEM by comparing the predicted plantar pressure (PP)
distribution with empirical data from a pressure plate. The secondary
objectives include: 1) developing an initial, relatively simple SSM of the foot
based on the data from the 20 healthy subjects, modelling the foot shape as two
segments: the soft tissue envelope and all bones as a single segment, and 2)
identifying the plantar pressure distribution of the healthy foot using the
mean shape that is obtained from the initial SSM.
Study design
Observational cross-sectional study with an explorative nature.
Study burden and risks
This study is classified as non-therapeutic research involving capacitated
adults. The primary risk to subjects is exposure to MRI scanning in both
standing and lying positions, which is considered a minimal risk procedure with
no known significant adverse effects. The standing MRI has a magnetic field
strength of 0.25T and the lying MRI has a field strength of 1.5T, both of which
are considered safe for routine imaging. There is no risk involving the
pressure plate measurements. There are no direct benefits to the participants
in this study. However, the research contributes valuable knowledge in the
field of foot morphology, which in the far future may aid in more accurate foot
surgeries and better post-operative outcomes for patients. The burden to
participants, including the time commitment for MRI scans and the potential
discomfort of standing in the scanner, is minimal and proportional to the
potential scientific value of this research.
Zilvermeeuw 1
Almelo 7609PP
NL
Zilvermeeuw 1
Almelo 7609PP
NL
Listed location countries
Age
Inclusion criteria
This study includes healthy participants. A healthy participant is defined as a
person who:
Does not have a foot deformities like hallux valgus, Charcot foot, severe pes
planus or pes cavus or a clubfoot.
Does not have a medical history of foot surgeries
Has no current foot pain or functional limitations at rest, or when walking or
standing on bare foot
Has no neurological or systemic conditions affecting foot structure or sensory
and motor functions of the foot (e.g. diabetes mellitus, rheumatoid arthritis,
neuropathies)
Has a normal mobility and does not use walking aids.
Does not have vascular conditions affecting circulation in the foot.
The investigators expect to have a normal pressure plate profile. A normal
pressure plate profile is characterized by:
A plantar pressure distribution consistent with a physiological gait pattern,
with the highest pressure peaks located under the heel, the first and fifth
metatarsals, and the hallux.
A smooth roll-off of the foot, without extreme lateralization or medialization
of the pressure distribution.
Other inclusion criteria to be eligible to participate in this study are:
Age: Between 18 and 65 years
Sex: Both biological female and male participants will be included.
Informed Consent: the participant must be able to understand and provide
informed consent regarding the nature and goals of the study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
Participants who do not wish to be informed about unexpected medical findings
Foot Deformities: Presence of significant foot deformities.
Neuropathy: Any history of neuropathy or conditions affecting foot sensation.
Foot Surgery: History of foot surgery that may alter anatomical or
biomechanical characteristics.
Amputation: Any amputation of (part of) the lower extremities.
Skin Conditions: Any abnormal skin conditions, including ulcers or open wounds
on the foot.
Medical Implants: Presence of any medical implants or devices that may
interfere with MRI imaging.
Inability to stand for a period of 5 minutes.
Pregnancy: The exclusion of pregnant women is not only due to the safety
concerns of contrast agents, as no contrast is used in the MRI scans for this
study. Hormonal changes that can affect foot structure, potentially influencing
result interpretation, were also considered.
MRI Safety: Any other condition that would make MRI unsafe or unreliable.
Height > 200 cm
Weight > 150 kg
Can people with flat feet or orthotics participate?
People with mild flat feet (pes planus) or high arches (pes cavus) can
participate if they do not have functional complaints or pain at rest or when
walking or standing on bare foot. In such cases, their pressure profile is
considered part of the natural variation within a healthy population. If
abnormal pressure distributions are measured, these can be analysed as a
subgroup within the healthy participants.
People who wear orthotics can only participate if they exhibit a physiological
gait pattern and pressure distribution without orthotics during the measurement
and if they have no functional complaints or pain at rest or when walking or
standing on bare foot.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88645.091.24 |