The aim of this study is to quantify the 3D movement of skin-mounted markers on the foot relative to the bone locations they represent and their effect on the calculated foot kinematics.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the 3D movement of the skin-mounted markers with
respect to their corresponding bones and the effect of these soft tissue
artifacts on the foot kinematics as calculated by several multi-segment foot
models.
Secondary outcome
Other study parameters included are age, length, weight, foot posture index,
foot length and width, range of motion in the ankle, soft tissue between the
bone and skin of the foot.
Background summary
Knowledge about foot kinematics during gait can assist in treatment planning of
patients with foot problems (e.g. cerebral palsy). These kinematics are
determined with skin-mounted markers that represent bony landmarks. However,
relative motion is shown between skin-mounted markers and corresponding bones
of the lower leg and foot (i.e. soft tissue artifacts). These soft-tissue
artifacts (STA) result in altered axes of the local coordinate systems of the
joints and therewith possibly incorrect kinematics. Therefore, STA should be
quantified to determine their influence on the calculated foot kinematics.
Research has been conducted on STA with intra-cortical percutaneous pins and 2D
imaging. However, pins are very invasive and have other negative effects on the
outcome measure and STA measured with 2D imaging do not provide the complete
picture and are therefore not really applicable to 3D gait analysis. Hence, we
developed a CT-scan protocol to be able to overcome these issues and quantify
STA. With that knowledge, models can be improved, which eventually improves
treatment decisions. This study will be the first that quantifies STA in 3D of
all the markers of the two most frequently used multi-segment foot models and
their effect on the estimated kinematics.
Study objective
The aim of this study is to quantify the 3D movement of skin-mounted markers on
the foot relative to the bone locations they represent and their effect on the
calculated foot kinematics.
Study design
Observational study
Study burden and risks
The radiation exposure of the series of CT scans was optimised by performing a
pilot study in a cadaveric specimen, in which the minimal acceptable dose was
determined. The total exposure for the participants for all the scans combined
is estimated to be 0.09 mSv. The exposure is within the category I (<0.1 mSv)
of the International Commission on Radiological Protection (ICRP), which
qualifies as: trivial risk.
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Subject must be over the age of 18 years and be willing and able to give informed consent
Exclusion criteria
Exclusion criteria are:
- Wearing insoles or something similar
- A right ankle or foot injury in the last 3 months
- A history of trauma or surgeries on the right ankle or foot
- A hindfoot to lower leg range of motion which is less than:
- 40° plantar flexion
- 20° dorsal flexion
- 10° varus/inversion
- 10° valgus/eversion
- Pregnancy
- Not being able to understand the written informed consent
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 | NL66940.018.18 |